Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

The regional analysis covers:

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Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Stem Cell Therapy Market Landscape Assessment By Type and Analysis Current Trends by Forecast To 2025 - The Daily Chronicle

Recommendation and review posted by Bethany Smith

August 17, 2020

Denver is known for its relatively mild climate and its four distinct seasons. Its also known for its temperature fluctuations over the course of a day or even hours. But what does that mean for the citys residents and for that matter, the rest of the inhabitants of the continental United States when it comes to temperature extremes?

Thats what Ashley Broadbentwanted to know. Specifically, he wanted to know how populations throughout the United States will experience heat and cold during the 21st century.

So, Broadbent, an assistant research professor in Arizona State Universitys School of Geographical Sciences and Urban Planning, used state-of-the-art modeling tools to analyze how three key variables would affect human exposure to extreme temperatures from the beginning of this century to its end.

He and his collaborator Matei Georgescu, an associate professor in the School of Geographical Sciences and Urban Planning, concentrated on the following three key factors: climate change brought about by greenhouse gas emissions, urban development-induced impacts arising from the growth of cities, and population change in individual cities.

The paper, "The motley drivers of heat and cold exposure in 21st century U.S. cities," was published onlineAug. 17 in the Proceedings of the National Academy of Sciences. It is the first study of its kind to consider population-weighted heat and cold exposure that directly and simultaneously account for greenhouse gas and urban development-induced warming.

Graphic by Alex Davis/ASU Media Relations and Strategic Communications

To describe how these three variables would affect temperatures, and in turn populations, Broadbent, Georgescu and co-author Eric Scott Krayenhoff, assistant professor at the University of Guelph, Ontario, in Canada, used a metric they dubbed person-hours, to describe humans exposure to extreme heat and cold.

Its an intuitive metric, Broadbent said. For example, when one person is exposed to one hour of an extreme temperature, that exposure equals one person-hour of exposure. Likewise, if 10 people are exposed to 10 hours of an extreme temperature, that exposure equals 100 person-hours.

I think this definition is more representative of what people experience, which is what this study is about versus a study that simply communicates temperature changes without any human element attached to it, Broadbent said.

Overall, the researchers found that the average annual heat exposure at the start of this century in the United States was about 5.2 billion person-hours. Assuming a worst-case scenario of peak global warming, population growth and urban development, the annual heat exposure would rise to 150 billion person-hours by the end of the century, a nearly 30-fold increase.

The combined effect of these three drivers will substantially increase the average heat exposure across the United States, but heat exposure is not projected to increase uniformly in all cities across the U.S., Broadbent said. There will be hot spots where heat exposure grows sharply.

To that end, the researchers defined heat thresholds based on local city definitions, something previous studies have not done. Instead, prior studies have used fixed-temperature thresholds that may be inappropriate for some cities. Afterall, a 90-degree day in Phoenix feels much different than a 90-degree day in New York City, given relative humidity differences.

Its well-known that cities have locally defined thresholds where heat and cold cause mortality and morbidity, Broadbent explained. In other words, people die at different temperatures in different cities because what is extreme in one city may be normal in another.

Importantly, areas of the United States where human exposure would increase the most is where climate change and population increase in tandem. Meanwhile, urban development has a smaller, yet not negligible effect.

According to the results of the study, the largest absolute changes in population heat exposure are projected to occur in major U.S. metropolitan regions, such as New York, Los Angeles and Atlanta.

The study also finds the largest relativechanges in person-hours related to heat exposure are projected to occur in rapidly growing cities located in the Sun Belt, including Austin, Texas; Orlando, Florida; and Atlanta.

The increase in exposure is quite large if you look at it relative to the start of the century, Broadbent said. Some cities across the Sun Belt, according to our projections, will have 90 times the number of person-hours of heat exposure. For example, cities in Texas that see substantial population growth and strong greenhouse gas-induced climate warming could be markedly affected.

One way to prepare for increased heat exposure is to reduce greenhouse gas emissions on a global scale, which would reduce the number of hours people are exposed to extreme temperatures. Other options include localized infrastructure adaptation that provides buffering effects against rising temperatures such as planting trees, providing shade and cooling areas and constructing buildings using materials that absorb less heat.

Although the average temperature in the United States will be warmer in the future, the study finds that cold exposure will increase slightly compared with the start of the century, primarily because of population growth. While there is a generaldecreasein the number of projected extreme cold events by the end of this century, the number of individuals exposed to extreme cold is projected toincrease,as population growth means that the total number of person-hours of cold exposure will go up, Broadbent said.

Cold is currently more of a national health problem than heat, but our results suggest that by the end of the century heat exposure may become a larger health problem than cold exposure, Broadbent said. However, cold exposure will not disappear completely as the climate warms. In fact, according to one of the teams simulations, Denver is projected to have more extreme cold at the end of the century compared with the beginning, according to the study.

Thats the interesting thing about climate change. We know the average temperature is going to increase, said Broadbent. But we know less about how the extremes are going to change, and often the extremes are the most important part of our daily lives.

There are several takeaway messages from this work, but one of the central ones concerns the future resiliency of our cities, Georgescu said.

The successful steps taken will require holistic thinking that embraces contributions from urban planners, engineers, social scientists and climate scientists with a long-range vision of how we want our cities to be.

"We therefore call on cities to start asking some very foundational questions regarding the projected exposure of their constituents to future environmental change," Georgescu said. "Is the work of the urban climate modeling community being integrated into their environmental adaptation plans? If so, how, and if not, why not?

This work was funded by the National Science Foundation.

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ASU engineers get to the heart of organs-on-a-chip - ASU Now

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that new data from the clinical development program for its investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including data from the Phase 2/3 Starbeam study (ALD-102) and available data from the Phase 3 ALD-104 study, will be presented at the 46th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2020), taking place virtually from August 29 - September 1, 2020.

New Cerebral Adrenoleukodystrophy (CALD) Data at EBMT 2020

Lenti-D hematopoietic stem cell gene therapy stabilizes neurologic function in boys with cerebral adrenoleukodystrophy (ALD-102 and ALD-104)Presenting Author: Dr. Jrn-Sven Khl, Department of Pediatric Oncology, Hematology and Hemostaseology, Center for Womens and Childrens Medicine, University Hospital LeipzigPoster Session & Number: Gene Therapy; ePoster O077

Additional bluebird bio data at EBMT 2020 includes encore presentations from the companys CALD, sickle cell disease (SCD), transfusion-dependent -thalassemia (TDT) and multiple myeloma programs.

Cerebral Adrenoleukodystrophy (CALD) Encore Data at EBMT 2020

Outcomes of allogeneic hematopoietic stem cell transplant in patients with cerebral adrenoleukodystrophy vary by donor cell source, conditioning regimen, and stage of cerebral disease status (ALD-103)Presenting Author: Dr. Jaap Jan Boelens, Chief, Pediatric Stem Cell Transplantation and Cellular Therapies Service, Memorial Sloan Kettering Cancer CenterPoster Session & Number: Haemoglobinopathy and inborn errors; ePoster O106

Multiple Myeloma Correlative Encore Data at EBMT 2020

Markers of initial and long-term responses to idecabtagene vicleucel (ide-cel; bb2121) in the CRB-401 study in relapsed/refractory multiple myelomaPresenting Author: Dr. Ethan G. Thompson, Bristol Myers SquibbPoster Session & Number: CAR-based Cellular Therapy clinical; ePoster A089

Sickle Cell Disease (SCD) Encore Data at EBMT 2020

LentiGlobin for sickle cell disease (SCD) gene therapy (GT): updated results in Group C patients from the Phase 1/2 HGB-206 studyPresenting Author: Dr. Markus Y. Mapara, Director, Adult Blood and Marrow Transplantation Program, Columbia University Medical CenterOral Session & Number: Inborn Errors; O080Date & Time: September 1, 2020; 4:35 4:42 PM CET/10:35 10:42 AM ET

Transfusion-Dependent -Thalassemia (TDT) Encore Data at EBMT 2020

Clinical outcomes following autologous hematopoietic stem cell transplantation with LentiGlobin gene therapy in the Phase 3 Northstar-2 and Northstar-3 studies for transfusion-dependent -thalassemiaPresenting Author: Professor Franco Locatelli, Director, Department of Pediatric Hematology and Oncology, Ospedale Pediatrico Bambino GesPoster Session & Number: Gene Therapy; ePoster O074

LentiGlobin gene therapy treatment of two patients with transfusion-dependent -thalassemia (case report)Presenting Author: Dr. Mattia Algeri, Department of Pediatric Oncohematology - Transplantation Unit and Cell Therapies, Ospedale Pediatrico Bambino GesPoster Session & Number: Haemoglobinopathy and inborn errors; ePoster A328

Cross Indication Encore Data at EBMT 2020

Safety of autologous hematopoietic stem cell transplantation with gene addition therapy for transfusion-dependent -thalassemia, sickle cell disease, and cerebral adrenoleukodystrophyPresenting Author: Dr. Evangelia Yannaki, Director, Gene and Cell Therapy Center, Hematology Department, George Papanicolaou HospitalPoster Session & Number: Gene Therapy; ePoster O078

Abstracts outlining bluebird bios accepted data at EBMT 2020 are available on the Annual Meeting website. On August 29, 2020, at 12:30 PM CET/6:30 AM ET, the embargo will lift for ePosters and oral presentations accepted for EBMT 2020. Presentations will be available for virtual viewing throughout the duration of the live meeting and content will be accessible online following the close of the meeting until November 1, 2020.

About elivaldogene autotemcel (eli-cel, Lenti-D gene therapy)In July 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted an accelerated assessment to eli-cel gene therapy for cerebral adrenoleukodystrophy (CALD). bluebird bio is currently on track to submit the Marketing Authorization Application (MAA) in the EU for eli-cel for CALD by year-end 2020, and the Biologics License Application (BLA) in the U.S. in mid-2021.

bluebird bio is currently enrolling patients for a Phase 3 study (ALD-104) designed to assess the efficacy and safety of eli-cel after myeloablative conditioning using busulfan and fludarabine in patients with CALD. Contact clinicaltrials@bluebirdbio.com for more information and a list of study sites.

Additionally, bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-304) for patients who have been treated with eli-cel for CALD and completed two years of follow-up in bluebird bio-sponsored studies.

The Phase 2/3 Starbeam study (ALD-102) has completed enrollment. For more information about the ALD-102 study visit: http://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT01896102.

Adrenoleukodystrophy (ALD) is a rare, X-linked metabolic disorder that is estimated to affect one in 21,000 male newborns worldwide. Approximately 40 percent of boys with ALD will develop CALD, the most severe form of ALD. CALD is a progressive neurogenerative disease that involves breakdown of myelin, the protective sheath of the nerve cells in the brain that are responsible for thinking and muscle control. Symptoms of CALD usually occur in early childhood and progress rapidly, if untreated, leading to severe loss of neurologic function, and eventual death, in most patients.

The European Medicines Agency (EMA) accepted eli-cel gene therapy for the treatment of CALD into its Priorities Medicines scheme (PRIME) in July 2018, and previously granted Orphan Medicinal Product designation to eli-cel.

The U.S. Food and Drug Administration (FDA) granted eli-cel Orphan Drug status, Rare Pediatric Disease designation, and Breakthrough Therapy designation for the treatment of CALD.

Eli-cel is not approved for any indication in any geography.

About idecabtagene vicleucel (ide-cel; bb2121)Ide-cel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3- chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

In addition to the pivotal KarMMa trial evaluating ide-cel in patients with relapsed and refractory multiple myeloma, bluebird bio and Bristol Myers Squibbs broad clinical development program for ide-cel includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-4) in earlier lines of treatment for patients with multiple myeloma, including newly diagnosed multiple myeloma. For more information visit clinicaltrials.gov.

In July 2020, Bristol Myers Squibb (BMS) and bluebird bio submitted the Biologics License Application for ide-cel to the U.S. Food and Drug Administration for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Ide-cel is the first CAR T cell therapy submitted for regulatory review to target BCMA and for multiple myeloma.

Ide-cel was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority Medicines (PRIME) designation, as well as Accelerated Assessment status, by the European Medicines Agency for relapsed and refractory multiple myeloma.

Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between BMS and bluebird bio.

Ide-cel is not approved for any indication in any geography.

About LentiGlobin for Sickle Cell DiseaseLentiGlobin for sickle cell disease (SCD) is an investigational gene therapy being studied as a potential treatment for SCD. bluebird bios clinical development program for LentiGlobin for SCD includes the ongoing Phase 1/2 HGB-206 study and the ongoing Phase 3 HGB-210 study.

bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-303) for people who have participated in bluebird bio-sponsored clinical studies of betibeglogene autotemcel and LentiGlobin for SCD. For more information visit: https://www.bluebirdbio.com/our-science/clinical-trials or clinicaltrials.gov and use identifier NCT02633943 for LTF-303.

SCD is a serious, progressive and debilitating genetic disease caused by a mutation in the -globin gene that leads to the production of abnormal sickle hemoglobin (HbS). HbS causes red blood cells (RBCs) to become sickled and fragile, resulting in chronic hemolytic anemia, vasculopathy and painful vaso-occlusive crises (VOCs). For adults and children living with SCD, this means painful crises and other life-altering or life-threatening acute complicationssuch as acute chest syndrome (ACS), stroke and infections. If patients survive the acute complications, vasculopathy and end-organ damage, resulting complications can lead to pulmonary hypertension, renal failure and early death; in the U.S. the median age of death for someone with sickle cell disease is 43 - 46 years.

LentiGlobin for SCD received Orphan Medicinal Product designation from the European Commission for the treatment of SCD.

The U.S. Food and Drug Administration (FDA) granted Orphan Drug status and Regenerative Medicine Advanced Therapy (RMAT) designation and rare pediatric disease designation for LentiGlobin for the treatment of SCD.

bluebird bio reached general agreement with the U.S. Food and Drug Administration (FDA) that the clinical data package required to support a Biologics Licensing Application (BLA) submission for LentiGlobin for SCD will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. The planned submission will be based on an analysis using complete resolution of severe vaso-occlusive events (VOEs) as the primary endpoint with at least 18 months of follow-up post-treatment with LentiGlobin for SCD. Globin response will be used as a key secondary endpoint.

bluebird bio anticipates additional guidance from the FDA regarding the commercial manufacturing process, including suspension lentiviral vector. bluebird bio announced in a May 11, 2020 press release it plans to seek an accelerated approval and expects to submit the U.S. BLA for SCD in the second half of 2021.

LentiGlobin for SCD is investigational and has not been approved in any geography.

About betibeglogene autotemcel (beti-cel; formerly LentiGlobin gene therapy for -thalassemia)The European Commission granted conditional marketing authorization (CMA) for betibeglogene autotemcel, marketed as ZYNTEGLO gene therapy, for patients 12 years and older with transfusion-dependent -thalassemia (TDT) who do not have a 0/0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate, but a human leukocyte antigen (HLA)-matched related HSC donor is not available. On April 28, 2020, the European Medicines Agency (EMA) renewed the CMA for ZYNTEGLO, supported by data from 32 patients treated with ZYNTEGLO, including three patients with up to five years of follow-up.

In the HGB-207 clinical study supporting the conditional marketing approval of ZYNTEGLO, the primary endpoint was transfusion independence (TI) by Month 24, defined as a weighted average Hb 9 g/Dl without any RBC transfusions for a continuous period of 12 months at any time during the study after infusion of ZYNTEGLO. Ten patients were evaluable for assessment of TI. Of these, 9/10 (90.0%, 95% CI 55.5-99.7%) achieved TI at last follow-up. Among these nine patients, the median (min, max) weighted average Hb during TI was 12.22 (11.4, 12.8) g/dLl.

TDT is a severe genetic disease caused by mutations in the -globin gene that result in reduced or significantly reduced hemoglobin (Hb). In order to survive, people with TDT maintain Hb levels through lifelong chronic blood transfusions. These transfusions carry the risk of progressive multi-organ damage due to unavoidable iron overload.

Beti-cel adds functional copies of a modified form of the -globin gene (A-T87Q-globin gene) into a patients own hematopoietic (blood) stem cells (HSCs). Once a patient has the A-T87Q-globin gene, they have the potential to produce HbAT87Q, which is gene therapy-derived hemoglobin, at levels that may eliminate or significantly reduce the need for transfusions.

Non-serious adverse events (AEs) observed during the clinical studies that were attributed to betibeglogene autotemcel included abdominal pain, thrombocytopenia, leukopenia, neutropenia, hot flush, dyspnoea, pain in extremity, and non-cardiac chest pain. Two serious adverse events (SAE) of thrombocytopenia were considered possibly related to beti-cel.

Additional AEs observed in clinical studies were consistent with the known side effects of HSC collection and bone marrow ablation with busulfan, including SAEs of veno-occlusive disease.

The CMA for beti-cel is valid in the 27 member states of the EU as well as UK, Iceland, Liechtenstein and Norway. For details, please see the Summary of Product Characteristics (SmPC).

The U.S. Food and Drug Administration granted beti-cel Orphan Drug status and Breakthrough Therapy designation for the treatment of TDT. Beti-cel is not approved in the United States.

Beti-cel continues to be evaluated in the ongoing Phase 3 Northstar-2 and Northstar-3 studies. For more information about the ongoing clinical studies, visit http://www.northstarclinicalstudies.com or clinicaltrials.gov and use identifier NCT02906202 for Northstar-2 (HGB-207), NCT03207009 for Northstar-3 (HGB-212).

About bluebird bio, Inc.bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

Lenti-D and bluebird bio are trademarks of bluebird bio, Inc.

Forward-Looking StatementsThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the companys financial condition, results of operations, as well as statements regarding the plans for regulatory submissions for beti-cel (marketed as ZYTENGLO in the European Union), eli-cel, ide-cel, and LentiGlobin for SCD, including anticipated endpoints to support regulatory submissions and timing expectations; the companys expectations regarding the potential for the suspension manufacturing process for lentiviral vector; its expectations for commercialization efforts for ZYNTEGLO in Europe; as well as the companys intentions regarding the timing for providing further updates on the development and commercialization of ZYNTEGLO and the companys product candidates. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the COVID-19 pandemic and resulting economic conditions will have a greater impact on the companys operations and plans than anticipated; that our amended collaboration with BMS will not continue or be successful; that preliminary positive efficacy and safety results from our prior and ongoing clinical trials will not continue or be repeated in our ongoing or future clinical trials; the risk that our plans for submitting a BLA for LentiGlobin for SCD may be delayed if the FDA does not accept our comparability plans for the use of the suspension manufacturing process for lentiviral vector; the risk that the submission of BLA for ide-cel is not accepted for filing by the FDA or approved in the timeline we expect, or at all; the risk of cessation or delay of any of the ongoing or planned clinical studies and/or our development of our product candidates, including due to delays from the COVID-19 pandemics impact on healthcare systems; the risk that the current or planned clinical trials of our product candidates will be insufficient to support regulatory submissions or marketing approval in the United States and European Union; the risk that regulatory authorities will require additional information regarding our product candidates, resulting in delay to our anticipated timelines for regulatory submissions, including our applications for marketing approval; the risk that we will encounter challenges in the commercial launch of ZYNTEGLO in the European Union, including in managing our complex supply chain for the delivery of drug product, in the adoption of value-based payment models, or in obtaining sufficient coverage or reimbursement for our products; and the risk that any one or more of our product candidates, will not be successfully developed, approved or commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

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bluebird bio to Present New Data from Clinical Studies of elivaldogene autotemcel (eli-cel, Lenti-D) Gene Therapy for Cerebral Adrenoleukodystrophy...

Recommendation and review posted by Bethany Smith

Dear EditorExcellent review and so needed and well-timedThe only issue that did not get the attention it needs are the neuropsychiatric symptoms of mild COVID-19. This is important for medical professionals to know, to avoid labeling the patients' problems as psychiatric and even hysterical as some recently did in a major newspaper here in Belgium.There are two sides to the mental sequelae of mild COVID.a) the consequences of the impact of going through a global pandemic, of lockdown, of COVID patients in their immediate environment, of the fear of infection or infecting others, of losing their job, and finally of their own infection.b) the mental symptoms of an organic disorder.In the subject literature about COIVD-19 (and MERS, SARS and other infections) several mechanisms are mentioned.-A direct neurotropic impact of the virus, especially, but not only via ACE2, both in neurons and glial cells, especially targeting the brain stem which plays a role in emotions. and brought there, among other things, via the direct connection of the olfactory bulb.-Inflammatory and immune reactions that result in cognitive and psychiatric symptoms:(the "misty brain" cited by many patients)-Reactions of the autonomic nervous system, eg cardiac arrhythmias can also be very scary.-Alteration of the gas exchange -oxygen nd carbon dioxide- due to damage to the alveoli resulting in a suboptimal pH.These results in mental symptoms of an organic disorder: memory problems, word finding disorders, confusion, major sleeping problems, insecure motor skills, anorexia, etc. and of course very often chronic fatigue, muscle weakness and anxiety.Of course, fear or anger of the patient are amplified when the doctor labels this as purely psychological, while the patient who has never been ill before, clearly experiences its not.

Because we have only known the disease for six months and we still know so little about it, it is therefore better to take the experiences of the patients seriously, instead of brushing them off as purely psychological or psychiatric.

Here is the original post:
Re: Management of post-acute covid-19 in primary care - The BMJ

Recommendation and review posted by Bethany Smith

Shahid Akhter, editor, ETHealthworld, spoke to. Dr A. Velumani, Promoter, Chairman, Managing Director and Chief Executive Officer, Thyrocare Technologies, to know more about the challenges and opportunities associated with Covid diagnostics business.

Covid-19 : ChallengesBecause of the lockdown, the existing non-covid healthcare and diagnostics business collapsed. It collapsed to 2% suddenly within a week and it didn't allow it to resume for three months.Multiple advisory's multiple tests, whom to test and whom not to, along with plenty of show cause notice because a lot of administrators wanted to under-report positivity and some probably wanted the professional gains, so a lot of time they took in the review. These were the challenges but there were a lot of opportunities as well.

Covid-19: LearningsIn my opinion, Lockdown is not the solution, repeating lockdowns, having every different strict guideline for every different state is not the solution. It won't help to reduce. Secondly, Rapid antigen kits are useless, it doesn't solve anything so we've learned the RT-PCR is the most reliable one in the covid diagnosis.Covid-19: Government's InitiativeAlso, the government labs have contributed significantly which wasn't expected, we were all thinking it is just the private labs who are truly scaling up but government labs too scaled up and contributed more in more than 50% of the testing.

Covid-19: Immunity and antibodyImmunity matters, I don't think lockdown can stop Covid. It is the antibodies that can stop the Covid and India is blessed as only 30% tests are there per million whereas in the US there are 600 tests per million. The antibody power is important to be seen as well if not then there is a problem.

Covid-19: Towards a new normalWork from home will continue, even in healthcare, it is just 17% which is working from home. Also, there will be two different religions in healthcare that will be Covid and Non-Covid so that infection will not pass on to one covid patient to another and non-covid will not move to covid hospitals. The spending on hygiene needs to be high because the general population is scared, medical doctors are scared and the patients are scared.

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RT-PCR is the most reliable test in the covid diagnosis: Dr A. Velumani, CEO, Thyrocare Technologies Ltd. - ETHealthworld.com

Recommendation and review posted by Bethany Smith

London: In a major study, researchers have found that Covid-19 patients with cardiovascular comorbidities or risk factors are more likely to develop heart complications while hospitalised, and more likely to die from the virus.

According to the study, published in the journal PLOS ONE, it is crucial for clinicians working with cardiovascular patients to understand the clinical presentation and risk factors for Covid-19 infection in this group.

"For most people, the Novel Coronavirus Disease 2019 (Covid-19) causes mild illness, however, it can generate severe pneumonia and lead to death in others," said study authors from the Magna Graecia University in Italy.

At the time they were admitted to the hospital, 12.89 per cent of the patients had cardiovascular comorbidities, 36.08 per cent had hypertension and 19.45 per cent had diabetes.

The findings showed that cardiovascular complications were documented during the hospital stay of 14.09 per cent of Covid-19 patients.

According to the researchers, the most common of these complications were arrhythmias or palpitations; significant numbers of patients also had myocardial injury.

Myocardial injury is considered acute if there is a rise and fall of cardiac troponin concentrations exceeding biological and analytical variation.

When the researchers analysed the data, they found that pre-existing cardiovascular comorbidities or risk factors were significant predictors of cardiovascular complications, but age and gender were not.

The study showed that both age and pre-existing cardiovascular comorbidities or risk factors were significant predictors of death.

"Cardiovascular complications are frequent among Covid-19 patients and might contribute to adverse clinical events and mortality," the study author concluded.

Link:
Covid-19 patients with heart problems more likely to die: Study - ETHealthworld.com

Recommendation and review posted by Bethany Smith

Some skin, eggs and tissue samples are all that remain of Malaysia's last rhino, Iman, who died last November after years of failed breeding attempts.

Now scientists are pinning their hopes on experimental stem cell technology to bring back the Malaysian variant of the Sumatran rhinoceros, making use of cells from Iman and two other dead rhinos.

"I'm very confident," molecular biologist Muhammad Lokman Md Isa told Reuters in his laboratory at the International Islamic University of Malaysia.

"If everything is functioning, works well and everybody supports us, it's not impossible."

The smallest among the world's rhinos, the Sumatran species was declared extinct in the wild in Malaysia in 2015. Once it had roamed across Asia, but hunting and forest clearance reduced its numbers to just 80 in neighboringIndonesia.

Iman, 25, died in a nature reserve on Borneo island, following massive blood loss caused by uterine tumors, within six months of the death of Malaysia's last male rhino, Tam.

Efforts to get the two to breed had not worked.

"He was the equivalent of a 70-year-old man, so of course you don't expect the sperm to be all that good," said John Payne of the Borneo Rhino Alliance (BORA), who has campaigned for about four decades to save Malaysia's rhinos.

"It was obvious that, to increase the chances of success, one should get sperm and eggs from the rhinos inIndonesia. But right till today,Indonesiais still not keen on this."

Across the border

Indonesia's environment ministry disputed accusations of cross-border rivalry as a reason why Malaysia's rhinos died out, saying talks continue on ways to work with conservationists in the neighboring southeast Asian nation.

"Because this is part of diplomatic relations, the implementation must be in accordance with the regulation of each country," said Indra Exploitasia, the ministry's director for biodiversity conservation.

The Malaysian scientists plan to use cells from the dead rhinos to produce sperm and eggs that will yield test-tube babies to be implanted into a living animal or a closely related species, such as the horse.

The plan is similar to one for the African northern white rhinoceros, which number just two. Researchers in that effort reported some success in 2018 in producing embryonic stem cells for the southern white rhino.

But the process is still far from producing a whole new animal, say Thomas Hildebrandt and Cesare Galli, the scientists leading the research.

And even if it worked, the animals' lack of genetic diversity could pose a threat to long-term survival, Galli told Reuters.

Indonesian scientist Arief Boediono is among those helping in Malaysia, hoping success will provide lessons to help his country's rhinos.

"It may take five, 10, 20 years, I don't know," Arief added. "But there has already been some success involving lab rats in Japan, so that means there is a chance."

Japanese researchers have grown teeth and organs such as pancreas and kidneys using embryonic stem cells from rats and mice in efforts to grow replacement human organs.

For now, however, Iman's hide will be stuffed and put on display alongside Tam in a Borneo museum.

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Link:
Back from the dead? Stem cells give hope for revival of Malaysia's extinct rhinos - The Jakarta Post - Jakarta Post

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An uncles poignant and loving tribute to his niece after she died following a seven-year battle with Hodgkin Lymphoma has led to life-saving stem cell and bone marrow donations.

Dr Melissa Baker, a single mum of two and forensic pathologist from Melbourne, died on January 16 - just two days after her 45th birthday.

In her memory, Melissas beloved uncle Max Tomlinson placed her photo and information about how to become a stem cell donor on his rear window in the hope of carrying on her hard work.

In memory of my beautiful niece Dr Melissa Baker. You can save a life, dont let Melissas be in vain. Order your swab kit now. Ideally men aged 18 to 45 with diverse backgrounds needed urgently. Order your kit now urthecure.com.au, it reads in white marker pen.

Melissas beloved uncle, Max Tomlinson, placed her photo and information about how to become a stem cell donor on his car's rear window. Source: Facebook

Melissas sister, Jenni Baker, recently posted a picture of Mr Tomlinsons car on Facebook while thanking a member of the public who tucked a yellow flower under his windshield wiper.

Melissa, whos kids are 13 and 8, waited for a bone marrow match for years after an initial six-month round of chemotherapy didnt work, Jenni, a Melbourne police officer, told Yahoo News Australia on Friday.

She underwent a bone marrow transplant using her own stem cells but it almost killed her when she developed a lung infection, her sister said.

Doctors told the 45-year-old, who had since developed cancer of the bone marrow as a result of the chemotherapy, she desperately needed a donor and so she began advocating for UR The Cure.

The volunteer-run charity works with the Australian Bone Marrow Donor Registry (ABMDR) to increase the number of donors especially middle-aged people of diverse backgrounds.

Melissa, whos kids are 13 and 8, waited for a bone marrow match for years after an initial six-month round of chemotherapy didnt work. Source: Facebook

Reluctantly, in November 2019, she underwent a more risky half-match stem cell transplant where I was her donor, Jenni said.

The odds werent great but she had no choice.

Tragically, after 58 days in the hospital, most of which she spent on a ventilator, Melissa died on January 16.

Jennis Facebook post about her uncles tribute has garnered more than 2,500 likes and hundreds of comments, many of which are people who said they had since signed up to be a stem cell donor.

I was a bone marrow donor for my dad. Unfortunately he passed just four months after the donation. I would do it again in a heartbeat for anyone who needed it, one woman wrote.

Beautiful! Tell your uncle I just ordered my kit! another said.

A woman named Amanda also commented, revealing she had been one of Melissas nurses.

I dont know if you remember me. I am one of the nurses who took care of your sister in the ICU. I always admired how much support Melissa had from you and your sister. Her life is definitely not in vain and the love she had from you all was so strong, she wrote.

Melissa Baker underwent a bone marrow transplant using her own stem cells but it almost killed her when she developed a lung infection. Source: Facebook

Story continues

Jenni said Melissa never thought in her wildest dreams this would happen and had at one point thought the cancer would be a battle she would have to fight throughout her life.

The 47-year-old police officer told Yahoo News Australia Melissa became upset when she was often told she had the good cancer because of Hodgkins higher success rate.

She was so mad about it she even made a blog called I Got the Good Cancer documenting her struggles and treatments.

And then everything bad that could have happened, happened, Jenni said.

Jenni (right) and Melissa (left) are pictured together in front of Parliament House. Source: Facebook

The mum-of-two spent last Christmas intubated and sedated in hospital but was able to squeeze her childrens hands when they came to visit.

Tragically, Jenni said her last words to Melissa before the tubes were placed in her throat.

This is really scary, she told her sister.

By her birthday on January 14, Jenni said doctors had decided it was too cruel and removed the tube.

Fifty-two hours later she passed surrounded by her parents, siblings and children.

Do you have a story tip? Email:newsroomau@yahoonews.com.

You can also follow us onFacebook,InstagramandTwitterand download the Yahoo News app from theApp StoreorGoogle Play.

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Uncles incredible tribute to niece who died from the good cancer' - Yahoo News Australia

Recommendation and review posted by Bethany Smith

DUBLIN--(BUSINESS WIRE)--The "Global Autologous Cell Therapy Market: Growth, Trends and Forecasts (2020-2025)" report has been added to ResearchAndMarkets.com's offering.

The Global Autologous Cell Therapy market is anticipated to grow at a CAGR of 15.9% during the forecast period.

The major factors attributing to the growth of the autologous cell therapy market are the rising incidence of chronic diseases such as autoimmune diseases, cancer, blood disorder, and others.

A rise in the population suffering from chronic diseases is also propelling the demand for market growth. In 2018, as per the AARDA (American Autoimmune Related Diseases Association) statistics, around 50 million Americans have an autoimmune disease, and this number is expected to rise in the future.

As per the CDC (Centers for Disease Control and Prevention) estimates Sickel Cell Disease (SCD) affects around 100,000 Americans annually - and there are few more factors which are playing crucial roles in taking the autologous cell therapy market to the next level, among them one is on-going drug developments for new applications which are expected to further propel the growth of the autologous cell therapy market.

Key Market Trends

Bone Marrow Segment Expected to Hold the Largest Market Share

Bone marrow transplant is a technique for replacing damaged and destroyed cells with new stem cells in the bone marrow. Bone marrow is the most commonly used for autologous cell therapy as it can benefit individuals with a range of cancer (malignant) and non-cancer (benign) diseases and will drive the market during the forecast period.

As per the statistics from Globocan 2018, worldwide 18,078,957 individuals have cancer. Asia remains the leading contributor in the rising incidence of cancer with a reported share of 48.4% followed by Europe, North and Latin America, Africa, and Oceania with a share of 23.4%, 13.2% and 7.8%, 5.8%, and 1.4% respectively.

North America Dominates the Market and is Expected to do Same Over the Forecast Period

North America is expected to dominate the overall autologous cell therapy market, throughout the forecast period. This is owing to factors such as the rising incidence of chronic diseases such as cancer, blood disorder, autoimmune diseases, and other diseases and the availability of advanced healthcare infrastructure among the major factors.

In North America, the United States holds the largest market share owing to the factors such as increasing number of population suffering from cancer and other chronic diseases, along with the rising geriatric population and developments related to stem cell therapy and rising demand for biotechnological practices in the country, is anticipated to further drive the demand in this region.

Competitive Landscape

The autologous cell therapy market is moderately competitive and consists of several major players. In terms of market share, few of the major players are currently dominating the market. And some prominent players are vigorously making acquisitions and joint ventures with the other companies to consolidate their market positions across the globe.

Some of the companies which are currently dominating the market are Vericel Corporation, Pharmicell Co. Inc., Holostem Terapie Avanzate S.r.l., Lineage Cell Therapeutics Inc., and Opexa Therapeutics.

Key Topics Covered

1 INTRODUCTION

1.1 Study Deliverables

1.2 Study Assumptions

1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

4.1 Market Overview

4.2 Market Drivers

4.2.1 Rising Incidence of Chronic Diseases

4.2.2 Emphasis Increasingly on Drug Development for New Applications

4.3 Market Restraints

4.3.1 Systemic Immunological Reactions Possibility

4.3.2 Expensive Practise, Product and High Capital Investment

4.4 Porter's Five Force Analysis

5 MARKET SEGMENTATION

5.1 By Therapy

5.1.1 Autologous Stem Cell Therapy

5.1.2 Autologous Cellular Immunotherapies

5.2 By Application

5.2.1 Oncology

5.2.2 Musculoskeletal Disorder

5.2.3 Blood Disorder

5.2.4 Autoimmune Disease

5.2.5 Others

5.3 By Source

5.3.1 Bone Marrow

5.3.2 Epidermis

5.3.3 Others

5.4 By End User

5.4.1 Hospitals

5.4.2 Research Centers

5.4.3 Others

5.5 Geography

5.5.1 North America

5.5.2 Europe

5.5.3 Asia-Pacific

5.5.4 Middle-East and Africa

5.5.5 South America

6 COMPETITIVE LANDSCAPE

6.1 Company Profiles

6.1.1 Vericel Corporation

6.1.2 Pharmicell Co. Inc.

6.1.3 Holostem Terapie Avanzate S.r.l.

6.1.4 Lineage Cell Therapeutics, Inc.

6.1.5 Opexa Therapeutics

6.1.6 BrainStorm Cell Therapeutics

6.1.7 Sangamo Therapeutics

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

For more information about this report visit https://www.researchandmarkets.com/r/gydkh

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World Autologous Cell Therapy Industry 2020-2025 with Vericel, Pharmicell, Holostem Terapie Avanzate, Lineage Cell Therapeutics and Opexa Therapeutics...

Recommendation and review posted by Bethany Smith

New Jersey, United States,- Verified Market Researchhas recently published an extensive report on the Stem Cell Therapy Market to its ever-expanding research database. The report provides an in-depth analysis of the market size, growth, and share of the Stem Cell Therapy Market and the leading companies associated with it. The report also discusses technologies, product developments, key trends, market drivers and restraints, challenges, and opportunities. It provides an accurate forecast until 2027. The research report is examined and validated by industry professionals and experts.

The report also explores the impact of the COVID-19 pandemic on the segments of the Stem Cell Therapy market and its global scenario. The report analyzes the changing dynamics of the market owing to the pandemic and subsequent regulatory policies and social restrictions. The report also analyses the present and future impact of the pandemic and provides an insight into the post-COVID-19 scenario of the market.

Global Stem Cell Therapy Market was valued at USD 117.66 million in 2019 and is projected to reach USD 255.37 million by 2027, growing at a CAGR of 10.97% from 2020 to 2027.

The report further studies potential alliances such as mergers, acquisitions, joint ventures, product launches, collaborations, and partnerships of the key players and new entrants. The report also studies any development in products, R&D advancements, manufacturing updates, and product research undertaken by the companies.

Leading Key players of Stem Cell Therapy Market are:

Competitive Landscape of the Stem Cell Therapy Market:

The market for the Stem Cell Therapy industry is extremely competitive, with several major players and small scale industries. Adoption of advanced technology and development in production are expected to play a vital role in the growth of the industry. The report also covers their mergers and acquisitions, collaborations, joint ventures, partnerships, product launches, and agreements undertaken in order to gain a substantial market size and a global position.

1.Stem Cell Therapy Market, By Cell Source:

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

2.Stem Cell Therapy Market, By Therapeutic Application:

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

3.Stem Cell Therapy Market, By Type:

Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications

Regional Analysis of Stem Cell Therapy Market:

A brief overview of the regional landscape:

From a geographical perspective, the Stem Cell Therapy Market is partitioned into

North Americao U.S.o Canadao MexicoEuropeo Germanyo UKo Franceo Rest of EuropeAsia Pacifico Chinao Japano Indiao Rest of Asia PacificRest of the World

Key coverage of the report:

Other important inclusions in Stem Cell Therapy Market:

About us:

Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

Contact us:

Mr. Edwyne Fernandes

US: +1 (650)-781-4080UK: +44 (203)-411-9686APAC: +91 (902)-863-5784US Toll-Free: +1 (800)-7821768

Email: [emailprotected]

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Stem Cell Therapy Market Size by Top Companies, Regions, Types and Application, End Users and Forecast to 2027 - Bulletin Line

Recommendation and review posted by Bethany Smith

For many patients with multiple myeloma, a new generation of drugs and drug combinations is producing better outcomes and fewer side effects. In recent months, several novel therapies studied and tested by Dana-Farber scientists have gained approval from the U.S. Food and Drug Administration (FDA) or taken a step toward approval after posting solid results in clinical trials.

The drugs are the fruit of years of research into improving treatment for multiple myeloma, a cancer of white blood cells known as plasma cells in the bone marrow. Many of the new agents are biologically derived made from substances such as proteins and antibodies found in living things and target biological mechanisms in a very specific, targeted fashion. Dana-Farber researchers have played a key role in these efforts.

These are each powerful examples of how next-generation novel therapies translated here at Dana-Farber from bench to bedside are further improving outcomes for our patients, and at a remarkable pace, says Paul G. Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber.

Option for relapsed or refractory (non-responsive) myeloma

Following a Dana-Farber-led clinical trial, the FDA recently approved the novel drug isatuximab in combination with pomalidomide and dexamethasone for adults with relapsed or refractory (non-responsive) myeloma who have received at least two prior therapies, including lenalidomide and drugs known as proteasome inhibitors. The drug went into trials after laboratory work by Dana-Farbers Yu-Tzu Tai, PhD, and Kenneth Anderson, MD, showed it was active against myeloma cells. In the clinical trial, the three-drug combination lowered the risk that the disease would progress by 40%, compared to pomalidome and dexamethasone alone.

A drug that doesnt cause hair loss

Dana-Farber investigators conducted laboratory research and led the first clinical trial of the drug melflufen plus dexamethasone in patients with relapsed or refractory myeloma. Melflufen is a peptide conjugate drug made of a stub of protein, or peptide, joined to a chemotherapy agent and delivers a toxic payload directly to myeloma cells in a selective, time-sparing approach.

Results from an early-phase clinical trial published in Lancet Oncology showed the drug is active in patients with myeloma and is safe at recommended doses. Unlike the previously used standard drug melphalan, it doesnt cause mucositis inflammation of membranes within the digestive tract or hair loss. The results prompted investigators to launch two larger trials, some of whose results are being processed and are due to be published soon.

Drug for patients eligible for stem cell transplant

In a major study published in Blood, Dana-Farber researchers and their associates found that in patients newly diagnosed with myeloma who are eligible for a stem cell transplant, adding the drug daratumumab to the standard three-drug regimen produced more responses, and deeper responses, than in patients receiving the three-drug therapy alone.

Targeting myeloma cells and cell division

Dana-Farber researchers were involved in the development and initial testing of the drug belantamab mafodotin, which has shown considerable promise in clinical trials and has been granted priority review for approval by the FDA.

An antibody conjugate drug consisting of an antibody that specifically targets myeloma cells and an agent that disrupts cell division, its use was informed by a preclinical trial at Dana-Farber involving Yu-Tzu Tai, PhD, and Kenneth Anderson, MD. Balantamab mafodotin was tested in studies led by Paul Richardson, MD, in patients with relapsed or refractory multiple myeloma whose disease continued to worsen after a stem cell transplant, chemotherapy, or other treatment. In the DREAMM-1 and -2 trials, the drug showed strong anti-myeloma activity with manageable side effects.

This article was originally published on August 4, 2020, by Dana-Farber Cancer Institute. It is republished with permission.

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Wave of New Therapies Improve Outcomes for Patients with Multiple Myeloma - Cancer Health Treatment News

Recommendation and review posted by Bethany Smith

New York, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cell Isolation/Cell Separation Market Research Report by Product, by Cell Type, by Cell Source, by Technique, by Application, by End User - Global Forecast to 2025 - Cumulative Impact of COVID-19" - https://www.reportlinker.com/p05913776/?utm_source=GNW

The Global Cell Isolation/Cell Separation Market is expected to grow from USD 6,356.88 Million in 2019 to USD 14,485.68 Million by the end of 2025 at a Compound Annual Growth Rate (CAGR) of 14.71%.

Market Segmentation & Coverage:This research report categorizes the Cell Isolation/Cell Separation to forecast the revenues and analyze the trends in each of the following sub-markets:

Based on Product, the Cell Isolation/Cell Separation Market studied across Consumables and Instruments. The Consumables further studied across Beads, Disposables, and Reagents, Kits, Media, and Sera. The Instruments further studied across Centrifuges, Filtration Systems, Flow Cytometers, and Magnetic-Activated Cell Separator Systems.

Based on Cell Type, the Cell Isolation/Cell Separation Market studied across Animal Cells and Human Cells. The Human Cells further studied across Differentiated Cells and Stem Cells.

Based on Cell Source, the Cell Isolation/Cell Separation Market studied across Adipose Tissue, Bone Marrow, and Cord Blood/Embryonic Stem Cells.

Based on Technique, the Cell Isolation/Cell Separation Market studied across Centrifugation-Based Cell Isolation, Filtration-Based Cell Isolation, and Surface Marker-Based Cell Isolation.

Based on Application, the Cell Isolation/Cell Separation Market studied across Biomolecule Isolation, Cancer Research, In Vitro Diagnostics, Stem Cell Research, and Tissue Regeneration & Regenerative Medicine.

Based on End User, the Cell Isolation/Cell Separation Market studied across Biotechnology & Biopharmaceutical Companies, Hospitals & Diagnostic Laboratories, and Research Laboratories & Institutes.

Based on Geography, the Cell Isolation/Cell Separation Market studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas region surveyed across Argentina, Brazil, Canada, Mexico, and United States. The Asia-Pacific region surveyed across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, South Korea, and Thailand. The Europe, Middle East & Africa region surveyed across France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates, and United Kingdom.

Company Usability Profiles:The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Cell Isolation/Cell Separation Market including Beckman Coulter Inc. (Subsidiary of Danaher Corporation), Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., GE Healthcare, Merck KGaA, Miltenyi Biotec, Pluriselect Life Science Ug (Haftungsbeschrnkt) & Co. Kg, Stemcell Technologies, Inc., Terumo Bct, and Thermo Fisher Scientific, Inc..

FPNV Positioning Matrix:The FPNV Positioning Matrix evaluates and categorizes the vendors in the Cell Isolation/Cell Separation Market on the basis of Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Competitive Strategic Window:The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth.

Cumulative Impact of COVID-19:COVID-19 is an incomparable global public health emergency that has affected almost every industry, so for and, the long-term effects projected to impact the industry growth during the forecast period. Our ongoing research amplifies our research framework to ensure the inclusion of underlaying COVID-19 issues and potential paths forward. The report is delivering insights on COVID-19 considering the changes in consumer behavior and demand, purchasing patterns, re-routing of the supply chain, dynamics of current market forces, and the significant interventions of governments. The updated study provides insights, analysis, estimations, and forecast, considering the COVID-19 impact on the market.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on the market offered by the key players2. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments

The report answers questions such as:1. What is the market size and forecast of the Global Cell Isolation/Cell Separation Market?2. What are the inhibiting factors and impact of COVID-19 shaping the Global Cell Isolation/Cell Separation Market during the forecast period?3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Cell Isolation/Cell Separation Market?4. What is the competitive strategic window for opportunities in the Global Cell Isolation/Cell Separation Market?5. What are the technology trends and regulatory frameworks in the Global Cell Isolation/Cell Separation Market?6. What are the modes and strategic moves considered suitable for entering the Global Cell Isolation/Cell Separation Market?Read the full report: https://www.reportlinker.com/p05913776/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Cell Isolation/Cell Separation Market Research Report by Product, by Cell Type, by Cell Source, by Technique, by Application, by End User - Global...

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Use of a novel anti-CD30 CAR T-cell therapy following treatment with fludarabine-based lymphodepletion induced a high rate of durable responses in patients with heavily pretreated relapsed or refractory Hodgkin lymphoma, according to data published in Journal of Clinical Oncology.

Results from the parallel phase 1 and phase 2 studies also demonstrated that the CAR T-cell therapy was safe and did not produce any serious or severe side effects.

Researchers from the UNC Lineberger Comprehensive Cancer Center and Baylor College of Medicine administered anti-CD30 CAR T cells to 41 patients with relapsed or refractory Hodgkin lymphoma. All patients underwent lymphodepletion with bendamustine alone, bendamustine and fludarabine, or cyclophosphamide and fludarabine prior to the anti-CD30 CAR T-cell therapy.

Measuring safety was the primary goal of the two parallel studies.

The overall response rate, or the percentage of partial or complete responses to therapy, among 37 evaluable patients was 62%. Thirty-four of the patients received fludarabine-based lymphodepletion 17 of which received it with bendamustine, and the other half received it with cyclophosphamide. Two of these patients were considered to be complete response at infusion and maintained the response, so they were not included in final analysis.

The overall response rate among the remaining patients was 72%, with 59% of patients achieving a complete response. After a median follow-up of 533 days, researchers identified the one-year progression free survival rate to be 36% and the one-year overall survival rate to be 94%.

This is particularly exciting because the majority of these patients had lymphomas that had not responded well to other powerful new therapies, said senior study author Dr. Barbara Savoldo, professor in the Department of Microbiology and Immunology at the UNC School of Medicine, in a press release.

Patients within the study had received a median of seven previous lines of therapy that included checkpoint inhibitors and autologous or allogeneic stem cell therapies, therapies known to be powerful but also tend to come with a host of side effects.

However, treatment with the anti-CD30 CART cells demonstrated a favorable safety profile. Although 10 patients developed cytokine release syndrome, all cases were considered minor.

Patients who received fludarabine-containing lymphodepletion were the only participants in the study to have a response to the anti-CD30 CAR T-cell therapy.

Although CD30 CAR T (cells) showed modest activity in (Hodgkin lymphoma) when infused without lymphodepletion, robust clinical responses were achieved when these cells were infused in hosts lymphodepleted with fludarabine-containing regimens, the authors wrote.

The activity of this new therapy is quite remarkable and while we need to confirm these findings in a larger study, this treatment potentially offers a new approach for patients who currently have very limited options to treat their cancer, said Dr. Jonathan Serody, director of the bone marrow transplant and cellular therapy program at UNC Lineberger Comprehensive Cancer Center, in the release. Additionally, unlike other CAR T-cell therapies, clinical success was not associated with significant complications from therapy. This means this treatment should be available to patients in a clinic setting and would not require patients to be hospitalized, which is critical in our current environment.

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Novel CAR T-Cell Therapy Shows Promise in Advanced Hodgkin Lymphoma - Curetoday.com

Recommendation and review posted by Bethany Smith

INTRODUCTION

In recent years, a number of growth factors have been tested in clinical trials for a variety of therapeutic applications including bone regeneration and neovascularization of ischemic tissues. Despite early promising results, the results obtained in larger phase 2 trials have often not shown the expected benefit to patients (1, 2), with some having marked adverse effects (35). The Infuse bone graft, which consists of recombinant human bone morphogenetic protein-2 (rhBMP-2) soaked onto a collagen sponge at a dosage of 1.5 mg/ml, has received Food and Drug Administration approval for certain spinal, dental, and trauma indications and is in widespread clinical use. However, major complications and adverse effects have increasingly been attributed because of the off-label use of the product (3, 4). Clinically, the current delivery vehicle for BMP-2 is a collagen powder or sponge that has been shown to result in a large initial burst release, which contrasts with the expression profile observed during normal fracture repair where BMP expression increases until day 21, suggesting a need for slower and more sustained growth factor release profile (6, 7). Furthermore, because of the short half-life of the growth factor and the harsh fracture environment (5), supraphysiological dosages of BMP-2 are being delivered to elicit bone regeneration, which has been linked to adverse effects such as heterotopic ossification. Therefore, there is a clear clinical need to develop alternative strategies to deliver single or multiple growth factors to the site of injury with sustainable and physiologically relevant dosages such that repair is induced without these adverse effects.

A number of growth factors have been shown to be expressed at different phases of fracture healing, including vascular endothelial growth factor (VEGF) and BMPs. The coupled relationship in bone healing, both physical and biochemical, between blood vessels and bone cells has long been recognized (8, 9). During fracture healing, VEGF is released directly after injury and predominately drives the formation of the fracture hematoma (9). Inhibition of VEGF has been shown to disrupt the repair of fractures and large bone defects (1012). Despite this, VEGF delivery alone is often not sufficient to heal critically sized bone defects, which may be due to suboptimal dosing or the timing of VEGF release. Furthermore, VEGF does not appear to drive progenitor cell differentiation toward the chondrogenic or osteogenic lineage; therefore, combination therapies with BMPs have been developed in an attempt to accelerate the regeneration of large bone defects (9, 1318). During normal fracture healing, VEGF expression peaks around day 5/10 (19, 20) and then decreases, whereas BMP-2 expression increases constantly until day 21, suggesting a need for delivery systems that support the early release of VEGF and the sustained release of BMP-2 (6, 7, 19, 20). To this end, composite polymer systems have been used to deliver VEGF and BMP-2 in a sequential fashion (1518). The timed release of VEGF/BMP-2 was found to enhance ectopic bone formation (1618); however, in an orthotopic defect, no significant benefit was observed (17, 18). This may be due to the high dose of VEGF used in these studies (18), which has previously been shown to disrupt osteogenesis as a result of abnormal angiogenesis and vascular structure (8), or due to suboptimal growth factor release profiles from these constructs. This suggests that novel strategies are required for delivering low-dosage VEGF and BMP-2, with tight temporal control, to enhance vascularization and subsequent bone formation in orthotopic defects. Nanoparticles such as hydroxyapatite (HA) and laponite are known to be osteoinductive and have previously been shown to facilitate the adsorption and immobilization of proteins such as VEGF and BMP-2 because of the strong attraction between the nanoparticles and the growth factor (2123). This motivates the integration of these nanoparticles into regenerative implants to enable tight temporal control over the rate at which encapsulated growth factors are released into damaged tissue.

Processes such as angiogenesis are regulated not only by the temporal presentation of growth factors but also by spatial gradients of morphogens that regulate chemotactic cell migration. Using microfluidic devices (24, 25) or three-dimensional (3D) culture models (26, 27), it has been demonstrated that endothelial cell migration is mediated by gradients in VEGF. However, it is unclear whether incorporating gradients of VEGF into tissue-engineered scaffolds will enhance angiogenesis in vivo. Here, we used emerging multiple-tool biofabrication techniques (28) to deliver VEGF and BMP-2 with distinct spatiotemporal release profiles to enhance the regeneration of critically sized bone defects. To tune the temporal release of these morphogens from 3D printed constructs, we functionalized alginate-based bioinks with different nanoparticles known to bind these regulatory factors. Both the spatial position and temporal release of growth factor from the 3D printed implant determined its therapeutic potential. By slowing the release of BMP-2, it was possible to enhance bone formation in vivo within predefined positions of the implant. Furthermore, introducing spatial gradients of VEGF into 3D printed implants enhanced vascularization in vivo compared to controls homogenously loaded with the same total amount of growth factor. We also demonstrate accelerated large bone defect healing, with minimal ectopic bone formation, using 3D printed implants containing a spatial gradient of VEGF and spatially localized BMP-2.

To produce a printable bioink, various weight concentrations of methylcellulose were first added to RGD -irradiated alginate. Print fidelity (as measured by the filament spreading ratio) improved by increasing the methylcellulose content [see fig. S1 (A and B)]; however, the capacity to print multiple layers of material worsens because of the overly adhesive nature of the ink. For these reasons, a weight concentration of 2:1 (w/w) alginate to methylcellulose was chosen for all bioinks, as it substantially increased the print fidelity while allowing multiple layers of material to be accurately deposited.

To tune the temporal release profile of growth factor (here, VEGF), clay nanoparticles (22, 23, 29) or hydroxyapatite nanoparticles (nHA) (21) were added to the alginate-methylcellulose bioink. Adding methylcellulose to the alginate to produce a printable ink significantly increased the release of VEGF compared to that observed from alginate only [see fig. S1 (C and D)]. The addition of laponite, a clay-based nanoparticle, markedly slowed the release of VEGF (see fig. S1C), while the incorporation of nHA only had a small effect on growth factor release, producing a slightly more gradual release profile (see fig. S1D). This blend (alginate, methylcellulose, and nHA) will hereafter be referred to as the vascular bioink, as it allowed for the near complete release of VEGF over 10 days, mimicking that observed during normal fracture healing (19, 20). No laponite was included in this vascular bioink.

To demonstrate the utility of this vascular bioink, two strategies were compared to print implants containing a spatial gradient of VEGF (see fig. S1E). In the first, VEGF (100 ng/ml) was printed into the central 5-mm core of constructs 8 mm in diameter and 4 mm high, with a VEGF-free bioink used to print the periphery of the construct. In the second, VEGF (80 ng/ml) was printed into the center of the construct, and VEGF (20 ng/ml) was printed around the periphery of the implant. Control constructs containing a homogenous distribution of VEGF were also printed. One hour after printing, clear spatial differences in VEGF localization were observed in both gradient constructs, while roughly the same amount of protein was detected in the core and periphery of the homogenous VEGF control (see fig. S1F). Fourteen days after printing, a spatial gradient still existed in the construct that initially had all VEGF loaded into its central region, with no gradient observed in the other groups (see fig. S1G). This demonstrates that spatial gradients of growth factor can be maintained within constructs for at least 14 days after printing.

We next sought to assess whether depositing spatial gradients of VEGF within 3D printed polycaprolactone (PCL) implants would accelerate vascularization of the constructs in vivo. To this end, Homogenous VEGF, Gradient VEGF, and No VEGF constructs were implanted subcutaneously in the back of mice (see Fig. 1A), where the total amount of growth factor (25 ng) within the two VEGF-containing implants was constant. Two weeks after implantation, histological analysis of hematoxylin and eosin (H&E)stained samples revealed the presence of vessels in the Homogenous VEGF and Gradient VEGF groups; however, there were no obvious vessels present in the No VEGF group (see Fig. 1B). These vessels appeared mature, complete with smooth muscle actin (-SMA) and von Willebrand factor (vWF)stained walls and perfused with erythrocytes (see fig. S2A). The Homogenous VEGF constructs had vessels predominantly located in the periphery of the scaffold, with little to none present within the center of the scaffold. On the other hand, vessels were present both in the periphery and in the center of the Gradient VEGF group. Four weeks after implantation, all three experimental groups had mature vessels present (see Fig. 1C and fig. S2B). Similar to the Homogeneous VEGF group, the No VEGF group had vessels predominantly located in the periphery of the constructs, with little to none present within the center of the construct. When quantified, at both 2 and 4 weeks, there were significantly more vessels present in the Gradient VEGF group compared to both the Homogenous VEGF and No VEGF group (see Fig. 1D). There was significantly more vessels present in the periphery of the Gradient VEGF constructs at both 2 and 4 weeks in vivo compared to the other two experimental groups [see Fig. 1 (E and F)]. There was also a trend toward a larger number of vessels present in the center of the Gradient VEGF construct at 4 weeks compared to No VEGF (P = 0.09) and Homogenous VEGF (P = 0.1) groups (see Fig. 1F).

(A) Schematic of the 3D printed scaffold and experimental groups. Construct design (4 mm in diameter, 5 mm in height). H&E-stained sections of the three experimental groups at (B) 2 and (C) 4 weeks in vivo. Images were taken at 20. Arrows denote vessels. (D) Total number of vessels of the experimental groups at 2 and 4 weeks in vivo. Number of vessels present in the center versus the periphery at (E) 2 and (F) 4 weeks in vivo. **P < 0.01. Error bars denote SDs (n = 8 animals; n = 5 slices per animal). FBS, fetal bovine serum; pen/strep, penicillin/streptomycin.

Recognizing that a slower and more sustained release of BMP-2 could be beneficial for promoting osteogenesis (6, 7), we next sought to compare bone formation in vivo within implants with temporally distinct growth factor release profiles. To the base alginate-methylcellulose bioink (here termed the Fast BMP-2 Release bioink), laponite at varying w/w ratios of laponite to alginate were compared to determine the optimum ratio to generate a Slow BMP-2 Release bioink (see fig. S3). As there was little difference in the growth factor release profile from the different groups, a 6:1 alginate:laponite w/w ratio was chosen to minimize the amount of laponite in the bioink. The addition of laponite markedly slowed the in vitro release of BMP-2 from the bioink, resulting in a reasonable constant release of growth factor from day 7 to day 35 (see Fig. 2C). The addition of laponite also had no significant effect on the degradation rate of the bioink (Fig. 2B).

(A) Schematic of the experimental groups. Construct design (4 mm in diameter, 5 mm in height). MEM, alpha minimum essential medium. (B) Degradation of the two bioinks. (C) Cumulative release of BMP-2 of the fast release bioink versus the slow release bioink. (D) 3D reconstructions of the CT data for each group at 8 weeks. (E) CT analysis on total mineral deposition of each of the groups after 8 weeks in vivo. (F) CT analysis on the location of mineral deposition of each of the groups after 8 weeks in vivo. ***P < 0.001; error bars denote SDs (n = 8 animals). (G) Goldners trichromestained sections of both groups after 8 weeks in vivo. Images were taken at 20. White arrows denote developing bone tissue, and black arrows denote blood vessels. (H) Quantification of the amount of new bone formation per total area. Error bars denote SDs; **P < 0.01 (n = 8 animals, n = 6 slices per animal).

To assess whether slow and sustained release of BMP-2 would enhance ectopic bone formation in vivo, Fast BMP-2 Release (laponite) and Slow BMP-2 Release (+laponite) bioinks were mixed with bone marrowderived mesenchymal stem cells (BMSCs), deposited within 3D printed scaffolds, and then implanted subcutaneously in the back of mice (see Fig. 2A). Seeding these bioinks with MSCs was used to test their potential for promoting osteogenesis in an ectopic location. BMP-2 was specifically localized around the periphery of the implant. This pattern of growth factor presentation was chosen to test the capacity of the printed implants to spatially localize bone formation in vivo (note that the geometry of the implant is the same as that which will be used in the segmental defect study below, with the BMP-2 localized to the periphery of the implant such that bone would only form along the cortical shaft of the damaged limb rather than throughout). Eight weeks after implantation, there was significantly more mineral within the Slow BMP-2 Release group compared to the Fast BMP-2 Release group [see Fig. 2 (D and E)]. Microcomputed tomography (CT) reconstructions revealed that the mineral was preferentially deposited around the periphery of the constructs where the BMP-2 was localized [see Fig. 2 (D and F)]. Histological staining further verified this finding, with positive staining for new bone seen predominantly in the periphery of both groups (see Fig. 2G, denoted by white arrows). Quantification revealed that the Slow BMP-2 Release constructs had significantly more new bone formation per total area of construct (see Fig. 2H).

We next sought to assess whether the delayed release of BMP-2 from printed constructs containing spatial gradients in VEGF would enhance angiogenesis and bone formation within critically sized bone defects. To this end, VEGF gradient only, BMP-2 gradient only, and Composite (VEGF+BMP-2 gradient) constructs were printed and implanted in a 5-mm rat femoral defect (see Fig. 3A) and compared to an empty defect.

(A) Schematic of the 3D printed experimental groups including key features of the developed bioinks and the segmental defect procedure. Construct design (4 mm in diameter, 5 mm in height). (B) CT angiography representative images of vessel diameter. Red arrows denote leaky blood vessels denoted by pools of contrast agent. Quantification on (C) total vessel volume, (D) average vessel diameter, and (E) connectivity for all groups after 2 weeks in vivo. *P < 0.05 and **P < 0.01; error bars denote SDs (n = 9 animals). (F) Immunohistochemical staining of nuclei (blue), vWF (red), and SMA (green) of the experimental groups at 2 weeks after implantation. Images were taken at 40 and 63. Yellow arrows denote vessels with SMA and vWF dual staining; white arrows denote slightly less mature vessels with only vWF positive staining.

Two weeks after implantation, CT angiography was used to quantify and visualize the early vascular network that had formed within the defect site. 3D reconstructions revealed that vascular networks had formed in all four experimental groups (see Fig. 3B). When quantified, there was a significant increase in vessel volume in the Composite group compared to the VEGF gradient group (see Fig. 3C). There was also a significant increase in average vessel thickness in the BMP-2 gradient and Composite groups compared to the VEGF gradient group (see Fig. 3D). Although there was no significant difference in the connectivity of the vessels, there was a trend (P = 0.1) toward increased connectivity in the Composite group compared to the VEGF gradient group (see Fig. 3E). 3D reconstructions also revealed the presence of primitive immature blood vessels depicted by large globules of contrast agent (denoted by the red arrows in Fig. 3B). There appeared to be fewer primitive blood vessels present in the Composite group than the other three experimental groups. This was further verified by SMA and vWF staining, which revealed a larger number of vessels with only positive vWF-stained walls in the Empty and VEGF gradient groups (see Fig. 3F, denoted by white arrows). On the other hand, there were predominately more mature vessels with SMA and vWF-stained walls in both the BMP-2 gradient and Composite groups (see Fig. 3F, denoted by yellow arrows). Note that the differences in angiogenesis seen between the VEGF gradient and Composite groups (same amount of VEGF in both groups) could at least partially be explained by looking at the VEGF release profile from both groups (see fig. S4). The addition of the osteoinductive ink around the implant periphery significantly reduced the VEGF release rate from construct into the media, with a more linear release of growth factor over time.

Two weeks after surgery, defects within the Empty group were filled with a fibrous tissue (see Fig. 4A). In contrast, positive staining for cartilage and new bone deposition was observed in the BMP-2 gradient and Composite groups, suggesting that new bone was forming at least partially via endochondral ossification. When quantified, there was a trend toward increased cartilage development (red staining in Safranin O images) in both the BMP-2 gradient (P = 0.12) and Composite (P = 0.18) groups compared to the Empty (see Fig. 4B). No significant differences in bone formation was observed between any of the groups at week 2; however, the CT reconstructions showed mineralized calluses beginning to form in the BMP-2 gradient and Composite groups, which was less evident in the Empty and VEGF gradient groups [see Fig. 4 (C and D)].

(A) H&E- and Safranin Ostained sections of all groups after 2 weeks in vivo. Images were taken at 20. DB denotes cartilage undergoing endochondral ossification to become developing bone, and B denotes positive new bone tissue. Quantification of the amount of (B) bone formation and (C) developing bone per total area. Error bars denote SDs (n = 9 animals). (D) CT reconstructed images of the defect site.

Next, CT analysis was used to visualize and quantify bone formation within the defects at 4, 8, 10, and 12 weeks after implantation. Compared to the Empty group, there were significantly higher levels of new bone formation in the Composite group as early as 8 weeks after implantation [see Fig. 5 (A and B)]. A consistent pattern of healing was observed in the Composite group, with bone forming down through the PCL scaffold framework (see Fig. 5A and fig. S5). After 10 weeks of implantation, significantly higher levels of bone formation was observed in the BMP-2 gradient and Composite groups compared to the Empty group. By 12 weeks, all three experimental groups contained significantly higher levels of new bone compared to the Empty group. Twelve weeks after implantation, bone density mapping revealed that the new bone formed in the experimental groups consisted of a dense cortical-like bone present around the periphery of defect, comparable to the adjacent native bone (1200 mg HA/cm3) (see Fig. 5C). Quantitative densitometry analysis revealed no significant difference in the average density (mg HA/cm3) of the new bone that did form between any of the groups over the 12 weeks (see Fig. 5D).

(A) Reconstructed in vivo CT analysis of bone formation in the defects. (B) Quantification of total bone volume (mm3) in the defects at each time point. (C) Representative images of CT bone densities in the defects at 12 weeks halfway through the defect (scale bar, 1 mm throughout). (D) Average bone density (mg HA/cm3) in the defects at each time point. (E) Outline of ROI bone volume analysis including definitions of core, annulus, and heterotopic regions. (F) Total bone volume (mm3) in each region at 12 weeks. **P < 0.01, ***P < 0.001, and ****P < 0.0001; error bars denote SDs (n = 9 animals).

To assess the levels of heterotopic bone formation, region of interest (ROI) bone volume analysis was performed on the week 12 reconstructions. The total bone volume was quantified in the core, annulus, and heterotopic regions of the defect (see Fig. 5E). In all three experimental groups, bone preferentially formed in the annulus of the defect, with little ectopic bone formation (see Fig. 5F). All three experimental groups had significantly higher total bone volume in the annulus of the defect compared to the Empty annulus, with the highest total bone volume present in the Composite group.

We next sought to assess the nature of new bone tissue being formed using histological staining. Goldners trichrome staining revealed predominantly fibrous tissue formation, similar to what was seen previously at 2 weeks, in the Empty group (see Fig. 6A). There was positive staining for new bone, complete with marrow cavities, in all three experimental groups at 12 weeks after implantation. When quantified, there was significantly more bone found in all three experimental groups compared to the Empty group (see Fig. 6B). There were also significantly higher amounts of bone marrow present in the Composite group compared to the Empty group (see Fig. 6C). As observed in the CT 3D reconstructions, it is clear that the bone is forming down through the PCL scaffold framework, specifically in the Composite group. Safranin O staining revealed the presence of cartilage in all three experimental groups after 12 weeks, demonstrating that bone is continuing to develop via endochondral ossification. When quantified, there was significantly more cartilage present in the Composite group compared to all other groups at this time point (see Fig. 6D).

(A) Goldners trichrome and Safranin Ostained sections of all groups after 12 weeks in vivo. Images were taken at 20. BM denotes bone marrow. PCL denotes areas where the PCL frame was. DB denotes cartilage undergoing endochondral ossification to become new bone, and B denotes positive bone tissue. Quantification of the amount of (B) bone formation, (C) bone marrow, and (D) developing bone per total area. Error bars denote SDs. *P < 0.05, **P < 0.01, and ****P < 0.0001 (n = 9 animals).

Despite the tremendous potential of growth factor delivery, the results obtained in larger clinical trials have not always shown the expected benefit to patients (2), with some studies reporting marked adverse effects (35). The reasons for this are multifaceted, from the delivery methods to the supraphysiological dosages needed to elicit a therapeutic effect and the costs and adverse effects attached to these high doses. This study presents a novel alternative approach for spatiotemporally controlled delivery of growth factors. We developed a range of nanoparticle-functionalized bioinks to precisely control the temporal release of growth factors from 3D printed implants. Using multiple tool biofabrication techniques, we were able to print constructs containing spatiotemporal gradients of growth factors, which allowed for controlled tissue regeneration without the need for supraphysiological dosages. Specifically, the appropriate patterning of VEGF enhanced angiogenesis in vivo and, when coupled with defined BMP-2 localization and release kinetics, enhanced large bone defect healing with little heterotopic bone formation.

Alginate hydrogels are commonly used for bone tissue engineering, with a number of studies demonstrating the bone regeneration potential of RGD functionalized and -irradiated alginate (3033), making it a promising base bioink for the 3D bioprinting of osteogenic implants. However, one drawback to using RGD -irradiated alginate as a bioink is its low viscosity. It is imperative when printing multilayered structures that the bioink have appropriate rheological properties to prevent collapsing or sagging of the printed structure. The addition of methylcellulose to alginate-based bioinks was found to have a significant effect on both printability and the rate of growth factor release. The addition of methylcellulose has previously been shown to substantially increase the print fidelity of an alginate base bioink (22, 34, 35), although typically using higher concentrations than the one used in this study. Adding methylcellulose also accelerated the rate of growth factor release. This was previously seen with albumin release from alginate-methylcellulose beads (36). Such a polymeric network is at least partially defined by physical entanglements between the alginate or methylcellulose chains. As methylcellulose is characterized by high swellability, when the alginate/methylcellulose bioink is exposed to the medium, it swells rapidly, resulting in accelerated growth factor release from the bioink. The addition of methylcellulose may also have neutralized the charge on the alginate, which would also influence growth factor release kinetics. In contrast, the addition of nanoparticles, and, in particular, laponite, slowed the release of growth factor from the inks. Both nHA and laponite have previously been shown to facilitate with the adsorption and immobilization of VEGF within a hydrogel due to the strong attraction between the nanoparticles and the growth factor (2123). The stronger association between growth factors and laponite can be linked to the physiochemical properties of these particles (22, 29). These disc-shaped particles [typically 25 nm in diameter and 1 nm in thickness (37)] are characterized by a highly negatively charged face and a positively charged rim (22), with a zeta potential of 61 mV (as determined by the manufacturer). This allowed the positively charged growth factors such as VEGF to form strong electrostatic bonds with the negatively charged face of the nanoparticles (22). In contrast, the nHA nanoparticles used in this study, which we have previously shown to have a zeta potential of around 5 mV (38), would form a slightly weaker electrostatic bond with the VEGF. The addition of laponite to bioinks has also previously been shown to influence their mechanical properties (37). While we did not directly assess whether the addition of laponite influenced the stiffness of our ink, we did observe that it had no effect on their degradability, and on the basis of w/w ratio used in this study, we do not believe it had marked effects on mechanical properties such as matrix stiffness. Previous studies have shown that when using high concentrations of alginate (similar to that used in this study), the addition of laponite does not markedly affect the rheological properties of the bioink (37). However, future studies should investigate the overall mechanical properties of a bioink, as this may also influence its osteogenic potential (39). A potential limitation of laponite is that the strong electrostatic bond can limit the amount of growth factor released from a delivery system in the short-medium term (22). In this study, by tuning the ratio of laponite to alginate, it was possible to engineer bioinks that released most of their loaded protein over 35 days. Therefore, using specifically selected nanoparticles, it is possible to develop bioinks that support growth factor release profiles spanning days to weeks.

Using multiple-tool biofabrication, we demonstrated that distinct growth factor gradients can be established and maintained over time and that incorporating these gradients into printed implants can enhance sprouting angiogenesis in vivo. The process of sprouting angiogenesis begins with the selection of a distinct site on the mother vessel where sprout formation is initiated. This distinct site is referred to as the tip cell, and as the new sprout elongates, branches, and connects with other sprouts, the selection process for the tip cell is constantly reiterated (40). Previous studies have shown in the early postnatal retinas that tip cell migration depends on a gradient of VEGF-A and its proliferation is regulated by its concentration (40, 41). Therefore, the increase in vessel infiltration observed in VEGF gradient implants can possibly be attributed to tip cell migration and proliferation toward the areas of high VEGF concentration (40, 41). In contrast, when VEGF was homogenously distributed within the implant, there was less of a chemotactic effect, resulting in lower levels of vessel infiltration into the center of the construct.

When this bioprinting strategy was used to deliver both growth factors within a large bone defect, there was a significant increase in vessel infiltration within implants containing both a VEGF gradient and BMP-2 compared to those containing VEGF alone. Although it has been shown that delivery of BMP-2 alone can enhance new blood vessel formation within bone defects (42, 43), previous studies have not reported a benefit to delivering both growth factors to the defect site (17, 18). The finding that the laponite-functionalized bioink around the periphery of the implant was slowing the release of VEGF from the implant may partially explain the higher levels of vessel infiltration observed within the composite implant, with the slower VEGF release profile being perhaps more conducive to angiogenesis within the orthotopic environment. Somewhat unexpectedly, despite enhancing overall levels of bone formation, VEGF delivery alone did not increase early vessel infiltration into the implant. Note that orthotopic hematomas, generated by the surgical procedure, would have provided all defects with a source of endogenous chemotactic, angiogenic, and mitogenic growth factors (17). This may have mitigated the effect that an implant containing a VEGF gradient alone had on early angiogenesis.

3D printed implants containing spatial gradients of VEGF, coupled with defined BMP-2 localization, enhanced large bone defect healing with little heterotopic bone formation. Critically, this increase in bone healing was achieved using very low concentrations of exogenous growth factors. The concentration of VEGF used in this study was substantially less (80 to 160 times less) than previous studies (17, 18). Achieving therapeutic benefits with these low concentrations of growth factors is important for multiple reasons, not least of which is the observation that high concentrations of VEGF have been previously shown to disrupt osteogenesis as the result of abnormal angiogenesis and vascular structure (8). Furthermore, the concentrations of BMP-2 used here are at least an order of magnitude lower than that used previously to repair similar sized defects in a rat femoral defect model (28, 31). Repair in these studies is typically associated with a substantial amount of heterotopic bone formation (28, 31). Directly comparing to previous work in our lab, which used a clinically relevant BMP-2 dose in the same defect model (28), the results from this study exhibited substantially less heterotrophic bone formation [10% versus 50% (28) of total bone volume]. Although we did not observe full bone bridging after 12 weeks, new bone was still being formed via the process of endochondral ossification at 12 weeks, suggesting that regeneration was still proceeding. Allowing some level of physiological loading earlier in the healing process would likely have further accelerated regeneration (44). Together, the results from this study demonstrate the potential of 3D printing morphogen gradients for controlled tissue regeneration (with minimal heterotopic bone formation) without the need of supraphysiological dosages.

The translation of tissue engineering concepts from bench to bedside is a challenging, expensive, and time-consuming process. Numerous products have not made it past phase 2 trials, as they have not shown the expected benefit in patients (1, 2), while others have been associated with marked adverse effects (35). Here, we describe a previously unidentified approach for spatiotemporally defined growth factor delivery and demonstrate a potential clinical utility in the regeneration of large bone defects or the increased vascularization of any 3D printed construct. Proof-of-concept studies in small animals established the potential of these growth factor loaded bioinks for inducing enhanced angiogenesis and bone regeneration without the need for supraphysiological dosages. The benefit of this precise localization of growth factors in both time and space is that it allows for tightly controlled angiogenesis and new tissue formation, thereby reducing off-target effects. It is envisioned that this platform technology could be applied to the controlled regeneration of numerous different tissue types.

This study was designed to test whether the delayed release of BMP-2 from bioprinted constructs containing spatial gradients in VEGF will first enhance vascularization and sequentially enhance orthotopic bone regeneration. All animal experiments were conducted in accordance with the recommendations and guidelines of The Health Products Regulatory Authority, the competent authority in Ireland responsible for the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes in accordance with the requirements of the Statutory Instrument no. 543 of 2012. Subcutaneous mouse experiments were carried out under license (AE 19136/P069), and the rat femoral defect experiments were carried out under license (AE19136/P087) approved by The Health Products Regulatory Authority and in accordance with protocols approved by the Trinity College Dublin Animal Research Ethics Committee. The n for rodent models were based on the predicted variance in the model and was powered to detect 0.05 significance. For the subcutaneous surgeries, constructs were implanted in a balanced manner, such that each group contained an implant placed at each of the subcutaneous locations and samples for both surgical procedures were randomly distributed across the operated animals. For the rat surgeries, three rats from the empty group died from unforeseen complications and so were removed from the n number at the 12-week time point. One rat from the BMP-2 gradient group at 12-week time point was also removed, as it was deemed a statistical outlier using the Grubbs test.

Lowmolecular weight sodium alginate (58,000 g/mol) was prepared by irradiating sodium alginate (196, 000 g/mol; Protanal LF 20/40, Pronova Biopolymers, Oslo, Norway) at a gamma dose of 50,000 gray, as previously described (45). RGD-modified alginate was prepared by coupling the GGGGRGDSP to the alginate using standard carbodiimide chemistry. All bioinks were prepared by dissolving the RGD -irradiated alginate in growth medium, which consisted of alpha minimum essential medium (MEM) (GlutaMAX; Gibco, Biosciences, Ireland), 10% fetal bovine serum (FBS) (EU Thermo Fisher Scientific), penicillin (100 U/ml; Sigma-Aldrich), and streptomycin (100 g/ml; Sigma-Aldrich) (pen-strep) to make up a final concentration of 3.5% (w/v).

3D bioplotter from RegenHU (3DDiscovery) was used to evaluate the printability of the generated bioinks. The printability of varying the w/w ratio (2:1, 1:1, and 1:2) of methylcellulose to alginate was evaluated by measuring the spreading ratio as previously described (39)Spreading Ratio=Printed Filament DiameterActual Needle Diameter

To establish whether increasing the viscosity of the bioink influences growth factor release, methylcellulose (Sigma-Aldrich) was also added at ratio of 1:2 (w/w) to a 3.5% alginate solution of RGD -irradiated alginate. To establish whether the addition of clay-based particles to the bioink could further tailor the growth factor release profile of the bioinks, a 3.5% RGD -irradiated alginate solution was made, and either methylcellulose (2:1) (w/w) or a combination of both methylcellulose and laponite (Laponite XLG, BYK Additives & Instruments, UK) (6:3:1) (w/w) was added.

To establish whether the addition of nHA to the alginate would facilitate the adsorption and immobilization of growth factors within the hydrogel due to their strong electrostatic attraction between nHAs, three bioinks were tested (21). nHAs were prepared following a previously described protocol (46). A 3.5% RGD -irradiated alginate solution was made, and either methylcellulose (1:2) (w/w) or a combination of methylcellulose and nHA (2:1:2) (w/w) particles was added.

For all the growth factor release studies, VEGF (100 ng/ml; Gibco Life Technologies, Gaithersburg, MD, USA) was added to the solutions using dual-syringe approach, before precross-linking with 60 mM CaSO4 to make the bioinks as previously described (39). All constructs were cultured in growth medium in normoxic conditions, and media from each sample were changed bi-weekly. For VEGF release study, medium samples were taken (days 0, 3, 5, and 10) and snap-frozen at 80C. Hydrogels were also snap-frozen at 80C on day 0 to quantify the concentration of growth factor present in the constructs directly after printing.

To demonstrate the utility of the vascular bioink, two strategies were compared to print implants containing a spatial gradient of VEGF. The vascular bioink was prepared, cross-linked with 60 mM CaSO4, and printed to generate three experimental groups: (i) Homogenous VEGF. Bioink loaded with VEGF (100 ng/ml) was used to print constructs 8 mm in diameter and 4 mm high. (ii) Gradient 1. Bioink loaded with VEGF (100 ng/ml) was used to print a central 5-mm core with a VEGF-free bioink printed around the periphery of the 8-mm-diameter construct. (iii) Gradient 2. VEGF (80 ng/ml) was printed into the core, and VEGF (20 ng/ml) was printed into the periphery. Postprinting constructs were cross-linked again in a bath of 100 mM CaCl2 for 1 min. Constructs were cultured in growth medium in normoxic conditions for 14 days in vitro. The center and periphery of each construct were separated by coring out the center from the periphery of the scaffold and then snap-frozen at 80C, 1 hour after printing, and after 14 days in vitro.

To investigate whether the addition of laponite can tailor the growth factor release profile over a long culture period, a base bioink (Fast BMP-2 Release) and a laponite bioink (Slow BMP-2 Release) were compared. For both growth factor release profiles, a dual-syringe approach was used to deliver BMP-2 (200 ng/ml; PeproTech, UK) to the solutions before precross-linking with 60 mM CaSO4 to make the bioinks. These were printed into a 100 mM CaCl2 soak agarose mold to generate final constructs of 6 mm by 6 mm high. In addition to comparing the growth factor release profile of the two bioinks, the degradation rate of the bioinks was also investigated. These scaffolds were cultured in normoxic conditions for up to 35 days and media from each sample were changed weekly. For BMP-2 release study, medium samples were taken (days 0, 5, 7, 14, 21, and 35) and snap-frozen at 80C. Printed hydrogels were also snap-frozen at 80C on day 0 to quantify the concentration of growth factor present in the constructs directly after printing. For the degradation study, samples were washed and snap-frozen at 80C and each time point (days 0, 5, 7, 14, and 21). Samples were lyophilized by placing the samples in a freeze dryer (FreeZone Triad, Labconco, Kansas City, USA). Each sample was then weighed using an analytical balance (Mettler Toledo, XS205).

An enzyme-linked immunosorbent assay was used to quantify the levels of VEGF and BMP-2 (Bio-Techne, MN, USA) released by the alginates. The alginate samples were depolymerized with 1 ml of citrate buffer (150 mM sodium chloride, 55 mM sodium citrate, and 20 mM EDTA in H2O) for 15 min at 37C. The cell culture media and depolymerized alginate samples were analyzed at the specific time points detailed above. Assays were carried out as per the manufacturers protocol and analyzed on a microplate reader at a wavelength of 450 nm.

BMSCs were obtained from the femur of a 4-month-old porcine donor as previously described (47). All expansion was conducted in normoxic conditions, expanded in growth medium where the medium was changed twice weekly. Cells were used at the end of passage 3.

A 3D bioplotter from RegenHU (3DDiscovery) was used to print all of the scaffolds. Using a 30-gauge needle, constructs of 4 mm 5 mm high with both lateral and horizontal porosity and a fiber spacing of 1.2 mm were printed with PCL (Cappa, Perstop). The printing parameters of the PCL were as follows: temperature of thermopolymer tank (69C), temperature of thermopolymer head (72C), pressure (1 bar), screw speed (30 rpm), and feed rate (3 mm/s). Scaffolds were sterilized using ethylene oxide sterilization before hydrogel printing.

For the VEGF gradient study, the vascular bioink was prepared, cross-linked with 60 mM CaSO4, and printed within the PCL framework to generate three experimental groups: (i) No VEGF, bioink not loaded with VEGF; (ii) Homogenous, bioink loaded with VEGF (100 ng/ml) deposited (25 ng per construct) throughout the construct; and (iii) Gradient, bioink loaded with VEGF (500 ng/ml) deposited in the center (25 ng per construct) and VEGF-free bioink deposited on the outside (see Fig. 1A). Postprinting constructs were cross-linked again in a bath of 100 mM CaCl2 for 1 min.

For the BMP-2 release study, both a fast and slow release bioink were prepared and using the dual syringe approach, porcine MSCs were (2 106/ml) mixed to both bioinks to have an overall seeding density of 500 105 porcine MSCs/construct before being cross-linked with 60 mM CaSO4. Both bioinks were printed within the PCL framework to generate two experimental groups: (i) Fast release, fast release bioink loaded with BMP-2 (2 g/ml; 0.5 g per construct) deposited only in the periphery with the fast release bioink not loaded with BMP-2 in the center; and (ii) Slow release, slow release bioink loaded with BMP-2 (2 g/ml; 0.5 g per construct) deposited only in the periphery with the fast release bioink not loaded with BMP-2 in the center (see Fig. 2A). Postprinting constructs were cross-linked again in a bath of 100 mM CaCl2 for 1 min.

For the rat femoral defect, the vascular bioink, the osteoinductive bioink, and a base bioink (3.5% RGD -irradiated alginate and 1.75% methylcellulose) were prepared, cross-linked with 60 mM CaSO4, and printed within the PCL framework to generate three experimental groups: (i) VEGF Gradient, the vascular bioink loaded with VEGF (500 ng/ml) in the center of the implant and base bioink in the periphery; (ii) BMP-2 gradient, the osteoinductive bioink loaded with BMP-2 (10 g/ml) in the implant periphery (2 g per construct), with the base bioink in the center; and (iii) Composite (VEGF+BMP-2), the osteoinductive bioink in the periphery with the vascular bioink in the center (see Fig. 3A). Postprinting constructs were cross-linked again in a bath of 100 mM CaCl2 for 1 min.

Subcutaneous surgeries were performed on 20 8-week-old female BALB/c OlaHsd-Foxn 1nu nude mice (12 mice for the VEGF gradient study and 8 for the BMP-2 gradient study) (Envigo, Oxon, UK) as previously described (47). Scaffolds were 3D printed the morning of surgeries and implanted that day. Constructs were implanted in a balanced manner, such that each group contained an implant placed at each of the two subcutaneous locations and samples were randomly distributed across the operated animals.

For the rat segmental surgery, 72 12-week-old F344 Fischer male rats (Envigo, Oxon, UK) were anesthetized in an induction box using a mix of isoflurane and oxygen, initially at a flow rate of isoflurane of 5 liters/min to induce, followed by ~3 liters/min to maintain anesthesia. Once anesthetized, the animal was transferred to a heating plate that was preheated to 37C and preoperative analgesia was provided by buprenorphine (0.03 mg/ml). Surgical access to the femur was achieved via an anterolateral longitudinal skin incision and separation of the hindlimb muscles, the vastus lateralis, and biceps femoris. The femoral diaphysis was exposed by circumferential elevation of attached muscles, and the periosteum was removed. Before the creation of the defect, a PEEK plate was fixed to the anterolateral femur and was held in position using a clamp. Holes were created in the femur with a surgical drill using the plate as a template. Screws were then inserted into the drill holes in the femur to maintain the fixation plate in position. A 5-mm segmental defect was created using an oscillating surgical saw under constant irrigation with sterile saline solution. In the test groups, a scaffold was placed in the defect after a thorough washout of the surgical site. In the case of the empty defect group, the gap between bone ends was left empty. Soft tissue was accurately readapted with absorbable suture material. Closure of the skin wound was achieved using suture material and tissue glue.

Eight weeks after surgery, the BMP-2 gradient scaffolds were extracted and incubated in paraformaldehyde for 24 hours before being imaged via CT scans on a MicroCT42 (Scanco Medical, Brttisellen, Switzerland) as previously described (47).

Two weeks after surgery, 24 rats underwent a vascular perfusion protocol developed by Daly et al. (28). Briefly, the rat was sacrificed using CO2 asphyxiation, and the thoracic cavity was opened to insert a 20-gauge needle through the left ventricle of the heart. The inferior cava was cut and solutions of heparin (25 U/ml), and then, phosphate-buffered saline (PBS) was perfused through the vasculature using a peristaltic pump (Masterflex, Cole-Parmer, Vernon Hills, IL, USA) until the vasculature system was completely flushed clear. A solution of 10% formalin was then perfused for 5 min. Animals received a final perfusion of 20- to 25-ml radiopaque contrast agent MICROFIL (Flow Tech, Carver, MA, USA) and were left at 4C overnight. Explants were extracted and incubated in PBS for 24 hours before being imaged via CT scans on a MicroCT42 (Scanco Medical, Brttisellen, Switzerland) at 70 kVp, 113 A, and a 10-m voxel size. The volume of interest (VOI) was determined by positioning a 5-mm circle around the cross section of the femur with an overall length of 6.26 mm. MICROFIL has the same threshold as bone mineral, and therefore, to segment perfused vasculature from mineralized tissue within each construct, two scans were analyzed: calcified construct versus decalcified construct. The calcified constructs were scanned and postprocessed using a threshold value that accurately depicted both the mineral content and the vessel volume by visual inspection of the 2D grayscale tomograms (Scanco Medical MicroCT42). Noise was removed using a low-pass Gaussian filter (sigma = 1.2, support = 2), and a global threshold of 210 was applied. Next, samples were decalcified in EDTA (15 weight %, pH 7.4) for 2 weeks with the decalcification solution replaced daily (decalcified constructs). After 2 weeks, these decalcified constructs were scanned using the same settings and postprocessed at the same threshold as the calcified constructs to determine mineral content. Mineralized tissue content was determined by subtracting the bone volume of the decalcified scans from the calcified scans. Next, the decalcified scans were postprocessed at a threshold of 99 that accurately depicted just the vessel volume upon visual inspection of the 2D grayscale tomograms.

CT scans were performed on the rats using a Scanco Medical vivaCT 80 system (Scanco Medical, Bassersdorf, Switzerland). Rats (n = 9) were scanned at 4, 8, 10, and 12 weeks after surgery to assess defect bridging and bone formation within the defect. First, anesthesia was induced in an induction box using a mix of isoflurane and oxygen, initially at a flow rate of isoflurane of 5 liters/min to induce, followed by ~3 liters/min to maintain anesthesia. Next, the rats were placed inside the vivaCT scanner, and anesthesia was maintained by isoflurane-oxygen throughout the scan. Next, a radiographic scan of the whole animal was used to isolate the rat femur. The animals femur was aligned parallel to the scanning field of view to simplify the bone volume assessments. Scans were performed using a voltage of 70 kVp and a current of 113 A. A Gaussian filter (sigma = 0.8, support = 1) was used to suppress noise, and a global threshold of 210 was applied. A voxel resolution of 35 m was used throughout. 3D evaluation was carried out on the segmented images to determine bone volume and density and to reconstruct a 3D image. Bone volume and bone density in the defects were quantified by measuring the total quantity of mineral in the central 130 slices of the defect. To differentiate regional differences in bone formation, three VOIs were created. Concentric 2 mm, 4 mm, and 10 mm were aligned with the defect and used to encompass bone formation. The VOIs were aligned using untreated native bone along the femur. The core bone volume was quantified from the inner 2-mm VOI. The annular bone volume was quantified by subtracting the 2-mm VOI from the 4-mm VOI. Ectopic bone volume was quantified by subtracting the 4-mm VOI from the 10-mm VOI. The bone volume percentages for each region were then calculated by dividing the corresponding bone volume (i.e., bone volume in the annulus) by the total bone volume in the defect. The bone volume and densities were then quantified using scripts provided by Scanco.

For segmental defect samples, all constructs that were not being processed for vascular-CT imaging, were decalcified in Decalcifying Solution-Lite (Sigma-Aldrich) for 1 week before tissue processing. Once decalcified, all samples were dehydrated and embedded in paraffin using an automatic tissue processor (Leica ASP300, Leica). All samples were sectioned with a thickness of 8 m using a rotary microtome (Leica Microtome RM2235, Leica). Sections were stained with H&E for vessel infiltration, Safranin O to assess sulphated glycosaminoglycans (sGAG) content, and Goldners trichrome for bone formation. Quantitative analysis was performed on multiple H&E-stained slices, whereby vessels (positive staining for endothelium and erythrocytes present within the lumen), were counted on separate sections taken throughout each construct and averaged for each construct. Safranin O sections were evaluated for new developing bone (positive sGAG content). Massons trichromestained sections were evaluated for new bone formation. The percentage of developing bone, new bone, and marrow per total area of construct was measured in separate sections with the Deconvolution ImageJ plugin.

Immunofluorescence analysis was used to detect -SMA and vWF as previously described (47). Briefly, following blocking step, sections were then incubated overnight at +4C with goat polyclonal -SMA (1:250; ab21027, Abcam) in PBS with 3% of donkey serum (w/v) and 1% bovine serum albumin (BSA). After three washing steps with PBS containing 1% w/v BSA, the sections were incubated with Alexa Fluor 488 donkey anti-goat secondary antibody (1:200; ab150129, Abcam) for 1 hour at room temperature in the dark. The samples were washed three times in PBS with 1% w/v BSA, and the slides were then incubated overnight at +4C with rabbit polyclonal vWF antibody (1:200; ab6994, Abcam) in PBS with 3% of donkey serum (w/v) and 1% BSA (all from Sigma-Aldrich). After three washing steps with PBS and 1% w/v BSA, the sections were incubated with Alexa Fluor 647 donkey anti-rabbit secondary antibody (1:200; ab150075, Abcam) for 1 hour at room temperature in the dark. Last, samples were washed three times with PBS and 1% w/v BSA, and the sections were mounted using 4,6-diamidino-2-phenylindole mounting media (Sigma-Aldrich). Fluorescence emission was detected using a confocal laser scanning microscopy (Olympus FluoView 1000).

Results were expressed as means SD. Statistics was performed using the following variables: (i) When there were two groups and one time point, a standard two-tailed t test was performed. (ii) When there were more than two groups and one time point, a one-way analysis of variance (ANOVA) was performed. (iii) When there were more than two groups and multiple time points, a two-way ANOVA was performed. All analyses were performed using GraphPad (GraphPad Software, La Jolla, CA, USA; http://www.graphpad.com). For all comparisons, the level of significance was P 0.05.

Acknowledgments: We thank the staff at the Bioresources Unit in Trinity College Dublin for veterinary assistance and technical support. Funding: This publication has emanated from research supported by a research grant from the European Research Council (ERC) under grant no. 647004, the Irish Research Council (GOIPD/2016/324), and NIHs NIAMS grant R01AR063194. Author contributions: F.E.F. was responsible for technical design, development of bioinks, performing all animal surgeries, performing vessel perfusion, all CT scans, data interpretation, histological analysis, and drafting the paper. P.P. assisted with the rat surgeries and assisted with the vessel perfusions. L.H.A.v.D. assisted with CT analyses and CT scans. J.N. and D.C.B. assisted with all animal surgeries. J.-Y.S. and E.A. developed the RGD -irradiated alginate. D.J.K. conceived and helped design the experiments, oversaw the collection of results and data interpretation, and finalized the paper. Competing interests: Research undertaken in the laboratory of D.J.K. at Trinity College Dublin is part-funded by Johnson & Johnson. The authors declare no other competing interests. Data and materials availability: All data needed to evaluate the conclusions in the paper are present in the paper and/or the Supplementary Materials. Additional data related to this paper may be requested from the authors.

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3D bioprinting spatiotemporally defined patterns of growth factors to tightly control tissue regeneration - Science Advances

Recommendation and review posted by Bethany Smith

Persistence Market Research recently published a market study that sheds light on the growth prospects of the global Predictive Genetic Testing market during the forecast period (20XX-20XX). In addition, the report also includes a detailed analysis of the impact of the novel COVID-19 pandemic on the future prospects of the Predictive Genetic Testing market. The report provides a thorough evaluation of the latest trends, market drivers, opportunities, and challenges within the global Predictive Genetic Testing market to assist our clients arrive at beneficial business decisions.

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Predictive Genetic Testing Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 2029 - The Daily Chronicle

Recommendation and review posted by Bethany Smith

HOUSTON, Aug. 13, 2020 /PRNewswire/ --Baylor Genetics, a clinical diagnostics laboratory known for genetic testing and precision medicine, and Rice University, a private, comprehensive research university located in Houston, Texas, have partnered together to create a first-of-its-kind, total turnkey solution for the university to resume in-person classes for the fall semester despite the COVID-19 pandemic.

"For Baylor Genetics and Rice University, this partnership represents a moon-shot opportunity to benefit students, faculty, and staff," stated Kengo Takishima, President and Chief Executive Officer at Baylor Genetics. "It is imperative families have peace of mind as they send their children to college and we've set an aggressive goal of serving as a blueprint for other academic institutionsand, more broadly, society."

Many universities nationwide have been strongly impacted by the pandemic and have announced changes to the fall semester. One of the major changes is universities going fully online for the semester. Fortunately, Rice has been able to overcome many challenges brought on by COVID-19 thanks to its partnership with Baylor Genetics.

"In terms of learning online, I found that it wasn't that intuitive and effective for my own learning style. In addition to that, it is my senior year and I wanted to get one last taste of the community that I have come to grow and love here," said Victor Nguyen, a senior at Rice University, in an interviewreleased by the university. "Being on campus again feels a little bit more of what we are used to, even though we live in a new reality. It's closer to normal so it's exactly what we were hoping for."

This partnership entails Baylor Genetics providing support for temperature checks, on-campus sample collection and transport logistics, processing of samples, and customized results reporting for individuals via email. Nearly 60,000 screening tests will be performed by Baylor Genetics with a turnaround time of 48 hours or less.

In addition to large-scale surveillance testing, the partnership includes population management reporting. This custom reporting system delivers population data to assist policymakers at Rice with managing the campus community and by aiding in intelligent decision making.

"Testing by itself is not enough," said Kevin Kirby, Rice University's Vice President for Administration."What matters is how we use that information to act quickly to isolate, treat, contact trace, and quarantine those affected. A systematic approach is the best practice for creating an environment that will mitigate the spread of COVID-19."

In addition, data tracking will provide the university with specific trends and infection rates on buildings, facilities, and housing throughout the campus. This innovative approach is part of Rice's strategy to prevent cross-contamination and ensure the safety of its faculty, students, and staff. There are plans to extend the partnership with symptomatic testing in the near future.

"This opportunity is a chance to demonstrate that we can operate safely in such a difficult time," said Chad Shaw, Ph.D., Sr. Director of the Baylor Genetics Innovation Lab, Adjunct Professor of Statistics at Rice University, and Professor in the Department of Molecular and Human Genetics at Baylor College of Medicine, "As a Houstonian and a member of both the Baylor and Rice faculty, I am excited by the opportunity to serve my community to find a thoughtful and creative way to overcome the COVID challenge. It takes commitment, grit, and a team effort."

The program began the week of Aug. 3 with college staff, graduate students, and orientation coordinators. For students, testing is broken down into three phases and will begin Aug. 15. There will be no charge to faculty, studentsor staff for the on-campus testing.

For members of the Rice community that are confirmed positive for the coronavirus (SARS-CoV-2), Rice will follow the Centers for Disease Control and Prevention contact-tracing protocols to identify others who have had significant contact with those tested positive.

Baylor Genetics' test for COVID-19 has one of the highest sensitivity (true positive rate) and specificity (true negative rate) rates for identifying active coronavirus infection. All precautions, policies, and guidelines have been put in place with one goal in mind continue education in the safest, most effective way possible.

Media Contact:Jamie LimEmail: [emailprotected]

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Baylor Genetics and Rice University Form COVID-19 Screening Partnership for the Fall Semester; Partnership Aims for 'Moon-Shot' 48-Hours-or-Less...

Recommendation and review posted by Bethany Smith

New Jersey, United States,- This detailed market research covers the growth potential of the Direct-To-Consumer (DTC) Genetic Testing Market, which can help stakeholders understand the key trends and prospects of the Direct-To-Consumer (DTC) Genetic Testing market and identify growth opportunities and competitive scenarios. The report also focuses on data from other primary and secondary sources and is analyzed using a variety of tools. This will help investors better understand the growth potential of the market and help investors identify scope and opportunities. This analysis also provides details for each segment of the global Direct-To-Consumer (DTC) Genetic Testing market.

The report was touted as the most recent event hitting the market due to the COVID-19 outbreak. This outbreak brought about a dynamic change in the industry and the overall economic scenario. This report covers the analysis of the impact of the COVID-19 pandemic on market growth and revenue. The report also provides an in-depth analysis of the current and future impacts of the pandemic and post-COVID-19 scenario analysis.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

The market is further segmented on the basis of types and end-user applications. The report also provides an estimation of the segment expected to lead the market in the forecast years. Detailed segmentation of the market based on types and applications along with historical data and forecast estimation is offered in the report.

Furthermore, the report provides an extensive analysis of the regional segmentation of the market. The regional analysis covers product development, sales, consumption trends, regional market share, and size in each region. The market analysis segment covers forecast estimation of the market share and size in the key geographical regions.

The report further studies the segmentation of the market based on product types offered in the market and their end-use/applications.

Global Direct-to-Consumer (DTC) Genetic Testing Market, By Test Type

Predictive Testing Carrier Testing Nutrigenomics Testing Others

Global Direct-to-Consumer (DTC) Genetic Testing Market, By Technology

Single Nucleotide Polymorphism Chips Whole Genome Sequencing Targeted Analysis

On the basis of regional segmentation, the market is bifurcated into major regions ofNorth America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.The regional analysis further covers country-wise bifurcation of the market and key players.

The research report offered by Verified Market Research provides an updated insight into the global Direct-To-Consumer (DTC) Genetic Testing market. The report covers an in-depth analysis of the key trends and emerging drivers of the market likely to influence industry growth. Additionally, the report covers market characteristics, competitive landscape, market size and growth, regional breakdown, and strategies for this market.

Highlights of the TOC of the Direct-To-Consumer (DTC) Genetic Testing Report:

Overview of the Global Direct-To-Consumer (DTC) Genetic Testing Market

Market competition by Players and Manufacturers

Competitive landscape

Production, revenue estimation by types and applications

Regional analysis

Industry chain analysis

Global Direct-To-Consumer (DTC) Genetic Testing market forecast estimation

This Direct-To-Consumer (DTC) Genetic Testing report umbrellas vital elements such as market trends, share, size, and aspects that facilitate the growth of the companies operating in the market to help readers implement profitable strategies to boost the growth of their business. This report also analyses the expansion, market size, key segments, market share, application, key drivers, and restraints.

Key Questions Addressed in the Report:

What are the key driving and restraining factors of the global Direct-To-Consumer (DTC) Genetic Testing market?

What is the concentration of the market, and is it fragmented or highly concentrated?

What are the major challenges and risks the companies will have to face in the market?

Which segment and region are expected to dominate the market in the forecast period?

What are the latest and emerging trends of the Direct-To-Consumer (DTC) Genetic Testing market?

What is the expected growth rate of the Direct-To-Consumer (DTC) Genetic Testing market in the forecast period?

What are the strategic business plans and steps were taken by key competitors?

Which product type or application segment is expected to grow at a significant rate during the forecast period?

What are the factors restraining the growth of the Direct-To-Consumer (DTC) Genetic Testing market?

Thank you for reading our report. The report is available for customization based on chapters or regions. Please get in touch with us to know more about customization options, and our team will ensure you get the report tailored according to your requirements.

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Direct-To-Consumer (DTC) Genetic Testing Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 -...

Recommendation and review posted by Bethany Smith

Dublin, Aug. 14, 2020 (GLOBE NEWSWIRE) -- The "DTC (Direct to Consumer) DNA Test Kits Market - Growth, Trends, and Forecasts (2020-2025)" report has been added to ResearchAndMarkets.com's offering.

The Global DTC DNA Test Kits Market is anticipated to grow with a CAGR of nearly 24% during the forecast period.

The major factors attributing to the growth of this market are increasing demand for paternity testing, rising prevalence of hereditary diseases, and rise in interest of consumers & physicians in DTC kits & consequent rise in sales of DNA test kits.

Furthermore, the growing number of laboratories researching the DNA kits for gynecological purposes is also a major factor that drives the market growth. For instance, the National Congenital Anomaly and Rare Disease Registration Service has stated that around 3 to 6% of babies worldwide are born with a congenital anomaly every year, this increases the need for the prenatal testing for anomalies. The difficulty in understanding the results of the kits and very less information about the companies selling the kits are restraining the growth of the market.

Furthermore the market is largely penetrating towards new research fields of medicine and healthcare as such the innovation of probes for preimplantation, prenatal, and postnatal genetic testing research drives the overall market growth.

Key Market Trends

Demand for Ancestry Testing is Expected to Increase During the Forecast Period

An ancestry test is a DTC DNA-based test that reads specific locations of a subject's genome, to find or validate ancestral hereditary relationships or to evaluate the ethnic combination of an individual. The increasing number of people who are interested in knowing their ancestors and family tree increases the demand for DTC DNA test kits, especially in developing countries.

The increasing number of companies such as 23andMe are found to offer various DNA kits that are helpful in ancestry testing. Developed countries are also witnessing the high demand for such products as awareness about such technologies is higher.

North America Dominates the Market and Expected to do Same in the Forecast Period

North America is expected to dominate the overall DTC DNA test kits market, throughout the forecast period. The growth is due to factors such as the growing prevalence of congenital anomalies and increasing government initiatives for genetic diagnosis. In the North America region, the United States holds the largest market share due to factors such as high disposable income, and easy acceptance of such kits in the country is expected to increase the demand in this region.

However, Asia Pacific is anticipated to be the fastest-growing market due to the increasing awareness programs and developments undertaken by government bodies to accelerate genetic research in Asian countries. The Asia Pacific will proliferate at a speedy rate due to rapid technological updation in the healthcare sector.

Competitive Landscape

The market studied is moderately competitive and consists of few major players. Growing biotech industry is augmenting the rise in new entrants in this market. It is belived that there will be penetration of the few small to mid sized compaies in this market.

Key Topics Covered

1 INTRODUCTION1.1 Study Deliverables1.2 Study Assumptions1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS4.1 Market Overview4.2 Market Drivers4.2.1 Increasing Demand for Paternity Testing4.2.2 Increasing Number of Hereditary Diseases4.2.3 Rise in Interest of Consumers & Physicians in DTC Kits & Consequent Rise in Sales of DNA Test Kits4.3 Market Restraints4.3.1 Lack of Awareness and Proper Genetic Counselling4.3.2 Regulatory Challenges Pertaining to the Use of DTC Genetic Tests4.4 Porter's Five Force Analysis

5 MARKET SEGMENTATION5.1 By Sample Type5.1.1 Saliva5.1.2 Cheek Swab5.2 By Application5.2.1 Genetic Relatedness5.2.2 Health & Fitness5.2.3 Ancestry Testing5.2.4 Other Applications5.3 Geography5.3.1 North America5.3.2 Europe5.3.3 Asia-Pacific5.3.4 Middle-East & Africa5.3.5 South America

6 COMPETITIVE LANDSCAPE6.1 Company Profiles6.1.1 Ancestry.com LLC6.1.2 23andMe6.1.3 MyHeritage Ltd.6.1.4 Gene by Gene6.1.5 Living DNA Ltd.6.1.6 National Geographic Partners, LLC6.1.7 Helix OpCo, LLC6.1.8 Veritas6.1.9 Futura Genetics6.1.10 Illumina, Inc.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

For more information about this report visit https://www.researchandmarkets.com/r/mvzrhk

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Read more from the original source:
Global DTC DNA Test Kits Industry Outlook, 2025 - Demand for Ancestry Testing Expected to Increase - GlobeNewswire

Recommendation and review posted by Bethany Smith

What to Know About Your Ovarian Cancer Genes

Most of the time, ovarian cancer happens randomly. Genetic changes occur spontaneously within cells that make them turn cancerous. But a smaller percentage of women with ovarian cancer have inherited a genetic predisposition that make them more likely to develop this cancer. Testing for these inherited gene changes can help better target the treatment women receive, and inform the health decisions their family members make.

The most important thing for a woman whos been newly diagnosed with ovarian cancer or tubal cancer to know is that its very important to get genetic testing, because almost 25% of women who have a new diagnosis of ovarian cancer will be found to have a genetic mutation, explains Dr. Karen Zempolich, gynecologic oncologist at St. Marks Hospital in Salt Lake City.

Many women have heard of BRCA mutations, Dr. Zempolich says. Normally, the BRCA1 and BRCA2 genes protect you against cancer by helping your cells repair broken DNA that can turn the cells cancerous. But when these genes are changed, or mutated, cells can no longer fix themselves.

People who inherit the BRCA gene mutations are more likely to get not only ovarian cancer, but also breast cancer. There are also many other genes that contribute to ovarian cancer, which genetic testing can reveal. Getting tested can also help your doctor make more informed decisions about your treatment.

Learning that you have a genetic mutation is not only important for determining your risk of ovarian and breast cancers, but it also gives your doctor the chance to use a whole new set of medicines against ovarian cancer that could improve your survival, Dr. Zempolich says.

Normally when a strand of DNA is damaged, enzymes called PARPs rush in to fix the damage. New medicines called PARP inhibitors help counteract that protective mechanism, she says. Cancer cells cant finish the repair process, so they stop growing and spreading.

PARP inhibitor drugs work best in women who have BRCA1 and BRCA2 mutations, because the cancer cells are already at a loss to repair themselves. Taking PARP inhibitors can extend the time before a womans cancer comes back, and possibly prolong her survival.

If a woman has a BRCA or other gene mutation, there may be a good chance that her family members carry it too, since these mutations are inherited. Families with BRCA mutations and multiple cases of ovarian and/or breast cancers are said to have a cancer predisposition syndrome called Hereditary Breast and Ovarian Cancer Syndrome (HBOC).

Knowing their genetic status can inform important health decisions for everyone in the family. Women who test positive for genes linked to ovarian cancer may want to consider having prophylactic surgery, removing their ovaries and fallopian tubes to prevent cancer from developing in the future.

Its important for men to also consider their genetic risks. The gene mutations that are linked to ovarian cancer also increase the risk for breast cancer (which men can get too), as well as for colon cancer, melanoma, and upper GI tract cancers, Dr. Zempolich says.

Once youve been diagnosed with ovarian cancer, your doctor will likely send you for genetic testing. Most insurance companies should cover the cost, Dr. Zempolich says.

If your doctor isnt sure whether you have a familial ovarian cancer syndrome, you can meet with a genetic counselor to determine what, if any, testing you need. The counselor can help you decide whether or not thats an important part of your journey with this cancer, she adds.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Karen Zempolich is a gynecologic oncologist at St. Mark's Hospital in Salt Lake City, Utah. She specializesin complex pelvic and oncologic surgery, laparoscopic surgery, and fertility-sparing treatment of early gynecologic cancers. Read More

The most important thing for a woman whos been newly diagnosed with ovarian cancer or tubal cancer to know is that its very important to get genetic testing, because almost 25% of women who have a new diagnosis of ovarian cancer will be found to have a genetic mutation, explains Dr. Karen Zempolich, gynecologic oncologist at St. Marks Hospital in Salt Lake City.

People who inherit the BRCA gene mutations are more likely to get not only ovarian cancer, but also breast cancer. There are also many other genes that contribute to ovarian cancer, which genetic testing can reveal. Getting tested can also help your doctor make more informed decisions about your treatment.

Learning that you have a genetic mutation is not only important for determining your risk of ovarian and breast cancers, but it also gives your doctor the chance to use a whole new set of medicines against ovarian cancer that could improve your survival, Dr. Zempolich says.

Normally when a strand of DNA is damaged, enzymes called PARPs rush in to fix the damage. New medicines called PARP inhibitors help counteract that protective mechanism, she says. Cancer cells cant finish the repair process, so they stop growing and spreading.

PARP inhibitor drugs work best in women who have BRCA1 and BRCA2 mutations, because the cancer cells are already at a loss to repair themselves. Taking PARP inhibitors can extend the time before a womans cancer comes back, and possibly prolong her survival.

If a woman has a BRCA or other gene mutation, there may be a good chance that her family members carry it too, since these mutations are inherited. Families with BRCA mutations and multiple cases of ovarian and/or breast cancers are said to have a cancer predisposition syndrome called Hereditary Breast and Ovarian Cancer Syndrome (HBOC).

Knowing their genetic status can inform important health decisions for everyone in the family. Women who test positive for genes linked to ovarian cancer may want to consider having prophylactic surgery, removing their ovaries and fallopian tubes to prevent cancer from developing in the future.

Its important for men to also consider their genetic risks. The gene mutations that are linked to ovarian cancer also increase the risk for breast cancer (which men can get too), as well as for colon cancer, melanoma, and upper GI tract cancers, Dr. Zempolich says.

Once youve been diagnosed with ovarian cancer, your doctor will likely send you for genetic testing. Most insurance companies should cover the cost, Dr. Zempolich says.

If your doctor isnt sure whether you have a familial ovarian cancer syndrome, you can meet with a genetic counselor to determine what, if any, testing you need. The counselor can help you decide whether or not thats an important part of your journey with this cancer, she adds.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Karen Zempolich is a gynecologic oncologist at St. Mark's Hospital in Salt Lake City, Utah. She specializesin complex pelvic and oncologic surgery, laparoscopic surgery, and fertility-sparing treatment of early gynecologic cancers. Read More

Here is the original post:
How Genes Can Shape A Womans Ovarian Cancer Care, And Her Familys Medical Decisions - SurvivorNet

Recommendation and review posted by Bethany Smith

New Jersey, United States,- Verified Market Researchhas recently published an extensive report on the Direct-To-Consumer (DTC) Genetic Testing Market to its ever-expanding research database. The report provides an in-depth analysis of the market size, growth, and share of the Direct-To-Consumer (DTC) Genetic Testing Market and the leading companies associated with it. The report also discusses technologies, product developments, key trends, market drivers and restraints, challenges, and opportunities. It provides an accurate forecast until 2027. The research report is examined and validated by industry professionals and experts.

The report also explores the impact of the COVID-19 pandemic on the segments of the Direct-To-Consumer (DTC) Genetic Testing market and its global scenario. The report analyzes the changing dynamics of the market owing to the pandemic and subsequent regulatory policies and social restrictions. The report also analyses the present and future impact of the pandemic and provides an insight into the post-COVID-19 scenario of the market.

Global Direct-to-Consumer (DTC) Genetic Testing Market was valued at USD 789.92 Million in 2018 and is projected to reach USD 2,361.12 Billion by 2026, growing at a CAGR of 14.59% from 2019 to 2026.

The report further studies potential alliances such as mergers, acquisitions, joint ventures, product launches, collaborations, and partnerships of the key players and new entrants. The report also studies any development in products, R&D advancements, manufacturing updates, and product research undertaken by the companies.

Leading Key players of Direct-To-Consumer (DTC) Genetic Testing Market are:

Competitive Landscape of the Direct-To-Consumer (DTC) Genetic Testing Market:

The market for the Direct-To-Consumer (DTC) Genetic Testing industry is extremely competitive, with several major players and small scale industries. Adoption of advanced technology and development in production are expected to play a vital role in the growth of the industry. The report also covers their mergers and acquisitions, collaborations, joint ventures, partnerships, product launches, and agreements undertaken in order to gain a substantial market size and a global position.

Global Direct-to-Consumer (DTC) Genetic Testing Market, By Test Type

Predictive Testing Carrier Testing Nutrigenomics Testing Others

Global Direct-to-Consumer (DTC) Genetic Testing Market, By Technology

Single Nucleotide Polymorphism Chips Whole Genome Sequencing Targeted Analysis

Regional Analysis of Direct-To-Consumer (DTC) Genetic Testing Market:

A brief overview of the regional landscape:

From a geographical perspective, the Direct-To-Consumer (DTC) Genetic Testing Market is partitioned into

North Americao U.S.o Canadao MexicoEuropeo Germanyo UKo Franceo Rest of EuropeAsia Pacifico Chinao Japano Indiao Rest of Asia PacificRest of the World

Key coverage of the report:

Other important inclusions in Direct-To-Consumer (DTC) Genetic Testing Market:

About us:

Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

Contact us:

Mr. Edwyne Fernandes

US: +1 (650)-781-4080UK: +44 (203)-411-9686APAC: +91 (902)-863-5784US Toll-Free: +1 (800)-7821768

Email: [emailprotected]

View original post here:
Direct-To-Consumer (DTC) Genetic Testing Market Size by Top Companies, Regions, Types and Application, End Users and Forecast to 2027 - Bulletin Line

Recommendation and review posted by Bethany Smith

The research report on the Direct-to-consumer Genetic Testing market leverages iterative and comprehensive research methodology to deliver insights regarding the current market scenario over the study timeframe. The report dives deep into the development trends that will influence the behavior of the Direct-to-consumer Genetic Testing + market in the forthcoming years. Moreover, other key pointers such as the regional characteristics and policies governing the industry are highlighted in the research. Apart from this, the study incorporates the impact of the COVID-19 pandemic on the revenue share and annual growth rate of the industry.

A new report on Direct-to-consumer Genetic Testing market that provides a comprehensive review of this industry with respect to the driving forces influencing the market size. Comprising the current and future trends defining the dynamics of this industry vertical, this report also incorporates the regional landscape of Direct-to-consumer Genetic Testing market in tandem with its competitive terrain.

The market analysis showcases the vast research on the product terrain which is inclusive of the advantages and disadvantages of the products developed by the various manufacturers. Besides this, an investigation of the evolution of the competitive dynamics along with details pertaining to raw material supply chain and downstream buyers are presented in the report.

Request Sample Copy of this Report @ https://www.express-journal.com/request-sample/169156

A gist of the competitive landscape of the Direct-to-consumer Genetic Testing market:

An outline of the regional scope of the Direct-to-consumer Genetic Testing market:

Global Direct-to-consumer Genetic Testing Market Segmentation:This market has been divided into Types, Applications, and Regions. The growth of each segment provides an accurate calculation and forecast of sales by Types and Applications, in terms of volume and value for the period between 2020 and 2026. This analysis can help you expand your business by targeting qualified niche markets. Market share data is available on the global and regional level.

Additional takeaways from the Direct-to-consumer Genetic Testing market report:

Highlights points of Direct-to-consumer Genetic Testing Industry:

Key questions answered in the report:

Request Customization on This Report @ https://www.express-journal.com/request-for-customization/169156

More here:
Direct-to-consumer Genetic Testing Market Research Growth by Manufacturers, Regions, Type and Application, Forecast Analysis to 2025 - Express Journal

Recommendation and review posted by Bethany Smith

Many countries have never experienced a major oil spill. The critical steps taken in the early days ... [+] can make all the difference to the cleanup that may be needed for decades to come.

Major oil spills, like what happened on the Indian Ocean Island of Mauritius last Thursday, are unfortunately more common than they should be.

Years of forcing the global shipping industry to increase sustainability and safety standards have not yielded sufficient results, as international shipping continues to lag behind on climate change commitments.

This has placed many smaller nations, without the resources to handle a major oil incident, woefully unprepared to deal with the complexity and magnitude of how to handle major industrial oil spill, as Mauritius found to its cost last week. As an aging and abandoned large crude oil tanker off the coast of Yemen is also at risk of spilling across the entire Red Sea, causing the US Secretary of State to issue an alert, what steps do countries have to take if a major oil spill hits their shores for the first time?

What happens when there is an oil spill and what steps should a country take, particularly if theyve never experienced such an event.

It all eventually boils down to two questions.

A bi-partisan US Congress hosts a hearing in 2007 on the Cosco Busan Heavy Fuel Oil spill in San ... [+] Francisco Bay during the Independent Accident Investigation as well as Natural Resources Damage Assessment - key tools to conducting any meaningful inquiry.

After all is said and done, oil cleanup operations come down to two questions: who pays, and how much do they pay. Some key early decisions could mean an order of magnitude (ten times) difference in any payout. This is critical to know.

All major shipping companies pay into catastrophic risk insurance. Ultimately, any funds for restoration of habitats will come from this pooled risk insurance that has pockets of billions of dollars. As a comparison, compensation for the Deepwater Horizon oil spill in 2010, which had a robust scientific assessment behind it, was $20 billion, for Exxon Valdez oil spill in 1989 it was $5 billion (over $10.5 billion in todays prices). If bilateral settlement terms for what is a reasonable cost of cleanup cannot be reached, this will often go to arbitration. This is a well understood process.

At such arbitration, the quality of the data collected in the early days of the incident will make all the difference in the decision of the magnitude of payout made.

Here are the five critical steps that any country experiencing an oil spill must take in the immediate days following a crisis.

Salvage teams work on containment of oil as well as ensuring the stability of the vessel during the ... [+] initial Containment phase.

There are two aspects to this: containing the oil spill itself, and salvaging the vessel. This often entails two different sets of experts for each challenge.

A key group of international technical experts in suggesting effective spill response techniques to a maritime incident is ITOPF. They are usually activated by a vessels owner and insurer. They may organize a spill response team, such as Oil Spill Response Limited, which are the largest international industry-funded cooperative that exists to respond to oil spills wherever in the world they may occur, by providing preparedness, response and intervention services. They are wholly owned by most of the environmentally responsible oil and gas companies, who employ 275 people across 12 locations around the world. They also respond to spills for non-members, subject to a set of pre-set fees.

They are the teams who advise and lead on the initial operational details of containing the oil spill, including at distances far from the actual accident site itself.

In cases where vessels have been structurally impacted, the experts are typically the large, global, salvage companies who are appointed by the ships owners and insurers.

Proper scientific protocols must be followed to ensure any evidence collected can be admitted into ... [+] the investigation, for example using gloves, and correctly documenting and storing samples following an approved chain of custody.

Whilst in many countries there is often the initial shock, confusion and coordination challenges in the immediate aftermath of a spill, the samples collected in the immediate days following a spill (and continually in the following days and weeks), will be the biggest determination of any cleanup compensation payout.

No resource should be spared collecting these samples using the right scientific protocols that would be admissible in any arbitration. The pay off from extensive and well cataloged samples could mean the difference of a payout that is orders of magnitude (ten times) greater, and would justify any investment in the collection team and robust scientific protocols that could be admissible in any arbitration.

Once this window is missed, it may be too late to see the full extent of the damage caused, as lessons from the quality of sampling around the Cosco Busan show.

Biological samples (such as coral, fish, mangrove tissue) can reveal certain bio-markers of where the pollution may have traveled that is invisible to the naked eye or satellite evidence. To obtain these indicators, specimens need to be genetically tested using specialist genomic equipment that is widely available in the US and Europe.

SAR Satellite imagery reveals that the oil spill had drifted as far as Ile aux Cerfs by Tuesday ... [+] August 11 2020., 14 miles North of the crash site due to the heavy winds along the East Coast (this is a major kite surfing zone). This type of data may not be visible to the naked eye, but can help track the potential genetic marking impact of the spill.

Often such equipment is not present in the location of the spill and there is a several week delay for this to arrive (especially given Covid-19). However, this does not mean samples should not be collected daily from specific locations under specific protocols. These samples can be frozen and tested many weeks or months later when the right equipment arrives.

Incidentally, due to Mauritius strong response to Covid-19 (there are no local cases), many PCR kits are currently available which may end up being one of the most powerful tools in the oil spill response. That, combined with armies of specially trained volunteers from the tourism and fishing community who know the area, could give a strong advantage for a unified a national response.

The US Agency responsible for environmental impact assessments after a major oil spill, NOAA, offers ... [+] guidance to countries on how to best conduct such assessments, including the document templates to accurately log all specimens and samples that are collected.

What is most important for samples to be admitted in any arbitration settlement is the strict cataloging of the chain of custody and storage of the samples. The importance of this cannot be emphasized enough. Many cases have fallen apart when it was alleged that samples could have been tampered with.

Fortunately, Mauritius has a large and secure tuna industry and aquaculture facilities with refrigeration and security capacity that should address these concerns.

The documentation and protocols can be printed off from existing documentation, such as on Page 23 of NOAAs guide to Heavy Fuel Oil spills. Often a swift training is required for all collecting officers. Given the large local fishing and tourism sector around the crash location, Mauritius has the opportunity to secure and freeze a much more compelling set of baseline data than many other countries. Especially given how well studied and monitored the wildlife sanctuaries around the crash site were.

When major oil spill or mining accidents occur, there is often anger and confusion. Whilst there is ... [+] a process to determine what happened, a completely separate and de-politicized process should be run in parallel to get the world's best, independent scientific experts to conduct an extensive Natural Resource Damage Assessment. Image of protests at Brazilian Mining Giant, Vale, following a mining accident in 2019.

There is often a fog of war after a major oil spill, particularly where this happens in a country for the first time. It took two major oil spills (1969 Santa Barbara, California and 1989 Exxon Valdez) for the US to fully have its standard operating protocols and laws in place, so they could better handle the Cosco Busan in San Francisco Bay in 2007.

In most countries, there is often inter-departmental challenges. In the US, following major oil spills, the Port Authorities are often at odds with the Environmental Agencies (EPA and NOAA). However, in the most effective cases, they are put under the umbrella of the US Department of Justice to ensure a coordinated response with sufficient and fast-tracked funds, to ensure the best possible outcome for the citizens of the affected area.

Whilst there may initially be trade-offs between who pays for sample collections, scientific information, and other baseline impact studies, resourcing should be agreed in a unified way. In the United States, there are often well established established Accident Investigation Boards for major events that look into the forensics of the incidents and lessons learned. Such processes into the causes of what happened should be handled separately from preparing a strong and independent Natural Resource Damage Assessment case for compensation from any polluter.

Countries should engage their own, independent oil spill experts to assess the damage to the Natural ... [+] Resources. This team will be responsible for independently deciding sample location and overseeing the sample collection and storage process.

These should be separate from those provided by the polluting company, the insurer or any host nation associated with a polluter

This is critical. Given the magnitude in any payout, not all international experts are incentivized to offer objective advice. In many cases, it may be more prudent for the insurer to have a counter-narrative to diminish the potential impact (e.g., describing an environment that was already in decline, tourism was impacted by Covid-19 or that multiple factors were to blame, rather than what the insurer is responsible for).

Where a country has its own set of independent experts who have gone through major oil spills before, these countries are always more effectively prepared with a stronger, unified narrative. Given that settlements are often in the hundreds of millions of dollars and even billions of dollars, there are very high stakes here to have the right, independent experts on the side of the country and citizens who have been impacted.

A world class science team will ensure appropriate security and storage of all samples from as wide ... [+] a location as possible, to be admissible in any Natural Resources Damages Assessment

The centerpiece of any claim will come down to the credibility of the science presented. This will be determined by the quality of the samples and data collected (including how strictly scientific protocols were carried out and the extensiveness of the tests), as well as the quality of the experts engaged.

Often, a polluter or host nation would offer to pay for a scientific team. This could lead to sub-optimal outcomes for the host nation. Not all scientists are equal, and each may use different approaches to reduce their assessment of impact.

One example that has been seen in many places is for a scientist to cut fish into slices to visually look for the presence of oil as the main indicator. Whilst this makes for compelling media images, this does not give robust scientific information. When a fish takes in oil, it is akin to a human drinking alcohol. The liver de-toxifies (reduces the toxicity) of the alcohol. The only way to accurately assess the impact of an oil spill is through advanced genetic testing.

There is a specific gene that is sought for in genetic testing and that is the famous CYP1A gene (part of the family of CYP enzymes). This is a critical indicator in response to oil spills. This is a well known bio-marker that indicates the fish defense mechanisms have been activated against the pollution. If more of this enzyme is made, that may be an indicator that the fish trying to detoxify itself, as admissible evidence of stress due to the oil spill. This is the true measure to understand the impact of an oil spill (not visual inspection of a slice of fish), which reveals that oil spills are often the invisible killer to marine life. These bio-markers can easily be detected using PCR tests, that are commonly being used for Covid-19 testing.

The output from DNA results will look like a series of lines. Experts will know how to read these ... [+] and search for the CYP1A class of gene that indicates stress from oil pollution, and can be detected from PCR Kits.

Hence it is important that any country impacted agree swiftly on an international scientific team from an internationally respected university who can work with local scientists to jointly frame the right questions and focus immediately on collecting the right samples. With Exxon Valdez in Alaska, only a certain set of species population needed to be monitored. With more biodiverse areas, experts in animal diseases from corals, mangroves, birds, turtles, insects, dolphins, whales, crustaceans, plants, flowers and trees would need to be engaged to know which indicators to start searching for. Some of the worlds leading scientists who worked on behalf of the communities that secured the $20 billion settlement from BP from the Deepwater Horizon well blowout, are at Stanford Universitys Marine Hopkins Laboratory in California. They also happen to have some of the worlds deepest expertise in the Indian Ocean, covering coral reefs, fish and other rare marine life found only in the Indian Ocean.

If the funding party (the polluter or their sponsoring nation) does not agree to a highly credible, world class scientific team from a separate country, it is often prudent for the host Government to pay for this scientific expertise themselves and be reimbursed later during any settlement. These costs may be as high as $3 million initially for the full range of scientific logging, right equipment, and expertise that a world class scientific team can oversee and evaluate the samples being collected, working and training local scientists to build capacity long after the international scientists have left.

Bearing in mind that the Cosco Busans settlement was $44m for a spill that was in the heavily industrial San Francisco Bay three and a half times smaller than the Wakashio in Mauritius and significantly smaller than the risk from theSafer tanker off the coast of Yemen and the environmentally sensitive Red Sea with some of the last remaining Pristine Corals, the investment in the right internationally renown scientific team early on could immensely strengthen any case during arbitration.

Link:
The Critical First Five Steps Every Country Should Take When Responding To A Major Oil Spill - Forbes

Recommendation and review posted by Bethany Smith

LOS ANGELES, United States: QY Research has recently published a report, titled Global Breast Cancer Predictive Genetic Testing Market Size, Status and Forecast 2020-2026. The research report gives the potential headway openings that prevails in the global market. The report is amalgamated depending on research procured from primary and secondary information. The global Breast Cancer Predictive Genetic Testing market is relied upon to develop generously and succeed in volume and value during the predicted time period. Moreover, the report gives nitty gritty data on different manufacturers, region, and products which are important to totally understanding the market.

Key Companies/Manufacturers operating in the global Breast Cancer Predictive Genetic Testing market include: , Roche, Thermo Fisher Scientific, PerkinElmer, Quest Diagnostics, Myriad Genetics, Iverson Genetics, Cancer Genetics, OncoCyte Corporation, NeoGenomics, Invitae Breast Cancer Predictive Genetic Testing

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

https://www.qyresearch.com/sample-form/form/1967056/global-breast-cancer-predictive-genetic-testing-market

Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Breast Cancer Predictive Genetic Testing market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Global Breast Cancer Predictive Genetic Testing Market Segment By Type:

High Penetrant GenesIntermediate Penetrant GenesLow Penetrant Genes Breast Cancer Predictive Genetic Testing

Global Breast Cancer Predictive Genetic Testing Market Segment By Application:

HospitalsClinicsOther

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global Breast Cancer Predictive Genetic Testing market.

Key companies operating in the global Breast Cancer Predictive Genetic Testing market include , Roche, Thermo Fisher Scientific, PerkinElmer, Quest Diagnostics, Myriad Genetics, Iverson Genetics, Cancer Genetics, OncoCyte Corporation, NeoGenomics, Invitae Breast Cancer Predictive Genetic Testing

Key questions answered in the report:

For Discount, Customization in the Report: https://www.qyresearch.com/customize-request/form/1967056/global-breast-cancer-predictive-genetic-testing-market

TOC

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Breast Cancer Predictive Genetic Testing Revenue1.4 Market by Type1.4.1 Global Breast Cancer Predictive Genetic Testing Market Size Growth Rate by Type: 2020 VS 20261.4.2 High Penetrant Genes1.4.3 Intermediate Penetrant Genes1.4.4 Low Penetrant Genes1.5 Market by Application1.5.1 Global Breast Cancer Predictive Genetic Testing Market Share by Application: 2020 VS 20261.5.2 Hospitals1.5.3 Clinics1.5.4 Other1.6 Study Objectives1.7 Years Considered 2 Global Growth Trends2.1 Global Breast Cancer Predictive Genetic Testing Market Perspective (2015-2026)2.2 Global Breast Cancer Predictive Genetic Testing Growth Trends by Regions2.2.1 Breast Cancer Predictive Genetic Testing Market Size by Regions: 2015 VS 2020 VS 20262.2.2 Breast Cancer Predictive Genetic Testing Historic Market Share by Regions (2015-2020)2.2.3 Breast Cancer Predictive Genetic Testing Forecasted Market Size by Regions (2021-2026)2.3 Industry Trends and Growth Strategy2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Challenges2.3.4 Porters Five Forces Analysis2.3.5 Breast Cancer Predictive Genetic Testing Market Growth Strategy2.3.6 Primary Interviews with Key Breast Cancer Predictive Genetic Testing Players (Opinion Leaders) 3 Competition Landscape by Key Players3.1 Global Top Breast Cancer Predictive Genetic Testing Players by Market Size3.1.1 Global Top Breast Cancer Predictive Genetic Testing Players by Revenue (2015-2020)3.1.2 Global Breast Cancer Predictive Genetic Testing Revenue Market Share by Players (2015-2020)3.1.3 Global Breast Cancer Predictive Genetic Testing Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Breast Cancer Predictive Genetic Testing Market Concentration Ratio3.2.1 Global Breast Cancer Predictive Genetic Testing Market Concentration Ratio (CR5 and HHI)3.2.2 Global Top 10 and Top 5 Companies by Breast Cancer Predictive Genetic Testing Revenue in 20193.3 Breast Cancer Predictive Genetic Testing Key Players Head office and Area Served3.4 Key Players Breast Cancer Predictive Genetic Testing Product Solution and Service3.5 Date of Enter into Breast Cancer Predictive Genetic Testing Market3.6 Mergers & Acquisitions, Expansion Plans 4 Market Size by Type (2015-2026)4.1 Global Breast Cancer Predictive Genetic Testing Historic Market Size by Type (2015-2020)4.2 Global Breast Cancer Predictive Genetic Testing Forecasted Market Size by Type (2021-2026) 5 Market Size by Application (2015-2026)5.1 Global Breast Cancer Predictive Genetic Testing Market Size by Application (2015-2020)5.2 Global Breast Cancer Predictive Genetic Testing Forecasted Market Size by Application (2021-2026) 6 North America6.1 North America Breast Cancer Predictive Genetic Testing Market Size (2015-2020)6.2 Breast Cancer Predictive Genetic Testing Key Players in North America (2019-2020)6.3 North America Breast Cancer Predictive Genetic Testing Market Size by Type (2015-2020)6.4 North America Breast Cancer Predictive Genetic Testing Market Size by Application (2015-2020) 7 Europe7.1 Europe Breast Cancer Predictive Genetic Testing Market Size (2015-2020)7.2 Breast Cancer Predictive Genetic Testing Key Players in Europe (2019-2020)7.3 Europe Breast Cancer Predictive Genetic Testing Market Size by Type (2015-2020)7.4 Europe Breast Cancer Predictive Genetic Testing Market Size by Application (2015-2020) 8 China8.1 China Breast Cancer Predictive Genetic Testing Market Size (2015-2020)8.2 Breast Cancer Predictive Genetic Testing Key Players in China (2019-2020)8.3 China Breast Cancer Predictive Genetic Testing Market Size by Type (2015-2020)8.4 China Breast Cancer Predictive Genetic Testing Market Size by Application (2015-2020) 9 Japan9.1 Japan Breast Cancer Predictive Genetic Testing Market Size (2015-2020)9.2 Breast Cancer Predictive Genetic Testing Key Players in Japan (2019-2020)9.3 Japan Breast Cancer Predictive Genetic Testing Market Size by Type (2015-2020)9.4 Japan Breast Cancer Predictive Genetic Testing Market Size by Application (2015-2020) 10 Southeast Asia10.1 Southeast Asia Breast Cancer Predictive Genetic Testing Market Size (2015-2020)10.2 Breast Cancer Predictive Genetic Testing Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Breast Cancer Predictive Genetic Testing Market Size by Type (2015-2020)10.4 Southeast Asia Breast Cancer Predictive Genetic Testing Market Size by Application (2015-2020) 11 India11.1 India Breast Cancer Predictive Genetic Testing Market Size (2015-2020)11.2 Breast Cancer Predictive Genetic Testing Key Players in India (2019-2020)11.3 India Breast Cancer Predictive Genetic Testing Market Size by Type (2015-2020)11.4 India Breast Cancer Predictive Genetic Testing Market Size by Application (2015-2020) 12 Central & South America12.1 Central & South America Breast Cancer Predictive Genetic Testing Market Size (2015-2020)12.2 Breast Cancer Predictive Genetic Testing Key Players in Central & South America (2019-2020)12.3 Central & South America Breast Cancer Predictive Genetic Testing Market Size by Type (2015-2020)12.4 Central & South America Breast Cancer Predictive Genetic Testing Market Size by Application (2015-2020) 13 Key Players Profiles13.1 Roche13.1.1 Roche Company Details13.1.2 Roche Business Overview13.1.3 Roche Breast Cancer Predictive Genetic Testing Introduction13.1.4 Roche Revenue in Breast Cancer Predictive Genetic Testing Business (2015-2020))13.1.5 Roche Recent Development13.2 Thermo Fisher Scientific13.2.1 Thermo Fisher Scientific Company Details13.2.2 Thermo Fisher Scientific Business Overview13.2.3 Thermo Fisher Scientific Breast Cancer Predictive Genetic Testing Introduction13.2.4 Thermo Fisher Scientific Revenue in Breast Cancer Predictive Genetic Testing Business (2015-2020)13.2.5 Thermo Fisher Scientific Recent Development13.3 PerkinElmer13.3.1 PerkinElmer Company Details13.3.2 PerkinElmer Business Overview13.3.3 PerkinElmer Breast Cancer Predictive Genetic Testing Introduction13.3.4 PerkinElmer Revenue in Breast Cancer Predictive Genetic Testing Business (2015-2020)13.3.5 PerkinElmer Recent Development13.4 Quest Diagnostics13.4.1 Quest Diagnostics Company Details13.4.2 Quest Diagnostics Business Overview13.4.3 Quest Diagnostics Breast Cancer Predictive Genetic Testing Introduction13.4.4 Quest Diagnostics Revenue in Breast Cancer Predictive Genetic Testing Business (2015-2020)13.4.5 Quest Diagnostics Recent Development13.5 Myriad Genetics13.5.1 Myriad Genetics Company Details13.5.2 Myriad Genetics Business Overview13.5.3 Myriad Genetics Breast Cancer Predictive Genetic Testing Introduction13.5.4 Myriad Genetics Revenue in Breast Cancer Predictive Genetic Testing Business (2015-2020)13.5.5 Myriad Genetics Recent Development13.6 Iverson Genetics13.6.1 Iverson Genetics Company Details13.6.2 Iverson Genetics Business Overview13.6.3 Iverson Genetics Breast Cancer Predictive Genetic Testing Introduction13.6.4 Iverson Genetics Revenue in Breast Cancer Predictive Genetic Testing Business (2015-2020)13.6.5 Iverson Genetics Recent Development13.7 Cancer Genetics13.7.1 Cancer Genetics Company Details13.7.2 Cancer Genetics Business Overview13.7.3 Cancer Genetics Breast Cancer Predictive Genetic Testing Introduction13.7.4 Cancer Genetics Revenue in Breast Cancer Predictive Genetic Testing Business (2015-2020)13.7.5 Cancer Genetics Recent Development13.8 OncoCyte Corporation13.8.1 OncoCyte Corporation Company Details13.8.2 OncoCyte Corporation Business Overview13.8.3 OncoCyte Corporation Breast Cancer Predictive Genetic Testing Introduction13.8.4 OncoCyte Corporation Revenue in Breast Cancer Predictive Genetic Testing Business (2015-2020)13.8.5 OncoCyte Corporation Recent Development13.9 NeoGenomics13.9.1 NeoGenomics Company Details13.9.2 NeoGenomics Business Overview13.9.3 NeoGenomics Breast Cancer Predictive Genetic Testing Introduction13.9.4 NeoGenomics Revenue in Breast Cancer Predictive Genetic Testing Business (2015-2020)13.9.5 NeoGenomics Recent Development13.10 Invitae13.10.1 Invitae Company Details13.10.2 Invitae Business Overview13.10.3 Invitae Breast Cancer Predictive Genetic Testing Introduction13.10.4 Invitae Revenue in Breast Cancer Predictive Genetic Testing Business (2015-2020)13.10.5 Invitae Recent Development 14 Analysts Viewpoints/Conclusions 15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source15.2 Disclaimer15.3 Author Details

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Breast Cancer Predictive Genetic Testing Market 2020-2026: Key Vendor Landscape By Regional Output, Demand By Countries And Future Growth|Roche,...

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Human genetics, study of the inheritance of characteristics by children from parents. Inheritance in humans does not differ in any fundamental way from that in other organisms.

Britannica Quiz

Genetics Quiz

Which of these congenital disorders is characterized by an extra chromosome?

The study of human heredity occupies a central position in genetics. Much of this interest stems from a basic desire to know who humans are and why they are as they are. At a more practical level, an understanding of human heredity is of critical importance in the prediction, diagnosis, and treatment of diseases that have a genetic component. The quest to determine the genetic basis of human health has given rise to the field of medical genetics. In general, medicine has given focus and purpose to human genetics, so the terms medical genetics and human genetics are often considered synonymous.

A new era in cytogenetics, the field of investigation concerned with studies of the chromosomes, began in 1956 with the discovery by Jo Hin Tjio and Albert Levan that human somatic cells contain 23 pairs of chromosomes. Since that time the field has advanced with amazing rapidity and has demonstrated that human chromosome aberrations rank as major causes of fetal death and of tragic human diseases, many of which are accompanied by intellectual disability. Since the chromosomes can be delineated only during mitosis, it is necessary to examine material in which there are many dividing cells. This can usually be accomplished by culturing cells from the blood or skin, since only the bone marrow cells (not readily sampled except during serious bone marrow disease such as leukemia) have sufficient mitoses in the absence of artificial culture. After growth, the cells are fixed on slides and then stained with a variety of DNA-specific stains that permit the delineation and identification of the chromosomes. The Denver system of chromosome classification, established in 1959, identified the chromosomes by their length and the position of the centromeres. Since then the method has been improved by the use of special staining techniques that impart unique light and dark bands to each chromosome. These bands permit the identification of chromosomal regions that are duplicated, missing, or transposed to other chromosomes.

Micrographs showing the karyotypes (i.e., the physical appearance of the chromosome) of a male and a female have been produced. In a typical micrograph the 46 human chromosomes (the diploid number) are arranged in homologous pairs, each consisting of one maternally derived and one paternally derived member. The chromosomes are all numbered except for the X and the Y chromosomes, which are the sex chromosomes. In humans, as in all mammals, the normal female has two X chromosomes and the normal male has one X chromosome and one Y chromosome. The female is thus the homogametic sex, as all her gametes normally have one X chromosome. The male is heterogametic, as he produces two types of gametesone type containing an X chromosome and the other containing a Y chromosome. There is good evidence that the Y chromosome in humans, unlike that in Drosophila, is necessary (but not sufficient) for maleness.

A human individual arises through the union of two cells, an egg from the mother and a sperm from the father. Human egg cells are barely visible to the naked eye. They are shed, usually one at a time, from the ovary into the oviducts (fallopian tubes), through which they pass into the uterus. Fertilization, the penetration of an egg by a sperm, occurs in the oviducts. This is the main event of sexual reproduction and determines the genetic constitution of the new individual.

Human sex determination is a genetic process that depends basically on the presence of the Y chromosome in the fertilized egg. This chromosome stimulates a change in the undifferentiated gonad into that of the male (a testicle). The gonadal action of the Y chromosome is mediated by a gene located near the centromere; this gene codes for the production of a cell surface molecule called the H-Y antigen. Further development of the anatomic structures, both internal and external, that are associated with maleness is controlled by hormones produced by the testicle. The sex of an individual can be thought of in three different contexts: chromosomal sex, gonadal sex, and anatomic sex. Discrepancies between these, especially the latter two, result in the development of individuals with ambiguous sex, often called hermaphrodites. Homosexuality is unrelated to the above sex-determining factors. It is of interest that in the absence of a male gonad (testicle) the internal and external sex anatomy is always female, even in the absence of a female ovary. A female without ovaries will, of course, be infertile and will not experience any of the female developmental changes normally associated with puberty. Such a female will often have Turner syndrome.

If X-containing and Y-containing sperm are produced in equal numbers, then according to simple chance one would expect the sex ratio at conception (fertilization) to be half boys and half girls, or 1 : 1. Direct observation of sex ratios among newly fertilized human eggs is not yet feasible, and sex-ratio data are usually collected at the time of birth. In almost all human populations of newborns, there is a slight excess of males; about 106 boys are born for every100 girls. Throughout life, however, there is a slightly greater mortality of males; this slowly alters the sex ratio until, beyond the age of about 50 years, there is an excess of females. Studies indicate that male embryos suffer a relatively greater degree of prenatal mortality, so the sex ratio at conception might be expected to favour males even more than the 106 : 100 ratio observed at birth would suggest. Firm explanations for the apparent excess of male conceptions have not been established; it is possible that Y-containing sperm survive better within the female reproductive tract, or they may be a little more successful in reaching the egg in order to fertilize it. In any case, the sex differences are small, the statistical expectation for a boy (or girl) at any single birth still being close to one out of two.

During gestationthe period of nine months between fertilization and the birth of the infanta remarkable series of developmental changes occur. Through the process of mitosis, the total number of cells changes from 1 (the fertilized egg) to about 2 1011. In addition, these cells differentiate into hundreds of different types with specific functions (liver cells, nerve cells, muscle cells, etc.). A multitude of regulatory processes, both genetically and environmentally controlled, accomplish this differentiation. Elucidation of the exquisite timing of these processes remains one of the great challenges of human biology.

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human genetics | Description, Chromosomes, & Inheritance ...

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Scientists estimate that about 80 percent of an individuals height is determined by the DNA sequence variants they have inherited, but which genes these variants are in and what they do to affect height are only partially understood. Some rare gene mutations have dramatic effects on height (for example, variants in the FGFR3 gene cause achondroplasia, a rare condition characterized by short stature). For most individuals, though, height is controlled largely by a combination of genetic variants that each have more modest effects on height, plus a smaller contribution from environmental factors (such as nutrition). More than 700 such gene variants have been discovered and many more are expected to be identified. Some of these variants are in genes that directly or indirectly affect cartilage in growth plates, which are areas in the long bones of the legs and arms where new bone is produced, lengthening the bones as children grow. The function of many other height-associated genes remains unknown.

In addition to the FGFR3 gene, researchers have identified hundreds of other genes involved in rare disorders that have an extreme effect on height. These genes (and the conditions they are associated with) include FBN1 (acromicric dysplasia, geleophysic dysplasia, Marfan syndrome), GH1 (isolated growth hormone deficiency), EVC (Ellis-van Creveld syndrome, Weyers acrofacial dysostosis), and GPC3 (Simpson-Golabi-Behmel syndrome). By studying the dramatic effect that altered versions of these genes have on height, scientists hope to better understand the complex interactions among genes that contribute to normal height. Some genes, such as ACAN, contain rare variants that cause severe growth disorders, and also other variants with milder effects on height in individuals without a related health condition. Identifying other height genes, and variants with large or small effects, is an active area of genetic research.

Because height is determined by multiple gene variants (an inheritance pattern called polygenic inheritance), it is difficult to accurately predict how tall a child will be. The inheritance of these variants from ones parents helps explain why children usually grow to be approximately as tall as their parents, but different combinations of variants can cause siblings to be of different heights. Height is influenced by other biological mechanisms (such as hormones) that may also be determined by genetics, although the roles of these mechanisms are not fully understood.

In addition to genetic and biological determinants, height is also influenced by environmental factors, including the nutritional status of the mother during pregnancy, whether she smoked, and her exposure to hazardous substances. A well-nourished, healthy, and active child is likely to be taller as an adult than will be a child with a poor diet, infectious diseases, or inadequate health care. Socioeconomic factors such as income, education, and occupation can also influence height. In some cases, ethnicity plays a role in adult height, but studies on immigrant families have shown that moving to a country with better access to nutritious food, healthcare, and employment opportunities can have a substantial influence on the height of the next generation; this suggests that some differences in height between ethnicities are explained by non-genetic factors.

Lango Allen H, Estrada K, Lettre G, et al. Hundreds of variants clustered in genomic loci and biological pathways affect human height. Nature. 2010 Oct 14;467(7317):832-8. doi: 10.1038/nature09410. Epub 2010 Sep 29. PubMed: 20881960. Free full-text available from PubMed Central: PMC2955183.

Marouli E, Graff M, Medina-Gomez C, Lo KS, et al. Rare and low-frequency coding variants alter human adult height. Nature. 2017 Feb 9;542(7640):186-190. doi: 10.1038/nature21039. Epub 2017 Feb 1. PubMed: 28146470. Free full-text available from PubMed Central: PMC5302847.

McEvoy BP, Visscher PM. Genetics of human height. Econ Hum Biol. 2009 Dec;7(3):294-306. doi: 10.1016/j.ehb.2009.09.005. Epub 2009 Sep 17. PubMed: 19818695.

Perola M. Genome-wide association approaches for identifying loci for human height genes. Best Pract Res Clin Endocrinol Metab. 2011 Feb;25(1):19-23. doi: 10.1016/j.beem.2010.10.013. PubMed: 21396572.

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Is height determined by genetics? - Genetics Home ...

Recommendation and review posted by Bethany Smith