Mycobacteria, belonging to the genus Mycobacterium of the family Actinobacteriaceae, are immobile, rod-shaped, Gram positive bacteria. These bacteria can be divided into three groups for the purpose of diagnosis and treatment: Mycobacterium tuberculosis complex (MTBC), the causative pathogens of tuberculosis (TB); nontuberculous mycobacteria (NTM), with varying pathogenic potential; and Mycobacterium leprae, the causative pathogen of leprosy.Mycobacteria are widespread organisms, typically living in soil, water, animal tissue, and food sources, and can colonize their hosts without inducing any pathogenic signs or can cause latent infections that can lead to severe diseases. Although the genus Mycobacterium was first introduced in 1896, infections by MTBC organisms and NTM continue to challenge physicians and microbiologist across the globe. The unique cell wall characteristics of mycobacteria prevent them from being stained by the standard Gram stain procedure. Due to this acid-fastness, specific diagnostic tests are required such as auramine-rhodamine or Ziehl-Neelsen staining.

Differentiation between MTBC and NTM can be achieved by immunochromatography, but exact species identification requires more sophisticated techniques such as molecular diagnostics. The infections resulting from MTBC are difficult to treat due to intrinsic resistance to antibiotics like penicillin G, sulfonamides, tetracycline, erythromycin, and chloramphenicol. [1] Mycobacteria can survive exposure to acids, alkalis, detergents or oxidative bursts, but fortunately most NTM are susceptible to the antibiotics clarithromycin and rifamycin, although antibiotic resistant strains have also emerged, presenting a new threat to global public health.

The global TB epidemic

MTBC species include M. tuberculosis, M. bovis, M. affricanum, M. canetti, M. microti, and M. pinnipedii, with the most common TB-causing pathogen in humans considered to be M. tuberculosis. These pathogens are transmitted via droplet infection through the air by coughing, sneezing, and speaking. In high incidence countries, the risk of infection is greatly increased in densely populated areas, with infants and immunocompromised patients at heightened risk.

TB is one of the top 10 causes of death throughout the world and is the leading cause of death from a single infectious agent (above HIV/AIDS and malaria). In 2017, it was estimated that 10 million people per year developed the disease,[2] and approximately 1.7 billion people (23% of the worlds population) are estimated to have a latent TB infection and are therefore at risk of developing active TB disease during their lifetime.[3]

Early diagnosis and rapid, appropriate medication are needed to improve TB treatment success, which remains low at around 55% globally. Treatment efforts are also hampered by the persistence of drug-resistant TB strains. Recent estimates demonstrate that, in 2017, 558,000 people developed rifampicin-resistant TB (RR-TB) TB with resistance to the most effective first-line drug and that 82% of these cases were resistant to the second first-line drug, isoniazid, and are therefore described as multidrug-resistant TB (MDR-TB). [3] [4]

Closing the gap between detection and treatment requires more specific drug susceptibility testing among those diagnosed with TB. The therapy for MDR-TB is more time consuming and is characterized by more frequent and severe side effects. This has led to a lower compliance rate among treated patients, resulting in a further increase in drug resistances. If the infecting organism is resistant to the two first-line antibiotics (rifampicin and isoniazid) and at least one drug from each of the classes fluoroquinolones and second-line injectable agents (amikacin, capreomycin or kanamycin), it is classed as extensively drug-resistant (XDR)-TB. [5] Identifying the drug resistance pattern is therefore crucial to establishing a successful treatment plan to cure the patient and stop the transmission of resistant strains.

Challenges of mycobacteria detection

The distinction between TB and NTM is essential for diagnosis and treatment, and the course of action depends on the respective mycobacteria species. Genotypic (molecular) methods for species differentiation and resistance testing are valuable tools in TB and NTM diagnostics and offer considerable advantages compared with time-consuming conventional methods, such as biochemical testing and phenotypic resistance testing.

The process for identifying TB using traditional culture methods often takes 2-4 weeks for a positive result, and 6-8 weeks for a negative result (which then requires further testing) depending on whether solid or liquid media have been used. This is considerably slower compared with genetic testing, where identification for TB and NTM can be done in under 3 hours. Genetic testing offers a clear advantage for patients, as resistance patterns are available earlier for adequate treatment.

Additionally, there is no requirement for a laboratory to have biosafety level 3 laboratory (BSL3) credentials for molecular methods, because these tests can be performed from direct decontaminated samples. Via the direct sampling method, any laboratory can run genetic testing on samples to determine the presence or absence of M. tuberculosis and conduct further testing to identify NTM.

In May 2016, the World Health Organization (WHO) issued new recommendations on the use of a rapid diagnostic test the line probe assay (LPA) GenoType MTBDRsl to detect resistance to second-line anti-TB drugs (SL-LPA). [6] Compared with traditional culture-based techniques, LPAs are a more reliable method for ruling out resistance to the second-line antibiotics fluoroquinolones and the injectable drugs capreomycin, kanamycin and amikacin, enabling clinicians to set patients on the proper regime at the earliest time.

Detection of any second-line resistance by the SL-LPA means that MDR-TB patients should not be enrolled on the shorter regimen, as this could jeopardize their treatment outcome and fuel the development of XDR-TB. Patients detected with XDR-TB should also not be enrolled on the shorter regimen and require carefully designed individual regimens to optimize successful treatment.

Clinical impact of molecular testing

Professor Robert Warren, Unit Director and Chief Specialist Scientist, South African Medical Research Council (SAMRC), focuses his research on molecular epidemiology and has continually challenged assumptions related to TB.His findings have demonstrated that transmission of TB occurs largely outside of the household and that the drug resistance epidemic is driven by transmission, especially in previously treated patients, implying reinfection.

South Africa is considered the largest consumer of molecular diagnostic testing for TB, and in Cape Town alone, more than 15,000 LPAs are estimated to be carried out per year. Prof Warrens experience with this type of testing is extensive.

The picture in South Africa is very different in terms of the incidence of TB, explains Prof Warren, continuing: The country already had a high incidence rate but with the onset of HIV in the 1980s, this rapidly accelerated until our rates were among the highest in the world. The focus of our health system in the early 2000s was to halt the increase of drug-susceptible TB, but the downside of this is that drug-resistant TB got overlooked. Our figures now show that we appear to be on the downward trend for susceptible TB incidence, but now the focus needs to shift onto drug-resistant TB.

Molecular tools such as the SL-LPA have changed the landscape for testing in South Africa. Convincing physicians to move away from the traditional phenotypic testing to genetic testing was an initial barrier to the introduction of this method but once the benefits became clear, the adoption was swift.

Prof Warren describes his role in developing TB identification methods: At the research center, we have been responsible for evaluating the diagnostic tools that are available on the market before passing our findings to an independent panel, who then make recommendations to the Department of Health. From the work that we have carried out, the line-probe assay is now one of our most used testing methods for second-line TB identification.

The future for molecular testing in the area of TB, in my opinion, will need to focus on the low to middle income countries that dont have the necessary infrastructure in place for complex or specialized testing, explains Prof Warren. There are two different schools of thought here to develop a test that will deliver results against a defined set of drugs, or to develop a test that will provide results against a comprehensive set of drugs. Each solution has its place but either way, the test needs to be as simple as possible and the results easy for a lab technician to understand without specialist knowledge.

Future outlook for mycobacteria

The ability to optimize patient treatment by providing a rapid, reliable mycobacteria identification is improving health outcomes of TB and NTM infections worldwide. The future of TB and NTM testing is changing. As higher rates of TB are being detected in undeveloped countries where investment in laboratories and detection infrastructure is lower, the methods of testing need to be adjusted accordingly. There will be fewer trained technicians in these locations and molecular testing will need to become more intuitive to meet this throughput requirement.

The WHO recommendation of the SL-LPA molecular test to detect resistance to second-line anti-TB drugs indicates a step-change in the treatment of this disease. For these diagnostic tests to be applicable into the future, a more comprehensive outlook is required for assay development. In its End TB Strategy, the WHO has a shared vision of a world free of TB with zero deaths, disease and suffering by 2035.[3] This requires a 95% reduction in the absolute number of TB deaths and a 90% reduction in incidence rate compared with the 2015 baseline. Early diagnosis of TB, including universal drug-susceptibility testing and systematic screening of high-risk groups, will be a key component in achieving this target.

References

(1) Jarlier V and Nikaido H (1994) Mycobacterial cell wall: structure and role in natural resistance to antibiotics. FEMS Microbiol. Lett. 123:1118.

(2) Porvaznik I, Solovi I, Mokr J (2017) Non-Tuberculous Mycobacteria: Classification, Diagnostics, and Therapy. Adv Exp Med Biol, 944: 19-25.

(3) Tuberculosis (TB) Data & Statistics, Centers for Disease Prevention and Control (CDC), 2018, https://www.cdc.gov/tb/statistics/default.htm.

(4) TB Elimination: Extensively Drug-Resistant Tuberculosis (XRD TB), Fact Sheet, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), 2013, https://www.cdc.gov/tb/publications/factsheets/drtb/xdrtb.pdf.

(5) World Health Organization Global Tuberculosis Report 2018: https://www.who.int/tb/publications/global_report/en/

(6) The use of molecular line probe assays for the detection of resistance to isoniazid and rifampicin, Policy Update, World Health Organization, 2016, https://apps.who.int/iris/bitstream/handle/10665/250586/9789241511261-eng.pdf?sequence=1.

Read more:
Molecular Testing Closing the Gap Between TB Detection and Treatment - Technology Networks

Recommendation and review posted by Bethany Smith

When Oklahomas first confirmed case of COVID-19 was reported on March 6, there were already hundreds of cases nationwide and hot spots were beginning to emerge in other states. Not considered a priority by the federal government, Oklahoma was issued a minimal amount of the reagents necessary to run a coronavirus test.

Doctors were told to be selective in ordering tests for patients, reserving the limited supply for those with the most severe symptoms.

Tests were denied for some Oklahomans with mild symptoms who were left unsure if they were at risk of spreading the virus to others.

Oklahoma saw COVID-19 cases much later than other states and we were not getting as many government provided reagents as other states, said Kayse Shrum, Oklahomas secretary of science and innovation.

Hoping to find a way to increase the states testing capacity, Shrum called Elizabeth Pollard, an Edmond resident who had spent 25 years working in genetic testing and was in the process of building an infection control company in Silicon Valley.

Knowing that Oklahoma State Universitys diagnostic laboratory already had Thermo Fisher equipment, Pollard, who became the states deputy secretary of science and innovation earlier this year, called her contacts at the company and put Oklahoma in a position to order 10,000 COVID-19 test kits as soon they received FDA approval.

It was a match made in heaven, Pollard said about the OSU lab and Thermo Fisher.

Both Shrum and Pollard are key members of the governors coronavirus response team and have been central figures in crafting the states testing strategy, which has relied more on private companies than the federal government.

State and private labs have tested more than 13,000 Oklahomans a rate of 330 per 100,000 residents and the number of confirmed positive cases was at 1,327 on Monday.

Oklahomas rate is in the bottom third nationally, but if the state is going to significantly increase its testing in the coming days and avoid a future designation as a COVID-19 hotspot it will likely be because of Shrum and Pollard.

Shrum began appearing publicly with Gov. Kevin Stitt in mid March shortly after state epidemiologist Laurence Burnsed, who had been a participant in most media conferences with the governor, was abruptly replaced. Criticism toward state officials was intensifying as residents and health care officials complained of a lack of testing and mixed messaging.

Shrum has been described as a calm presence, a person who speaks with authority but not in complex terms, according to multiple people with knowledge of behind the scenes conversations.

Stitt embraced Shrums ability to communicate beyond scientific jargon and appreciated her perspective on other health consequences of the pandemic, including depression and suicide, according to multiple sources.

Stitt created a coronavirus response task force on March 15 that included Shrum, and because she was a liaison to the state medical community, the governor now had direct information from the frontlines of the pandemic.

She is a constant voice of science, wisdom, and experience, and an exceptional team player, said John Budd, Stitts chief operating officer and leader of the task force.

Budd said Shrum is working with Secretary of Health Jerome Loughridge to oversee the states plan to increase personal protective equipment for health care workers, ventilators, hospitals and ICU beds.

Shrum credits Pollard for helping Oklahoma compete with other states for testing kits from private labs at a time when a delayed response by federal leaders resulted in a shortage of tests available.

While testing is important to identify specific cases, inform individuals of the need to self isolate and give health care workers confirmation that they are treating a person with the virus, it is also valuable data in tracking the spread of COVID-19 and identifying local trends.

We just dont have enough testing to really see any specific trends yet, said David Holt, mayor of Oklahoma City, where there are nearly 500 confirmed cases in the citys metro.

But I think we have seen it get a lot better lately in the ability to do more tests locally, which will be key to better understand this.

While the state had a shortage of testing kits for most of March, it now has the ability to complete 2,800 tests each day, according to Shrum.

The number of tests performed by the state is likely to rise with more than 70 mobile testing sites throughout the state, a significant increase from the 16 in operation just a few days ago.

Last week, Stitt urged doctors to test anyone who has symptoms, such as a fever or shortage of breath. He also urged tests for those who have come in contact with another person who has tested positive for COVID-19.

The best way to slow the curve and stop the spread is more testing and tracing as well as continuing to practice social distancing, Stitt said last week.

Shrum said increasing the states testing capacity will be critical for modeling and creating a detailed response plan.

More testing means more clarity on what is happening in the community and it helps us project and look into the future, Shrum said.

While most of the nearly 13,000 tests have been run through private labs, which is where most doctors and clinics send their tests, state officials say it is important for the state labs to test more Oklahomans in order to better track trends.

The state labs are also free and can process results within a day.

Most private labs report a turnaround time of 24 to 48 hours, but that accounts for only the time tests are at a lab. Many private labs are out of state in larger markets, such as Dallas and Seattle, which can take multiple days of travel.

Pollard said Oklahoma continues to compete with other states for testing kits and resources but the state recently secured 15 Abbott testing machines, which can analyze a nasal swab in just a few minutes.

However, Abbott is selecting which states to send the necessary test kits with guidance from the Trump administration. Oklahoma has received only 100 of those kits.

We saw our first case later and there are states that are peaking faster than us and those are going to be the priority, Shrum said.

In addition to the state Department of Health and OSU labs, the University of Oklahoma lab could be receiving tests within the next week or two, according to officials.

While the state only has 100 kits for its quick response Abbott machines, the lab at OU is researching ways to develop its own kits that could be used.

Unlike genetic tests like the ones used in Thermo Fisher machines, most rapid tests detect protein antibodies, which can take about 10 days for infected people to develop.

While the antibody machines are not as accurate as genetic tests, they could be used to test individuals to determine if they have ever had the coronavirus, which would be valuable if its determined an infected person develops immunity.

State testing supplies were limited less than a month ago but Shrum said supply is no longer an issue, at least not right now.

Early on we had really pushed hard to say hospitalized health care workers and the vulnerable population were the only people who should be tested and I think our frontline professionals were listening, Shrum said.

But we have been able to scale very quickly and we are looking to do significantly more tests.

The Frontieris a nonprofit corporation operated by The Frontier Media Group Inc.

We are making critical coverage of the coronavirus available for free. Please consider subscribing so we can continue to bring you the latest news and information on this developing story.

Originally posted here:
The Frontier: Oklahoma's competition for coronavirus tests and the women leading the fight - Tahlequah Daily Press

Recommendation and review posted by Bethany Smith

We just had the pleasure of sitting down virtually with our amazing JSA Board Member, Elsa Pine, VP of Sales and Business Development at EdgeConneX to learn more about her recent journey with breast cancer, particularly during these trying times of the Covid-19 pandemic. May her story be a source of inspiration for our community, and provide hope during these difficult days.

Q: Lets begin with the great news first you just had very successful surgery. Let us know how you are recovering.

I am recovering well, and gaining my mobility quickly. My nerves are finally returning to my left side. And gratefully, my right side is back to normal!

I rode my bike with my son yesterday for quite a few miles!

My spiritual transformation had already begun before this surgery, so my mindset is in GO mode. For example, my iPhone music playlist is entitled LETS DO THIS!!.

Coming up, I have chemo and radiation, and we just got word that we are still full steam forward. My next surgery will be the laparoscopic removal of my ovaries, which will shut down the production of estrogen, to keep this cancer at bay.

I have been blessed to already have three amazing kids, so Im very lucky to have had these body parts and hormones serve their purpose. I will replace them with healing, for me and for others, like my very supportive family and friends.

Q: You also had genetic testing done at the time of your biopsy, why?

My amazing radiologist Dr. Susan Drossman was very surprised by a recent 3-D mammogram that didnt catch this fast-growing Lobular Carcinoma. During my biopsy, two out of seven needles bent, giving me a false response. Thank goodness that Dr. Drossman and her entire team make sure everyone also receives genetic testing with their biopsies.

Additionally, as my mom had battled with breast cancer twice twenty years ago, and therefore we had family history, Dr. Drossman also sent the tumor for additional testing to my Mount Sinais Dubin Center rockstar team, Dr. Elisa Port and Dr. Hannah Irie.

I received my results within ten days, and Ill never forget that call.

They tested over 84 genetic variants. I tested positive for BRCA2, a pathogen associated with autosomal dominant hereditary breast and ovarian cancer syndrome. As it turns out, my youngest sister (there are 3 girls in my family), who is 37-years-old, also has this BRCA2 mutation.

Additionally, my sisters Ancestry DNA Test also revealed our 14% Ashkenazi heritage. Certain genetic disorders are more common in Ashkenazi Jews. So although we never checked my dads side of the family previously, we realized we had breast cancer risk on both my mom and my dads side.

Q: What life changes did you make to prepare for surgery and for your healing? How did these measures make a positive impact for you?

I immediately changed to a plant-based diet, with lots of beet juice and carrot juice.

I also increased meditation to a few times per day, including a lot of walking meditation which has allowed me to connect even more with nature (birds, wind, trees, flowers). Its amazing when you are alone walking and not listening to music, how in tune with nature you can become (and it also helps to walk with my two dogs, Peyton and Brady).

In general, I am strengthening and nourishing my body as I prepare for the next steps on my path to healing.

Q: Knowing the world has changed for us all recently, how are you spending your days?

I walked into Mount Sinai West on 3/12 at 12:30 PM, with a planned surgery time of around 2 PM. When I finally came out of recovery at 10:30 PM, the world had changed.

I was in a private room, but I saw the fear in the staff and my husbands eyes. Something drastically shifted with the energy and I felt it strongly.

When I left the hospital on Saturday morning, the city was so quiet. It was eerie, and yet so peaceful at the same time.

Ive been in quarantine since 12/30/19, so adapting to these pandemic times was not new for me. I continue to work from home, burn palo santo a few times a day to air the rooms of germs, and also to help keep me calm.

Additionally, and like so many homes across this globe right now, we are burning candles and disinfecting surfaces, like light switches, door knobs, faucets, etc- anything my kids touch often.

My family and I are also preparing for chemo, which begins on 4/15, so very soon. I do have fears, as most chemo patients do, and these fears are multiplied due to Covid-19, but I am digging deep!

Q: What or who has inspired you the most this year?

I have to say, my Reiki Life Coach, Valisha Lasker, owner of Remedy 11, has inspired me to dig deeper into my own soul, to find comfort in love and in peace. She is a miracle worker with crystals, and has been guiding me through with empowering messages. Its been a wonderful experience to tap into the energy that is within me. I feel my energy moving freely now, not stuck, and able to not just heal me, but heal others.

Q: What are you most grateful for?

Im very grateful for my family, my amazing medical team, friends, colleagues, and Mother Earth. It is in nature that Im at my best, and she has taught me to be patient, pause, and just be present. I hope through all of this, we all learn to be a bit more patient and kinder to each other and to Mother Earth. It is through love that transformations happen, and mine is just beginning.

Ms. Elsa, we love you and we are praying for you. We are all sending you our biggest virtual hugs! Thank you for sharing your story and continuing to be a source of inspiration and strength for us. Namaste.

Read more:
Elsa's Story - JSA Advisory Board Member Update on her Battle with Breast Cancer During These Difficult Times - JSA

Recommendation and review posted by Bethany Smith

SALT LAKE CITY, April 08, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN), a global leader in personalized medicine, announced today that due to the impact of the global COVID-19 pandemic, the company is withdrawing its fiscal year 2020 financial guidance.

Prior to mid-March we were experiencing volume trends consistent with our expectations across all products; however, recent social distancing guidelines have had a significant impact on test volume trends in late March and into the fiscal fourth-quarter, said R. Bryan Riggsbee, interim president and CEO and chief financial officer at Myriad Genetics. Our priority as an organization during the coronavirus pandemic has been to maintain business continuity and access to testing, while ensuring the safety of our employees and customers. As an organization we have taken steps to advance these dual aims, and I am very proud of how the Myriad team has responded to the crisis.

In responding to the pandemic, Myriad has made several changes to its business practices to promote the safety of both customers and employees including ceasing in-office sales calls and implementing virtual selling, granting all non-essential personnel the ability to work from home, enabling direct sample collection for patients and implementing policies to improve laboratory personnel safety.

While the uncertain timeframe of the Coronavirus pandemic makes it difficult to predict future business trends for the company, the company will provide an update on its business, including the impact of COVID-19, on its next quarterly earnings call.

About Myriad GeneticsMyriad Genetics, Inc. is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra, Prequel, ForeSight, GeneSight and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to maintaining the Companys global leadership in precision medicine and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's present 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 described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of the Companys existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to the Companys ability to successfully transition from its existing product portfolio to our new tests; risks related to changes in the governmental or private insurers reimbursement levels for the Companys tests or the Companys ability to obtain reimbursement for its new tests at comparable levels to its existing tests; risks related to increased competition and the development of new competing tests and services; the risk that the Company may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that the Company may not successfully develop new markets for its molecular diagnostic tests and pharmaceutical and clinical services, including the Companys ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying the Companys molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating the Companys laboratory testing facilities; risks related to public concern over the Companys genetic testing in general or the Companys tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to the Companys ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to the Companys ability to successfully integrate and derive benefits from any technologies or businesses that it licenses or acquires; risks related to the Companys projections about the potential market opportunity for the Companys products; the risk that the Company or its licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying the Companys tests; the risk of patent-infringement claims or challenges to the validity of the Companys patents; risks related to changes in intellectual property laws covering the Companys molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that the Company may be unable to comply with financial operating covenants under the Companys credit or lending agreements; the risk that the Company will be unable to pay, when due, amounts due under the Companys credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of the Companys most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in the Companys Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

Story continues

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Myriad Withdrawing Financial Guidance for FY2020 Due to Business Impact from Coronavirus Pandemic - Yahoo Finance

Recommendation and review posted by Bethany Smith

Pre-implantation genetic diagnosis is the genetic profiling of embryos prior to implantation, and sometimes even of oocytes prior to fertilization. PGD is considered in a similar fashion to prenatal diagnosis

Get Sample Copy of This Report @ https://www.orianresearch.com/request-sample/1374539

The global preimplantation genetic testing market was estimated to be valued at USD XX million in 2019 and is projected to reach USD XX million by 2026, at a CAGR of XX% during 2020 to 2026. Rising number of fertility clinics worldwide market are the factors supporting the market growth globally. However, high procedural cost associated with preimplantation genetic testing is expected to hamper the growth of the global market.

The global preimplantation genetic testing market is segmented based on procedure type, technology, and region. Based on procedure type, it is divided into preimplantation genetic screening, preimplantation genetic diagnosis. Based on technology, it is categorized next-generation sequencing, polymerase chain reaction, fluorescence in situ hybridization, comparative genomic hybridization, single-nucleotide polymorphism. Region wise, it is analyzed across North America, Europe, Asia-Pacific, South America, and MEA.

On the basis of procedure type, the market is split into:* Preimplantation Genetic Screening* Preimplantation Genetic Diagnosis

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On the basis of technology, the market is split into:* Next-Generation Sequencing* Polymerase Chain Reaction* Fluorescence in Situ Hybridization* Comparative Genomic Hybridization* Single-Nucleotide Polymorphism

Moreover, the market is classified based on regions and countries as follows:* North America- U.S., Canada* Europe- U.K., France, Germany, Italy and Rest of Europe* Asia-Pacific- China, Japan, India and Rest of Asia Pacific* South America- Brazil, Mexico and Rest of South America* Middle East & Africa- South Africa, Saudi Arabia and Rest of Middle East & Africa

Key Market Players:The key players profiled in the market include:* Illumina, Inc.* Thermo Fisher Scientific Inc.* Agilent Technologies, Inc.* Perkinelmer, Inc.* Coopersurgical, Inc. (A Subsidiary of the Cooper Companies, Inc.)* ABBott Laboratories* Natera, Inc.* Rubicon Genomics (A Subsidiary of Takara Bio USA Holdings, Inc.)* Oxford Gene Technology* Yikon Genomics

These enterprises are focusing on growth strategies, such as new product launches, expansions, acquisitions, and agreements & partnerships to expand their operations across the globe.

Key Benefits of the Report:* Global, regional, country, procedure type, technology and market size and their forecast from 2015-2026* Identification and detailed analysis on key market dynamics, such as, drivers, restraints, opportunities, and challenges influencing growth of the market* Detailed analysis on industry outlook with market specific PESTLE, and supply chain to better understand the market and build expansion strategies* Identification of key market players and comprehensively analyze their market share and core competencies, detailed financial positions, key products, and unique selling points* Analysis on key players strategic initiatives and competitive developments, such as joint ventures, mergers, and new product launches in the market* Expert interviews and their insights on market shift, current and future outlook, and factors impacting vendors short term and long term strategies* Detailed insights on emerging regions procedure type, technology, with qualitative and quantitative information and facts

Inquire more or share a question if any before the purchase on this report @ https://www.orianresearch.com/enquiry-before-buying/1374539

Target Audience:* Preimplantation Genetic Testing Device Manufacturers* Traders, Importers, and Exporters* Raw Material Suppliers and Distributors* Research and Consulting Firms* Government and Research Organizations* Associations and Industry Bodies

Research Methodology:The market is derived through extensive use of secondary, primary, in-house research followed by expert validation and third party perspective, such as, analyst reports of investment banks. The secondary research is the primary base of our study wherein we conducted extensive data mining, referring to verified data sources, such as, white papers, government and regulatory published articles, technical journals, trade magazines, and paid data sources.

For forecasting, regional demand & supply factors, recent investments, market dynamics including technical growth scenario, consumer behavior, and end use trends and dynamics, and production capacity were taken into consideration. Different weightages have been assigned to these parameters and quantified their market impacts using the weighted average analysis to derive the market growth rate.

The market estimates and forecasts have been verified through exhaustive primary research with the Key Industry Participants (KIPs), which typically include:* Manufacturers* Suppliers* Distributors* Government Body & Associations* Research InstitutesAbout UsOrian Research is one of the most comprehensive collections of market intelligence reports on the World Wide Web. Our reports repository boasts of over 500000+ industry and country research reports from over 100 top publishers. We continuously update our repository so as to provide our clients easy access to the worlds most complete and current database of expert insights on global industries, companies, and products. We also specialize in custom research in situations where our syndicate research offerings do not meet the specific requirements of our esteemed clients.Contact Us:Ruwin MendezVice President Global Sales & Partner RelationsOrian Research ConsultantsUS: +1 (415) 830-3727 | UK: +44 020 8144-71-27Email: [emailprotected]

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Global Preimplantation Genetic Testing Market Size, by Procedure Type (Preimplantation Genetic Screening), by Technology (Next-Generation Sequencing,...

Recommendation and review posted by Bethany Smith

Global Predictive Genetic Testing market research report offers a complete analysis of the market size, market segmentation, and market growth factors. In addition, the Predictive Genetic Testing market report comprises the momentous data about the market drivers, restraints, and various factors such as changing manufacturing costs, research and development expenses, and operational difficulties. Moreover, the Predictive Genetic Testing research report delivers a broad study regarding the development in economic growth, technological advancements, as well as an extensive valuation of the technology providers.

Top Leading Key Players are: Agilent, Technologies, Inc., BGI Genomics, F.Hoffman-La Roche Ltd., Genes In Life., Invitae Corporation, Illumina, Inc., 23andMe, Myriad Genetics, Inc., Pathway Genomics and Thermo Fisher Scientific, Inc.

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In addition, report on global Predictive Genetic Testing market presents strategic analysis and ideas for new entrants using historic data study. Thus report provides estimation about the market size, revenue, sales analysis and opportunities based on the past data for current and future market status. Report covers analysis of different enterprises as part of global Predictive Genetic Testing market. There are some important tools for any market movement. Also report forecasts the market size of global Predictive Genetic Testing market in Compound Annual Growth Rate in terms of revenue during the forecast period.

The company profiles also covers the detailed description and segmentation of the companies along the finances which are being covered for the company. The global Predictive Genetic Testing market is likely to provide insights for the major strategies which is also estimated to have an impact on the overall growth of the market. Several strategies such as the PESTEL analysis and SWOT analysis is also being covered for the global market. These strategies have an impact on the overall market. Furthermore, several factors such as the emergence of new opportunities is also likely to boost the growth of the market.

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Likewise, the study also analyses numerous factors that are influencing the Predictive Genetic Testing market from supply and demand side and further evaluates market dynamics that are impelling the market growth over the prediction period. In addition to this, the target market report provides inclusive analysis of the SWOT and PEST tools for all the major regions such as North America, Europe, Asia Pacific, and the Middle East and Africa. The report offers regional expansion of the industry with their product analysis, market share, and brand specifications. Furthermore, the Predictive Genetic Testing market study offers an extensive analysis of the political, economic, and technological factors impelling the growth of the global Predictive Genetic Testing market across these economies.

A qualitative and quantitative analysis of the Predictive Genetic Testing market valuations for the expected period is presented to showcase the economic appetency of the global Predictive Genetic Testing industry. In addition to this, the global research report comprises significant data regarding the market segmentation which is intended by primary and secondary research methodologies. This research report offers an in-depth analysis of the global Predictive Genetic Testing industry with recent and upcoming market trends to offer the impending investment in the Predictive Genetic Testing market. The report includes a comprehensive analysis of the industry size database along with the market prediction for the mentioned forecast period. Furthermore, the Predictive Genetic Testing market research study offers comprehensive data about the opportunities, key drivers, and restraints with the impact analysis.

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Global Predictive Genetic Testing Market Size, Share, Types, Products, Trends, Growth, Applications and Forecast 2020 to 2025 - Germany English News

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Niche players in the global gene therapy market must leverage greater government expenditure and upgrade their existing infrastructure along with expanding their gene therapy centers for sustaining their market hegemony.

ROCKVILLE, MD / ACCESSWIRE / April 8, 2020 / Global gene therapy market is poised for robust growth with net revenue pool set to exceed approximately US$ 5 Bn by 2026 end. The market is receiving tailwinds from advancements in synthetic biology. On that premise, the gene therapy market will expand 3X through over the forecast period, projects Fact.MR (2020-2026).

"Certain types of cancer such as Diffuse Large B-cell Lymphoma (DLBCL) and lymphoblastic leukemia are contributing to high mortality rates across the world. Gene therapy is gaining increasing recognition in its immense potential for treating rare diseases. Continued research and development in the area of gene therapy is supporting market growth as well," states Fact.MR.

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Gene Therapy Market - Key Findings

Gene Therapy Market - Key Driving Factors

Explore 59 tables and 79 figures of the study. Request TOC of the report at-

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Gene Therapy Market - Key Restraints

Impact of COVID-19 on Gene Therapy Market

In view of ongoing onslaught of COVID-19 pandemic, the focus of major healthcare authorities of the world has gravitated towards developing vaccines for the deadly respiratory disease. Gene therapy is one such area of research which could help boost antibodies required to treat patients infected with Coronavirus. For instance, Generation Bio is exploring the potential role of gene therapy in treating COVID-19 patients. Hence, the global gene therapy market will benefit from the outbreak in that market players are rushing to develop multiple therapeutic approaches for SARS-CoV-2. Growing fears of similar Coronavirus outbreaks in the future will continue accelerating the development of gene therapy as well.

Competitive Landscape

Prominent players profiled in this Fact.MR study include, but are not limited to, Orchard Therapeutics Limited, CELGENE CORPORATION, Spark Therapeutics, Inc., Sibiono GeneTech Co. Ltd., Spark Therapeutics Inc., Gilead Sciences Inc., and Novartis AG. Developed regions remain the key focus area of major stakeholders in the global gene therapy market. Existing gene therapy centers are being prioritized by market players in order to utilize the full extent of their resources. Moreover, they are benefitting from success rates associated with gene therapy and faster drug approvals. Gilead Sciences Inc. expanded their gene therapy centers to a total of 90 recently.

About the Report

This 170-page study offers in-depth commentary on the gene therapy market. The study provides compelling insights on the gene therapy market on the basis of product (yescarta, kymriah, luxturna, strimvelis, and gendicine), application (ophthalmology, oncology, Adenosine Deaminase Deficiency- Severe Combined Immunodeficiency) across three regions (The United States, Europe, and Rest of the World).

Explore Fact.MR's Comprehensive Coverage on Healthcare Landscape

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Gene Therapy Market Set for 3X Expansion Between 2020 and 2026; COVID-19 Stimulating Development of Multiple Therapeutic Approaches: Fact.MR - Yahoo...

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A group of Korean researchers said they have confirmed a gene responsible for inherited retinal disorders (IRD) among Koreans.

IRD is a combination of several rare diseases that usually develops at a young age and progresses slowly over the lifetime. The patients gradually lose their sight, and most of them eventually lose their vision entirely due to continuous retinal cell degeneration.

The Seoul National University Bundang Hospital (SNUBH) Department of Ophthalmology and Seoul National University Hospital (SNUH) Department of Laboratory Medicine jointly conducted the study.

Currently, antioxidant therapy, artificial retinal transplantation, and stem cell therapy are being used to treat the disorder regardless of mutations, but the only viable treatment is gene therapy. Even when gene therapy is possible, only less than 1 percent of all IRD patients can be treated with it.

In the West, genetic abnormalities of these retinal diseases have been studied and known well. However, researches on Korean cases are still lacking, and the joint research team tackled the subject to find the causative gene for IRDs with 86 domestic patients, the team said in a news release on Wednesday.

The team studied and identified the gene responsible for the disorders by using the latest technique of gene analysis with the most number of patients who have been reported so far.

The study revealed that only 44 percent of the patients, 38 out of 86, possessed the causal gene for IRDs. Even among the patients with retinitis pigmentosa, the most common disorder among the IRDs, only 41 percent had the causative gene.

The causative genes could be quite diverse even in the same disorder. The patients can find a responsible gene only when they receive genetic counseling very actively and can receive gene counseling, too, the research team explained.

Differences were found in the type and frequency of causal gene mutations between Korean and Western cases. However, there were similarities between those of Korean and other Asian nations, including Japan.

The research and diagnosis environment for IRDs has been very poor until now, and our study has significance as a basic data for diagnosis and treatment for Korean patients with IRDs, SNUH Department of Ophthalmology Professor Woo Se-joon said.

Patients need to receive causal gene tests actively to provide the domestic medical communities with sufficient data, and a list of patients who can be treated. By doing so, clinical trials and new drug development in gene therapy will progress smoothly, he added.

Previously, only a few hospitals could diagnose the causative gene for IRDs and afford to test and treat IRD patients due to the high cost of genetic testing. Recently, however, the chance of diagnosis has increased as more hospitals are conducting genetic tests amid the lowered cost thanks to insurance benefits.

Also, the therapeutic opportunity for IRD patients is likely to get broadened, as the retinal pigment epithelium 65 gene (RPE65) therapy won approval from the U.S. Food and Drug Administration for the first time in the world.

Although we do not have a clear way to prevent IRDs at the moment, the prediction of risk and their early detection are developing through the discovery of family history and causative genes, Professor Woo said. Early diagnosis can prevent impaired vision by gene therapy and vision correction, and the patients will be able to choose appropriate jobs with social activities.

Also taking part in the research team were Professors Joo Kwang-sic and Park Kyu-hyung of SNUBH and Professors Seong Moon-woo and Park Sung-sup of SNUH.

The results of this study were published in the Journal of Korean Medical Science.

shim531@docdocdoc.co.kr

< Korea Biomedical Review, All rights reserved.>

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SNUH team finds causal gene of inherited retinal disorder - Korea Biomedical Review

Recommendation and review posted by Bethany Smith

"The rise in Market Size is due to an increasing incident population of Multiple Myeloma patients in the 6MM, along with expected entry of premium price asset which will have an impact on market size"

LAS VEGAS, April 8, 2020 /PRNewswire/ -- DelveInsight has announced an addition of a new market research report on "CAR T-Cell Therapy for Multiple Myeloma Market Insights and Market Forecast-2030" to its offerings.

The report offers in-depth CAR T-Cell Therapy for Multiple Myeloma Market Analysis, 11 years Market Size Forecast, detailed Epidemiology analysis and 11-year Forecast, Emerging Drugs Market Uptake and information related to Leading Companies along with the Competitive Analysis edge.

Some key highlights from the report

:

Click here to getCAR T-Cell Therapy for Multiple Myelomamarket sample pages: https://delveinsight.com/sample-request/car-t-cell-therapy-for-multiple-myeloma-market

Chimeric Antigen Receptor (CAR) T-cell therapy is a technique that involves genetic modification of patient's autologous T-cells for CAR expression, specific for a tumor antigen, followed by ex-vivo cell expansion and re-infusion back to the patient.

Chimeric Antigen Receptor T-cells are the fusion proteins of a selected single-chain fragment that are the variable from a specific monoclonal antibody and one or more T-cell receptor intracellular signaling domains. T-cell genetic modification may occur either through viral-based gene transfer methods or non-viral methods like DNA-based transposons, CRISPR/Cas9 technology, zinc finger nuclease (ZFN), transcription activator-like effector nuclease (TALEN), or direct transfer of in vitro transcribed-mRNA by electroporation.

CAR T-Cell Therapy for Multiple Myeloma Treatment Market

According to WHO, in the year 2018, 159,985 incident cases of multiple myeloma were reported in the world. Multiple myeloma is a rare type of cancer that develops in plasma cells. The patients diagnosed with Multiple Myeloma have cancer cells that eventually supersede the healthy plasma cells. This process exhausts the much-needed white blood cells in the body.

A cure for Multiple Myeloma currently is not available. However, significant research is making progressive leaps toward a Multiple Myeloma treatment that eliminates the disease entirely. Some of them are enumerated below:

Targeted therapy: Targeted drug treatment targets on specific abnormalities within cancer cells that enables them to survive. The drugs like Bortezomib (Velcade), carfilzomib (Kyprolis) and ixazomib (Ninlaro), which may be administered through a vein in the arm or in pill form, block the action of a substance in myeloma cells that breaks down proteins. Eventually, it leads to the myeloma cells to die.

Biological therapy: Biological therapy drugs use body's immune system to kill myeloma cells. The drugs like thalidomide (Thalomid), lenalidomide (Revlimid) and pomalidomide (Pomalyst) improve the immune system cells to identify and fight cancer cells. These medications are usually taken in pill form.

Chemotherapy: Chemotherapy drugs kill fast-growing cells like myeloma cells. Chemotherapy drugs can be administered through a vein in the arm or taken in pill form.

Corticosteroids: Prednisone and dexamethasone regulate the immune system to control inflammation in the body. They are also active against myeloma cells. Corticosteroids can be taken in pill form or administered through a vein in patient's arm.

Story continues

Radiation therapy: This treatment uses beams of energy, such as X-rays and protons, to kill myeloma cells and prohibit their growth. Radiation therapy may be used to swiftly shrink myeloma cells in a specific area.

Several biotechnological companies that are working towards the development of therapies and will impact CAR T-Cell Therapy for Multiple Myeloma treatment market scenario in the upcoming years.

Drugs covered in the report are:-

And many others

TheCAR T-Cell Therapy for Multiple Myeloma Market Key Players are:-

And many others

Scope of the report:

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Insight covered regarding Reimbursement Scenario in Multiple Myeloma CAR T-Cell Therapy

Approaching reimbursement can have a positive influence on both during the late stages of product development and after product launch. In report, reimbursement is taken into consideration to identify economically attractive indications and market opportunities. When working with limited resources, the ability to choose the markets with the fewest reimbursement barriers can be a critical business & price strategy.

KOL- Views

To keep up with current market trends, KOLs and SME's opinions, working in CAR T-Cell Therapy for Multiple Myeloma domain are taken into account through primary research to fill the data gaps and validate the secondary research. Their opinion assist to comprehend and validate current and emerging therapies treatment patterns and Multiple Myeloma market trend. This will benefit the clients in potential upcoming novel CAR T-Cell Therapy for Multiple Myeloma treatment by recognizing the overall scenario of the market and the unmet needs.

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Reasons to buy

Key Topics Covered:

1

Key Insights

2

Executive Summary

3

CAR T-Cell Therapy Market Overview at a Glance

4

CAR T-Cell Therapy Background and Overview

5

CAR T-Cell Therapy for Multiple Myeloma (MM): 6 Major Market Analysis

6

CAR T-Cell Therapy Market Outlook

7

CAR T-Cell Therapy Emerging Drug Profiles for Multiple Myeloma

7.1

bb2121: Celgene Corporation

7.2

JNJ-68284528 (LCAR-B38M): Janssen Research & Development

7.3

P-BCMA-101: Poseida Therapeutics

7.4

CAR-CD44v6: MolMed S.p.A.

7.5

JCARH125 (Orvacabtagene autoleucel): Celgene Corporation

7.6

Descartes-08: Cartesian Therapeutics

7.7

CT053 : CARsgen Therapeutics)

7.8

PBCAR269A: Precision BioSciences

8

United States Market Size

9

EU-5 Market Size

9.1

Germany

9.2

France

9.3

Italy

9.4

Spain

9.5

United Kingdom

10

CAR T-Cell Therapy Clinical Trials in 6MM

11

KOL Views CAR T-Cell Therapy

12

CAR T-Cell Therapy for Multiple Myeloma Market Drivers

13

CAR T-Cell Therapy for Multiple Myeloma Market Barriers

14

Appendix

15

DelveInsight Capabilities

16

Disclaimer

17

About DelveInsight

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About DelveInsight

DelveInsight is a leading Business Consultant, and Market Research Firm focused exclusively on life sciences. It supports pharma companies by providing end to end comprehensive solutions to improve their performance.

Related Reports:-

DelveInsight's "CAR T-Cell Therapy for Acute Lymphoblastic Leukemia (ALL) Market Insights and Market Forecast- 2030" report delivers an in-depth understanding of the CAR T-Cell Therapy use for Acute Lymphoblastic Leukemia as well as the CAR T-Cell Therapy market trends for Acute Lymphoblastic Leukemia in the 6MM i.e., United States and EU5 (Germany, Spain, Italy, France and the United Kingdom).

DelveInsight's 'CAR T-Cell Therapy for Non-Hodgkin's lymphoma Market Insights and Market Forecast-2030' report delivers an in-depth understanding of the CAR T-Cell Therapy for Non-Hodgkin's lymphoma and market trends in the 6MM, i.e., United States and EU5 (Germany, Spain, Italy, France and United Kingdom).

Contact us:Shruti Thakurinfo@delveinsight.com+91-9650213330DelveInsight

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Market Size of CAR T-Cell Therapy for Multiple Myeloma in the 6MM is Expected to Be USD 3,766.4 Million in 2030 | Some of the Major Players Involved...

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A genetic variant in a gene called MET is responsible for more aggressive growth of head and neck cancer, and lung cancer, according to a new study.

A further probe into the finding reveals therapeutic strategies that could potentially target this genetic alteration and pave the way for better and more effective treatments.

The MET gene encodes for a cancer promoting protein that relays growth, survival, and transmission of signals in cancer cells, researchers say.

As reported in Nature Communications, researchers also identified a form of MET protein which showed ethnic preference with higher incidence among Asians, and associated with poorer prognosis in patients diagnosed with head and neck squamous cell carcinoma or lung squamous cell carcinoma.

Even though the MET variant does not seem to predispose someone to head and neck cancer or lung cancer, it leads to more aggressive growth of cancers that have already developed.

Unlike other MET mutants, existing MET-blocking drugs do not seem to inhibit this genetic variant, prompting researchers to conduct further investigation on the mechanism behind the genetic alteration.

The team found that the single amino-acid change in the MET receptor from the genetic alteration leads to preferential strong binding to another cancer promoting protein, HER2. Both proteins then work together to drive cancer aggression and allow the cancer cells to survive therapies that involve MET-blocking drugs.

The mechanism of this MET variant is novel and unreported. This finding contributes to the growing evidence of the role of genetic variants in affecting clinical outcome, and underscores the importance of diving deep into our genetic inheritance in cancer research, says Kong Li Ren of the Cancer Science Institute (CSI) Singapore at NUS, who initiated the study.

Knowledge of this unique mechanism also allowed researchers to identify several HER2 inhibitors capable of blocking cancer progression the genetic alteration caused.

Our study represents a conceptual advancement to cancer research, as we have shown that it is possible to block the activity of a cancer-driving gene by administrating a targeted therapy directed not against the mutant protein in question, but rather, a corresponding protein with which it binds to, says Goh Boon Cher, deputy director and senior principal investigator at CSI Singapore.

The remarkable anti-tumor responses observed in our experimental models, coupled with the availability of FDA-approved HER2 inhibitors, also presents a huge opportunity for clinicians to improve disease outcome of this genetic alteration via precision medicine.

The research team is now translating the findings to a clinical trial where patients tested positive for this MET variant gene are treated with suitable medications that have shown effectiveness in the laboratory.

Additional coauthors are from the National University Cancer Institute, the National Cancer Centre Singapore, and the Bioinformatics Institute at the Agency for Science, Technology and Research, Singapore.

Source: National University of Singapore

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Gene variant makes head and neck cancer more aggressive - Futurity: Research News

Recommendation and review posted by Bethany Smith

The two firms plan to leverage Orgenesiss autologous Cell and Gene Therapy Biotech Platform to produce muscle-derived mesenchymal stem cells (mdMSC) as a source of exosomes

Inc () is teaming up with regenerative medicine and cell therapy firm RevaTis on a new joint venture to produce certain stem cells for therapeutic use, it said Wednesday.

The two firms plan to leverage Orgenesiss autologous Cell and Gene Therapy (CGT) Biotech Platform to develop novel therapies and advance clinical trials.

Under the agreement, RevaTis and Orgenesis will use the formers patented technique to obtain muscle-derived mesenchymal stem cells (mdMSC) as a source of exosomes and various other cellular products.

Orgenesis and RevaTis are hoping to build on RevaTiss early success in animals to develop therapies and advance human trials using Orgenesiss expertise and Point-of-Care platform, which include automated systems, 3D printing and bioreactor technologies.

RevaTiss technologies are highly differentiated and ideally suited for Orgenesiss CGT Biotech Platform, Orgenesis CEO Vered Caplan told shareholders.

We believe that this exclusive partnership with RevaTis further validates the significant value proposition of the Orgenesis vertically integrated business model, Caplan said in a statement Wednesday.

This model allows us to streamline the entire process of therapeutic development and delivery of cell therapies within the patient care setting through our Cell & Gene Biotech Platform.

RevaTis also has existing partnerships with research institutions in the US, the Middle East and India that will be highly complementary to Orgenesiss POCare Network, according to Caplan. We look forward to utilizing the Orgenesis Cell & Gene Biotech Platform with a goal to lower the costs and accelerate the timeline of bringing these innovative therapies through the clinic and potentially into commercialization.

RevaTis CEO Didier Serteyn said the firm was delighted to partner with Orgenesis on the new venture.

We selected Orgenesis as a result of their extensive experience in the field of autologous cell therapies, including technical, clinical and regulatory expertise, Serteyn said in a statement. We expect that this will be valuable as we aim to advance our platform through commercialization.

Germantown, Maryland-based Orgenesis is a vertically integrated biopharmaceutical company with expertise in developing advanced cell therapies and manufacturing.

Shares of Orgenesis jumped 5.8% on Wednesday to reach $4.40 by midday.

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Orgenesis partners with Belgium"s RevaTis to develop stem cells for therapeutic use - Proactive Investors USA & Canada

Recommendation and review posted by Bethany Smith

MARTINSRIED, Germany--(BUSINESS WIRE)--SIRION Biotech GmbH announced today that Beam Therapeutics licensed rights to use SIRION Biotechs LentiBOOST for use in their CAR-T cell products.

CAR-T cell therapy represents a promising and future-defining shift in cancer treatment. Beam Therapeutics is developing a new generation of CAR-T product candidates using its proprietary base editing technology.

Under the terms of this agreement, SIRION agreed to provide Beam with non-exclusive access to its proprietary lentiviral transduction enhancer LentiBOOST for clinical development and commercialization of Beams portfolio of CAR-T programs. SIRION will be entitled to undisclosed upfront and milestone payments and is eligible to receive royalties on future product net sales plus license fees tied to commercial success.

Dr. Christian Thirion, CEO and founder of SIRION Biotech GmbH explains: LentiBOOST was engineered to improve lentiviral transduction of difficult cell types like T-cells and hematopoietic stem cells. This technology enables robust upscaling of the T-cell production process, and helps to reduce manufacturing costs by lowering the amount of lentiviral vectors needed for production of the cell product while at the same time improving clinical efficacy by increasing vector copy numbers (VCN) per cell. We are delighted that the LentiBOOST technology may help Beam further enhance the clinical success of its CAR-T pipeline.

LentiBOOST is used in an increasing number of clinical trials in the US and in Europe and the technology is more and more considered as a gold standard in manufacturing of cell products. Our non-exclusive licensing strategy makes our technology available to a wide range of companies and research hospitals to boost the efficiency of their various clinical programs, says SVP of Business Development & Licensing, Dr. Sabine Ott.

About SIRION Biotech GmbH

SIRION Biotech was founded in 2005 to lead the next generation of viral vector technologies for gene and cell therapy as well as vaccine development. Now SIRION offers one of the worlds most comprehensive viral vector technology platforms based on lenti-, adeno-, and adeno-associated viruses which expedites gene therapy research and advances drug development. SIRION is becoming a partner of choice in this growing sector. LentiBOOST has been used in a number of clinical trials from early stage clinical Phase 1/2 through late stage clinical Phase 3 trials and demonstrated clinical success in improving transduction of the therapeutic vector.

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Beam Therapeutics Licenses SIRION Biotech's LentiBOOST Technology for its CAR-T pipeline - Business Wire

Recommendation and review posted by Bethany Smith

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After more than 20 years of research, we are now witnessing a breakthrough of small interfering RNA (siRNA)-based therapies. In 2018, the first-ever siRNA drug, Onpattro, reached the market, followed by the approval of Givlaari in 2019, and many other clinical trials are in progress.

Holding the potential to treat a wide range of diseases from cancer to immunological disorders, siRNA therapeutics have received plenty of attention. With the support of a suitable delivery system, they can be directed to downregulate a specific target gene. Both approved siRNA drugs Onpattro and Givlaari are only able to reach the liver, however. Other organs that can be treated by loco-regional administration, such as the lung, are, in principle, good targets for siRNA therapies as well.

In this view, siRNA-baseddrugs could not only act as an ally in the battle against the current COVID-19pandemic but also against other severe lung diseases such as asthma. Despitethe great advances in asthma treatment, this disease still represents an unmetmedical need in about 510% of patients.Moreover, most of the available drugs work symptomatically rather than causally.

In a recent article published in WIREs Nanomedicine and Nanobiotechnology, Domizia Baldassi and Tobias Keil, graduate students in Prof. Olivia Merkels research group at the University of Munich, discuss the groups advances towards developing a nanocarrier that can deliver siRNA into T cells in the lung.

The aim of T-cell delivery is downregulation of GATA-3, the transcription factor of T helper 2 (TH2) cells overexpressed in asthmatic patients, which is recognized as a key factor in the asthmatic inflammatory cascade. Based on their observation that transferrin receptor is overexpressed in activated T cells, the researchers sought to find a virus-like tool to target activated TH2 cells specifically and efficiently in a receptor-mediated manner.

They accomplishedthis goal by creating a conjugate formed by transferrin and low-molecular-weightpolyethylenimine (Tf-PEI). On the one hand, they used a well-known cationic polymerto electrostatically interact with the negatively charged siRNA and protect itfrom degradation during the journey through the airways. And on the other hand,transferrin served as a targeting moiety to mediate a specific, targeteddelivery of siRNA only to activated T cells.

Since theendosomal escape is considered the rate-limiting step in cytoplasmaticdelivery of nanoparticle-based therapies, improving this aspect of theformulation was the focus, and Tf-PEI was blended with a second conjugatecomposed of melittin and PEI (Mel-PEI). Melittin is a well-known membranolyticagent from bee venom that was chemically modified to react in a pH-dependentmanner.

The researchersexploited the intrinsic lytic characteristic of the peptide to improve therelease of siRNA into the cytosol, reaching knockdown levels as high as 70% exvivo. But further steps such as the validation of these results in vivo on anasthma mouse model are needed, as well as possible alternative polymericmaterials.

In the process of developing a new pharmaceutical product, it is crucial to keep the administration route in mind. Spray drying is the most straightforward technique to produce inhalable particles for pulmonary delivery, according to the researchers. In a proof-of-concept study, they obtained nano-in-microparticles by spray drying PEI-pDNA polyplexes together with a cryoprotectant agent. After seeing promising results, their studies to obtain a dry powder formulation of siRNA-based polyplexes are ongoing.

Ultimately, both research fields will be combined and hopefully result in a new therapy for the treatment of severe, uncontrolled asthma and many other lung diseases, concluded Baldassi, Keil, and Merkel.

Reference: Tobias W. M. Keil et al. T-cell targeted pulmonary siRNA delivery for the treatment of asthma. WIREs Nanomedicine and Nanobiotechnology (2020). DOI: 10.1002/10.1002/wnan.1634

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Biotechnology A new, inhaled siRNA therapeutic option for asthma - Advanced Science News

Recommendation and review posted by Bethany Smith

The Gene Therapy market demand is anticipated to flourish during the forecast period 2020-2027. The report offers information related to import and export, along with the current business chain in the market at the global level. This report provides an in-depth overview of the Gene Therapy market. This includes market characteristics, consisting of segmentation, market share, trends and strategies for this market. The Market Size section provides historical forecasts of market growth and future. An in-depth analysis of the major companies operating in the market is also mentioned in this research report.

The global Gene Therapy market is segmented on the basis of type and application. It also provides market size and forecast estimates from the year 2020 to 2027 with respect to five major regions, namely; North America, Europe, Asia-Pacific (APAC), Middle East & Africa (MEA), and South America (SAM). The Gene Therapy market by each region is later sub-segmented by respective countries and segments. The report covers the analysis and forecast of top countries globally along with the current trend and opportunities prevailing in the region.

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A thorough examination of the Gene Therapy market includes each and every aspect, which begins with knowing the market, speaking with clients, and evaluating the complete data of the global market. For more clarification, the global market is segmented on the basis of the manufacture of the kind of products, and their applications. The report also delivers information as per the regions based on the geographical classification of the global Gene Therapy market. The dynamic foundation of the global market is based on the calculation of product supply in different markets, their revenues, capability, and a chain of production.

Qualitative information will discuss the key factors driving the restraining the growth of the market, and the possible growth opportunities of the market, regulatory scenario, value chain & supply chain analysis, export & import analysis, attractive investment proposition, and Porters 5 Forces analysis among others will be a part of qualitative information.

Furthermore, this study will help our clients solve the following issues:

All in all, the Gene Therapy market research study elucidates a detailed evaluation of this business and projects this industry to register a commendable growth rate in the forthcoming years. The Gene Therapy market analysis report also delivers important insights with respect to aspects such as the volume of sales, valuation forecast, market size, and the market competition trends as well as the market concentration rate.

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Have a look on Key Questions Answered in this Report:

Finally, this business guide will be helpful for both established and new players to sustain in the competitive Gene Therapy market world as it mentions the key geographies, market landscapes alongside the product price, revenue, volume, production, supply, demand, and market growth rate & gives the maximum possible profit for your company.

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Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.

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Gene Therapy Market 2020 Overview | Identify Opportunities and Challenges | Size, Share and Industry Analysis by coherentmarketinsights.com -...

Recommendation and review posted by Bethany Smith

The partnership will help accelerate the time-to-market of the Jeeva decentralized clinical trial solution.

WASHINGTON (PRWEB) April 08, 2020

KiwiTech, LLC, an innovation platform that helps startups build viable products, drive traction, and raise capital, today announced a strategic partnership with Jeeva Informatics Solutions Inc, an AI-driven startup that builds patient-focused big data and digital health solutions for accelerating clinical research.

"We are excited to support Jeeva in their mission to decentralize clinical research, reduce patients' travel burden and optimize operations," said Rakesh Gupta, Co-Founder, and CEO of KiwiTech. "Though Jeeva set out on their vision much before the current pandemic, it has become particularly relevant in the context of COVID-19. We look forward to helping Jeeva further its mission and scale through our unique startup ecosystem."

While Biopharmaceutical companies have been conducting randomized controlled clinical trials for over 70 years, the traditional process has become unsustainable. According to a 2018 report by PhRMA, the average cost of bringing one successful therapy to market through FDA approval exceeded $2.5B and took over 12 years.

Jeeva Informatics was selected by the National Science Foundation (NSF) in Spring 2019 into the Innovation Corps grant program at their Massachusetts Institute of Technology (MIT) node, Boston, MA to understand first-hand, the various stakeholders' perspectives on the pain-points and bottlenecks. Having interviewed over 300 customer stakeholders of clinical trials in the U.S., the major pain points recorded consistently were patient recruitment, retention, and protocol adherence.

"Patients' travel burden of visiting brick-and-mortar sites is a single problem that, when solved right, can help address all of those customer pain-points. Jeeva is focused on solving this problem by developing a real-time decentralized solution for collecting patients' outcomes data which replaces in-person interactions with videoconferencing, digital engagement, and remote safety monitoring. Such a robust solution can enable our customers to better manage unforeseen complexities, such as those arising out of a global pandemic." said Harsha Rajasimha, founder and CEO of Jeeva.

Earlier this year in January, Jeeva had announced a round of investment led by CITGapFunds and plans to launch its first product in late 2020 with several clients. Jeeva's initial focus will include long-term follow-ups after the administration of cell and gene therapies for rare diseases and Cancer. Jeeva is seeking additional early adopters and strategic partners with access to real-world clinical settings.

"Our selection process is highly competitive. In 2019, we received 40,734 startup applications, interviewed 2,501 of them, and invested in only 109 of them. Jeeva expects to achieve its minimum viable product in 2020 for its initial set of customers and strategic partners. The partnership with KiwiTech allows Jeeva to leverage our deep technical expertise and insight to realize the promise of decentralized or hybrid clinical trials in the U.S. and eventually globally," said Gupta.

About KiwiTech

Over the last decade, KiwiTech has led innovation across multiple verticals scaling businesses in the tech space. KiwiTech intimately understands the challenges faced by new founders, aspiring unicorns and established leaders and works closely with them to realize their passion and purpose. Through its extensive relationships and expertise, KiwiTech brings a perspective that helps strategically connect technology creators with technology consumers. KiwiTech is an ecosystem of proactive investors and advisors who are passionate about building technology, supporting entrepreneurship, and helping companies realize their maximum potential.

About Jeeva Informatics

Jeeva is a seed-stage venture-backed startup on a mission to develop AI-driven decentralized clinical trials and optimize patient-focused clinical research. The Jeeva Trials solution reduces patient travel burden by replacing in-person trial site visits with videoconferencing, remote monitoring and digital engagement. Jeeva is particularly beneficial for both rare disorders and clinical research studies involving long-term follow-ups and safety monitoring. Jeeva is a member of several life science membership organizations including Virginia BIO, BioHealth Capital Region, and the Global Genes Corporate Alliance.

For the original version on PRWeb visit: https://www.prweb.com/releases/kiwitech_and_jeeva_informatics_solutions_announce_strategic_partnership/prweb17039405.htm

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KiwiTech and Jeeva Informatics Solutions Announce Strategic Partnership - Benzinga

Recommendation and review posted by Bethany Smith

GLASGOW, Scotland, April 8, 2020 /PRNewswire/ -- Lamellar Biomedical Limited (Lamellar), an innovative biotechnology company pioneering new approaches to address respiratory diseases and complex lung disorders with its LAMELLASOME platform, announces the launch of a program to address the potentially fatal consequences of COVID-19 on respiratory function.

A LAMELLASOME nebulised treatment used at the early stages of COVID-19, in hospital or the community, could reduce the damaging and often fatal inflammatory response known as Acute Respiratory Distress Syndrome (ARDS) seen in patients. This early intervention has the potential to inhibit fibroproliferative changes during ARDS, markedly reducing severity, mortality and lowering the significant burden placed on the healthcare system.

The time between onset of symptoms of SARS-CoV2 infection and progression to more severe clinical manifestations of COVID-19 such as viral pneumonia and ARDS, is thought to be between 5 8 days. Inhaled LAMELLASOME treatment administered during this period has the potential to halt or reduce the severity of the disease progression of COVID-19 patients to requiring scarce critical care resource.

Lamellar has strong pre-clinical evidence of inhaled LAMELLASOME's protective nature. In a large animal invivo model of radiation-induced lung injury, designed to replicate the pathology found in the injured lung, which is representative of COVID-19 patient pathology, inhaled LAMELLASOME treatment protected lung cells and tissues from injury, pneumonitis and fibroproliferation/fibrosis at the alveolar/capillary membrane.

Dr Duncan Moore, Chairman of Lamellar, said: "In the past few weeks we have seen the terrible consequences COVID-19 can have on the respiratory function, particularly on vulnerable patient populations. We believe that that the inherent attributes of LAMELLASOME are extremely well suited to be a potential approach to preventing the onset of the serious respiratory symptoms seen in COVID-19 patients. Lamellar is focused on treating complex lung disorders and we believe that our Lamellasome formulations could make an important difference to patients and healthcare providers globally."

Dr Nik Hirani, Reader in Respiratory Medicine and Associate Medical Director in Lothian and Former chair of NICE Thoracic Interstitial Lung Disease guideline committee, said: "Lamellar has very convincing data demonstrating strong in-vivo efficacy for Lamellasome formulations in a model relevant to pneumonitis, lung injury and ARDS. I have been following the development of LAMELLASOME technology and its development as a respiratory therapeutic over the past few years, and I believe it has real potential to manage the inflammatory respiratory symptoms seen in patients infected with SARS-CoV2."

About Lamellar Biomedical

Lamellar Biomedical Limited (Lamellar), is an innovative biotechnology company, developing our proprietary LAMELLASOME based therapies to transform the treatment of complex and rare lung disorders.

Lamellar's lead products are:

In addition, LAMELLASOME technology can be designed to deliver active payloads such as gene therapies, or by utilising intrinsic anti-infective properties which can enhance antibiotics.

Founded in 2007, Lamellar is backed by both institutional and private investors, including Invesco, Scottish Enterprise, Barwell Plc, TRI Capital and has multiple research collaborations with world renowned institutions and universities.

About LAMELLASOME Technology

LAMELLASOME vesicles are synthetic lipidic mimetics of native human lamellar bodies found in lung tissue. These properties provide low immunogenicity and excellent safety, LAMELLASOME vesicles have been shown to have inherent pulmonary protective effects. LAMELLASOME therapies are based on LAMELLASOME's abilities to:

LAMELLASOME formulations have excellent preclinical safety, a very high NOAEL (taken from inhalation toxicology) and excellent clinical safety and tolerability profile.

LAMELLASOME therapeutics are synthetically formulated. As such, they do not require harvesting or human extraction, and they can be manufactured using standard, scalable industry processes and components that facilitate commercially competitive COGS. They can also be optimised to deliver active payloads such as gene therapies and anti-infectives.

Story continues

See more here:
Lamellar Biomedical Launches Program Designed to Prevent the Severe Respiratory Effects of COVID-19, Using its Unique LAMELLASOME Technology - Yahoo...

Recommendation and review posted by Bethany Smith

SAN DIEGO Apr 8, 2020 (Thomson StreetEvents) -- Edited Transcript of Organovo Holdings Inc earnings conference call or presentation Thursday, November 9, 2017 at 10:00:00pm GMT

Organovo Holdings, Inc. - CFO

* Steve E. Kunszabo

Organovo Holdings, Inc. - VP of IR & Corporate Communications

* Taylor J. Crouch

Organovo Holdings, Inc. - CEO, President & Director

* George B. Zavoico

B. Riley FBR, Inc., Research Division - Analyst

Good afternoon and welcome to the Organovo Holdings fiscal second quarter 2018 earnings conference call. (Operator Instructions.] Please note this event is being recorded. I would now like to turn the conference over to Steve Kunszabo, Head of Investor Relations. Please go ahead.

Steve E. Kunszabo, Organovo Holdings, Inc. - VP of IR & Corporate Communications [2]

Good afternoon and thanks for joining us. I'd like to welcome you to our fiscal second quarter 2018 earnings call. Joining me on the call this afternoon: our CEO, Taylor Crouch; our CFO, Craig Kussman; and our General Manager, Paul Gallant. Today's call will begin with a discussion of the 2018 fiscal second quarter results, followed by Q&A.

Before I turn things over to Taylor, I'd like to caution all participants that our call this afternoon may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts and include statements about our future expectations, plans and prospects. Such forward-looking statements are based upon our current beliefs and expectations and are subject to risks which could cause the actual results to differ from these forward-looking statements. Such risks are more fully disclosed in our filings with the Securities and Exchange Commission. Our remarks today should be considered in light of such risks. Any forward-looking statements represent our views only as of today. And while we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our expectations or views change.

During the call we'll also be referring to certain non-GAAP financial measures. These non-GAAP financial measures are not prepared in accordance with generally accepted accounting principles. Please refer to today's earnings release for a definition of these non-GAAP financial measures.

With that, let me turn things over to Taylor.

Taylor J. Crouch, Organovo Holdings, Inc. - CEO, President & Director [3]

Thanks, Steve, and good afternoon, everyone. I'll get us started by highlighting that our top line results of $1.4 million for the quarter represented our second-highest quarterly revenue to date and our third consecutive quarter of sequential revenue growth. This is good progress as we streamlined the business around maximizing the uptake of our liver and kidney tissue systems. But we still have more work to do.

We updated our full-year revenue and negative adjusted EBITDA guidance today, which reflects the latest assessment of our growth trajectory. We are prioritizing disease modeling capabilities as we head into the second half of our fiscal year and de-emphasizing our work in the routine toxicology research area. Our guidance also shows the benefit of cash burn from our organizational restructuring. Craig will provide more detail on our financials and the revised elements of our outlook in his remarks.

As I consider the steps we've taken in the last few months to recalibrate our direction and evaluate the best path forward, our strategic identity has come into clearer focus. Our highly customizable 3D tissue platform affords us the ability to monetize our capabilities in many ways. We provision and curate primary human cells for use in research applications through our Samsara business. We've created dynamic disease models that can facilitate drug discovery and profiling in ways never thought possible. We've struck licensing agreements that capitalize on our proprietary technology and intellectual property, and we continue to develop our own novel therapeutic tissue products to address critical unmet disease areas. We are working across a broad value chain that spans the drug discovery and development ecosystem with what we believe are the industry's leading liver and kidney tissue systems.

Moving now to our commercial tissue business where our bioprinted liver remains the primary engine of growth, I'd like to share a few leading indicators underscoring the strength of new business, the health of our revenue mix, the growing value of our services and our significantly reduced cycle times.

First, we added 8 customer accounts in the first half of fiscal 2018 including 3 clients projects with products already in clinical trials and we continue to see momentum in bring new business aboard.

Second, we continued to see a healthy revenue mix during the first 6 months of our fiscal year, with a 60% to 40% split between repeat business and new orders. This is consistent with our breakdown in fiscal 2017 and supports the ongoing move by our clients up the adoption curve.

Third, we've driven our average revenue per order higher over the last 2 quarters, largely as the result of shifting our work to compound screening and disease models. In the first half of fiscal 2018, approximately 65% of our orders represented disease modeling projects. This is good news because our competitive differentiation is particularly strong in these applications including target identification, marker validation and lead optimization.

Lastly, our cycle time from sending out a customer proposal to closing an order has declined sharply. In late 2016 we were averaging over 7 months for this important business development metric. In the first half of fiscal 2018, we've brought the span down to under 2 months, in part owing to the master services agreements and repeat business we have with our existing customers as well as to better understanding our client needs relating to projects outlined and study design. In addition, as a result of our business development, marketing and scientific outreach, many new and existing clients are seeking out our services with a sense of urgency to interrogate their drugs on our platform.

Our progress in studying liver disease has also been bolstered by the $1.7 million grant award we received from the NIH to collaborate with UC San Diego to evaluate NASH in our 3D bioprinted liver model. I also note our collaboration with Viscient Biosciences to develop a custom research platform that targets early discovery work for liver disease. We're also pleased with the distinction and reception our posters received at the recent American Association for the Study of Liver Disease annual meeting, which is one of the most influential conferences in the liver disease space.

Overall, our shift to disease modeling services recognizes the important role that liver disease plays in pharmaceutical R&D while also representing the highest-value opportunity for our commercial business. We're seeing deeper engagement from our clients in this space as we discuss annual budget allocations and framework agreements for our services. Ultimately, these are important steps as our customers move from single-project commitments to dedicated research plans and meaningful annual revenue commitments.

Let's turn now to a quick progress update on our therapeutic tissues business. As many of you saw in our recent announcement, we achieved major scientific milestones for the extended survival and functionality of our liver therapeutic tissue and we remain on track to submit our first investigational new drug application to the FDA during calendar year 2020. Our bioprinted liver tissues showed significant engraftment, retention and functionality through 125 days post-implementation in well-established animal models for one of the inborn areas of metabolism, namely alpha-one-antitrypsin deficiency. Importantly, thorough evaluation of the treated animals suggests an approximately 75% reduction in the pathologic hallmarks of disease in treated areas. In short, our liver patch meaningfully cleared the disease in the immediate area of the implant.

The data show that the approach of delivering a 3D bioprinted tissue patch directly to the liver offers great promise in solving the retention and integration issues that have held back many cell and gene therapy attempts at treating these debilitating pediatric liver diseases. These are also major achievements because we believe they align with the historical expectations of regulators for these types of preclinical studies and allow us to confidently move on to the next phases of our development work now that these elements have been completed.

Regarding next steps, we'll continue to move forward with our application to seek orphan drug designation in the next several months, and we've now begun new animal model studies in a second therapeutic indication within the category of inborn areas of metabolism.

In closing, we've taken concrete steps in the first half of the fiscal year to sharpen our focus on liver and kidney tissue systems, we've shifted our commercial priorities to be centered on higher-demand and higher-value disease modeling projects and we've restructured the organization to support these objectives. In doing so, we've improved our future revenue growth trajectory while also reducing our operating costs and materially lowering our cash burn rate. My emphasis will continue to be on meeting with customers, driving adoption of our platform commercialization, finalizing key proof-of-concept work for our liver therapeutic tissue program and translating all of this progress into value inflection points. And we will continue to be good stewards of our balance sheet. I look forward to communicating with you again soon as we execute against these important commercial and research milestones.

With that, I'll turn it over to Craig for a more complete financial review.

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Craig Kussman, Organovo Holdings, Inc. - CFO [4]

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Thanks, Taylor, and good afternoon, everyone. I'll begin by recapping our key financial metrics for the fiscal second quarter and then summarize the fiscal 2018 guidance we updated today. I'll wrap up my thoughts by briefly reviewing our balance sheet and liquidity profile.

Organovo generated fiscal second quarter total revenue of $1.4 million, which was down 2% from the prior-year period and up 37% sequentially. Total revenue results were driven by lower collaborations revenue, as key collaboration agreements were completed in the prior fiscal year, partially offset by grant payments related to our recently awarded NIH grant. Product and service revenue was $0.9 million, down 8% from the prior-year period. As Taylor noted, we're recalibrating our business development effort to focus on higher-demand and higher-value disease modeling services. Although we saw a significant increase in disease modeling orders, which were approximately 65% of total orders in the second quarter, these gains were not enough to offset the toxicology research services revenue we recorded in the year-ago quarter. Despite the short-term impact as we now deploy our resources against this new market opportunity, we see robust uptake of compound screening and disease models and expect it to be a major revenue growth component going forward.

I'll focus next on operating expenses. We reported $0.3 million in cost of revenues for the fiscal second quarter, a 35% decline from the prior-year period. The drop in cost of revenues was largely due to a greater contribution from higher-margin primary human cell and tissue products. Research and development expenses were $4.9 million, a 9% year-over-year increase, primarily resulting from higher facilities and employee-related costs. We recorded $5.7 million in selling, general and administrative expenses during the fiscal second quarter, a 3% year-over-year decrease, largely due to lower external professional services fees and facilities costs. SG&A also included approximately $0.4 million of one-time CEO transition and employee severance costs. As we look ahead to the fiscal third quarter, it's worth emphasizing that we'll record an approximately $0.9 nonrecurring charge related to our recently announced organizational restructuring.

And finally, a brief review of the full year fiscal 2018 outlook we updated today and a few quick notes on our balance sheet and liquidity profile. We now forecast total revenue between $4.5 million and $6.5 million for fiscal year 2018, with the primary contributions coming from a few key components: continued strong growth of our disease modeling services, recording the balance of our deferred revenues from the previous year, accelerating growth from our primary human cell and tissue products and accelerating progress on our NIH grant, of which $200,000 to $600,000 is reflected in our fiscal 2018 guidance range.

While we've revised our fiscal 2018 outlook and now expect a delay in ramping to a double-digit annual revenue rate, we remain confident that one or more of our customers will move from single-project commitments to annual revenue commitments over the course of the next few quarters. Achieving this goal with our customers should position us to meet this important revenue metric in 2019.

On the same basis for the full year fiscal 2018, we now expect negative adjusted EBITDA between $26 million and $28 million. This is an improvement in our cash burn from our previous estimate and is largely driven by the reduced operating costs we'll benefit from as the result of our organizational restructuring and a streamlined focus on our existing commercial opportunities and therapeutic tissue program. By comparison, we recorded $29.8 million of negative adjusted EBITDA for fiscal 2017.

Before I move on to our balance sheet, a few quick words on the evolution of our Samsara subsidiary and its growing contribution to our business. First, it provides us with great expertise in the sophisticated isolation and curation of our target liver cells. Second, we're able to further explore how disease origin cells perform in our tissue models across various disease states. Finally, it benefits us from a business development perspective, as many clients who worked with Samsara first moved to also engage in more complex liver and kidney disease services. All in all, great synergies between the 2 operations as Samsara becomes a more meaningful portion of our total revenue.

Now for our balance sheet. At the end of the fiscal second quarter, we had a cash and cash equivalents balance of $50.7 million and we have approximately $17 million of funds available under our ATM facility. In combination, this gives us approximately $68 million in available liquidity to carry out our business plan and invest in our key growth initiatives. As circumstances and market dynamics permit, we'll continue to use our ATM facility opportunistically to extend the cash runway for the business, allowing us to scale our liver and kidney tissue research services and moving our promising liver therapeutic tissue closer to human clinical trials. The ATM facility is a flexible tool that lets us strengthen our balance sheet in a disciplined way while moving us forward to key value inflection points as we consider our long-term capital plan. If we're able to successfully execute against our planned ATM strategy, we do not currently envision a traditional equity raise such as a follow-on equity offering for the remainder of fiscal 2018.

I'll wrap up by noting that we believe there's a growing value for Organovo as we continue to advance our liver therapeutic issue and achieve major scientific milestones. As for our commercial business, we continue to streamline our operations and redeploy our effort against the best opportunities to grow our revenue in the liver and kidney space. Disease modeling represents a big part of this future path. We look forward to updating you on our progress in February.

With that, I'll turn things back over to the operator for the Q&A portion of this afternoon's call.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And our first question comes from Brandon Couillard with Jefferies.

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Christian Peter Trigani, Jefferies LLC, Research Division - Former Equity Associate [2]

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This is Christian on for Brandon. First off, I understand you're taking a broader shift into disease modeling, but it would be helpful if you could provide additional commentary in terms of the key variables that drove the materially lower full year revenue outlook. I'm just trying to understand, given the magnitude of the downward revision, why you didn't ultimately decide to prerelease the development or update the full year view concurrent with the restructuring plan announced in early October.

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Taylor J. Crouch, Organovo Holdings, Inc. - CEO, President & Director [3]

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This is Taylor. And one of the challenges that we face, and that's why we've given a broad revenue guidance, even for this remaining several months of our fiscal year, is that we have a number of binary events that we hope and plan and are working toward breaking our way, which could result in significantly more revenues. But as each month closes, we have to recognize the risk that some of these binary events don't go our way in this fiscal year but move into the final -- into the next fiscal year.

As an example, we've mentioned that our deferred revenues for clients that we have hoped, and certainly still plan to try and achieve this year, may or may not fall into this fiscal year. And similarly, you see with our NIH grant revenue a significant range tied to certain operational risk variables and NIH grant approval processes that affect this range. So it's more an issue of being more cautious about the outcomes as we see -- as we evaluate these binary events, as well as reflecting that we truly had hoped to see some more traditional routine tox business from our earliest clients. But now we realize that the investments we would have to make to convince them to move over their thresholds to incorporating us into what ultimately is a lower-margin but higher-volume business, those thresholds don't provide us the same return on investment as we're seeing by investing now heavily in our disease modeling platforms, which are being driven by significant and enthusiastic demand from those clients. So it's a number of forces that are coming together, and our visibility on these forces clarifies as we approach the end of the year. And we just thought it was more prudent to wait until this call to clarify that situation.

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Christian Peter Trigani, Jefferies LLC, Research Division - Former Equity Associate [4]

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Okay, understood. That's very helpful. And then I guess, also probably for Taylor, maybe a 2-part question. I would be very interested to hear an update on how the conversations are progressing in terms of moving the target one or more clients for a larger multiyear routine use engagement. To be clear, do you still expect that to occur within the fiscal year '18? And maybe help us quantify how many customers might be in that Phase 2 bucket currently that could over time move to steady-state use over maybe the next 12 to 18 months.

And then secondly, do you think you have enough current capacity to perhaps inboard those customers over time? And if so, maybe give us a rough percentage of what capacity you think you would need to commit to such customers to fulfill a larger engagement.

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Taylor J. Crouch, Organovo Holdings, Inc. - CEO, President & Director [5]

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Okay, thanks. Both great questions. With regard to our clients moving along the adoption curve, and so the Phase 2 that you referred to, for the others on the call, represents the final validation of our custom research platforms, a process that we're undergoing for each of our clients. And in some cases, by the way, we're validating more than one platform. And the final step of that phase is to begin running standard reference compounds through our platforms to show how they modulate the very diseases that we've created in our tissues in these unique platforms. And I am pleased to say that we now have a handful of clients that are in this final step of the -- of testing the modulation strategies with either reference or, in some cases, with proprietary compounds. As son as that's completed, we believe the very next step is to move to more routine use for proprietary screening and profiling larger numbers of compounds. And we do indeed have conversations underway at more than one client along those lines, and that continues to give us confidence that we will exit this fiscal year tracking toward that routine use, more annual perspective kind of collaboration agreement.

Your second question as regards to capacity, we actually have significant capacity here to expand, certainly to meet the needs both for our commercial tissue business as well as our therapeutic tissue research program to handle various growth scenarios over the next couple of years. So we don't worry about capacity, and we have scalable, modular capacity built around our printing platforms that can easily be scaled up when and if necessary.

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Christian Peter Trigani, Jefferies LLC, Research Division - Former Equity Associate [6]

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Great. And then maybe if I can sneak one more in. Recently we noticed another 3D tissue player in the landscape signed a deal with the CRO, Charles River. Now I understand this player has a somewhat different focus and value proposition, but would be curious to know at a high level if you see an opportunity over time to potentially work more closely with other CROs out there, and if so, possibly over what time frame that could occur. Thank you.

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Taylor J. Crouch, Organovo Holdings, Inc. - CEO, President & Director [7]

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Actually, I'll grab that question as well. As you may know, my background, a big part of my career has been spent in the CRO industry and the biotech positions I've held in those positions, I've also been instrumental in putting strategic CRO collaborations in place with all of the leading CROs. And certainly, we see an opportunity as we scale and as we establish more repetitive use applications on our platform to work with CROs, certainly if we approach a capacity constraint. And so I think it would be very reasonable to expect us to be working, collaborating and announcing appropriate agreements in the fiscal year to come along those lines.

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Operator [8]

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Our next question is from George Zavoico with B. Riley-FBR.

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George B. Zavoico, B. Riley FBR, Inc., Research Division - Analyst [9]

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I have a question about your therapeutic tissues, your liver tissues. Your shift in focus -- part of it is perhaps a disappointing potential revenue stream from the toxicology research services, but it must be balanced by some sort of marketing surveys that you may have done with the therapeutic tissues despite the fact that you're waiting for an IND until 2020. So the question is what kind of supportive marketing information do you have that really speaks to the potential demand and the potential revenue stream from this, and are you looking for partnering opportunities as well in this regard, in this sector?

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Taylor J. Crouch, Organovo Holdings, Inc. - CEO, President & Director [10]

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So first, in terms of demand, we mentioned some of our cycle time statistics. And a year ago, the process of getting a meeting with a classic toxicology decision maker to discuss how our experimental but promising platform might be useful, there was interest, but I wouldn't call it overly enthusiastic, and often it took months and months to close a first revenue opportunity with those decision-makers.

On the disease modeling side, our partners are therapeutic teams, clinicians that actually have real problems they need to solve with a high degree of urgency, and/or people in discovery who so far have had no other in vitro solutions to explore how their drugs will perform in human-like settings in these disease models. So we actually have a significant amount of people -- clients -- reaching out to us. We have clients that we've talked to in the past about toxicology coming much more enthusiastically to discuss our disease models, and I'd say we have a veritable Who's Who of people working in the NAFLD, NSH and fibrosis space across U.S., Europe and Japan beginning to move forward with us along this adoption phase. So it's really a demand-driven opportunity. We see the market opportunity is quite significant because the later you get in discovery, as you know, with research services, the more the value of the drugs you're touching has. And so as you move forward to lead optimization, preclinical candidates and certainly drugs that are always in the clinic, we are creating and enabling a much higher-value outcome for our clients in their decision-making. And we're seeing an uptick in the revenues and the sense of urgency that they have to work with us. And all of these things have built toward the decision to move in this space, as well as recognizing that we, as liver experts, already are developing our own therapeutic solutions with our tissues in and around the liver space. And this gives us tremendous credibility with sophisticated clients focusing liver disease or better understanding their drug in the liver and kidney environment.

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George B. Zavoico, B. Riley FBR, Inc., Research Division - Analyst [11]

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So the disease modeling aspect, which is the services part of your therapeutic tissue sector, that's the part you see, say, perhaps revenue per unit or revenue per client is substantially greater than the toxicology services, and that could drive your own research into developing your own therapeutic tissue for which you expect an INDD in 202? So that's sort of the balance? Is that -- am I understanding that correctly?

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Taylor J. Crouch, Organovo Holdings, Inc. - CEO, President & Director [12]

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I think that's a good way to look at it. And clearly, we're still in an early revenue-generation mode. I see a logical and attractive opportunity to build our revenues along the lines that you just described. We also have mentioned in our comments many of the other ways that complement our platform in terms of how we can monetize our capabilities, starting with our very sophisticated ability to isolate and curate cells, which we do for ourselves, but is also a growing demand out in the marketplace, all the way through to licensing of our technologies for people who would like to bring some of these capabilities in-house. But certainly in the field of NASH, fibrosis and other liver disease areas that we're being asked to begin looking at, we see an overlapping layer by layer of model -- of platform development clients, revenues associated with that, and then the product screening and profiling revenues that come with each of those overlapping platforms that we develop. So it's a nice, healthy business model.

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George B. Zavoico, B. Riley FBR, Inc., Research Division - Analyst [13]

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Continued here:
Edited Transcript of ONVO earnings conference call or presentation 9-Nov-17 10:00pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

APRIL 07, 2020 --Endocrinologists have underlined the importance that physicians consider "a stress dose" of glucocorticoids in the event of severe COVID-19 infection in endocrine, and other, patients on long-term steroids.

People taking corticosteroids on a routine basis for a variety of underlying inflammatory conditions, such as asthma, allergies, and arthritis, are at elevated risk of being infected with, and adversely affected by, COVID-19.

This also applies to a rarer group of patients with adrenal insufficiency and uncontrolled Cushing syndrome, as well as secondary adrenal insufficiency occurring in hypopituitarism, who also rely on glucocorticoids for day-to-day living.

As such, it is vitally important to recognize that "Injectable supplemental glucocorticoid therapy in this setting can reverse the risk of potentially fatal adrenal failure and should be considered in every case," Stewart and colleagues emphasize in a newly published editorial in JCEM.

They note this advice must be considered alongside World Health Organization (WHO) guidance against prescribing therapeutic glucocorticoids to treat complications of COVID-19, based on prior experience in patients with acute respiratory distress syndrome, as well as those affected by severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

The key difference here is not to use pharmacologic doses of glucocorticoids as treatment for COVID-19 (where they have no effect), but rather to prevent death from adrenal failure by using "stress" doses of replacement glucocorticoid, Stewart explained to Medscape Medical News.

"The intent here is to ensure that no patient with a history of prior exposure to chronic glucocorticoid therapy (> 3 months) by whatever route should die without consideration for parenteral glucocorticoid therapy," the editorialists write.

He advises using physiological stress doses of hydrocortisone (50-100 mg intravenously tid).

Specific Advice for Adrenal Insufficiency: Follow Sick Day Rules

A separate statement by the American Association of Clinical Endocrinologists (AACE) also emphasizes that it is particularly important for patients with adrenal insufficiency to follow advice from the Centers for Disease Control and Prevention (CDC) or similar guidance on preventing COVID-19 infection, including social distancing and frequent hand washing.

Such patients should continue to take medications as prescribed and ensure they have appropriate supplies of oral and injectable steroids, ideally for 90 days, AACE advises.

And if there is a shortage of hydrocortisone, the statement advises patients ask a pharmacist or physician about replacement hydrocortisone with different doses that might be available.

Stewart agrees that patients with adrenal insufficiency need to be hypervigilant, but says that "if they do become ill, for the most part they are well counseled to respond appropriately to intercurrent infections."

Nevertheless, it is "invaluable to reiterate 'sick day rules'" for suspected COVID-19 infection.

"Any patient who develops a dry continuous cough and fever should immediately double their daily oral glucocorticoid dose and continue on this regimen until the fever has subsided."

If a patient still deteriorates on this regimen, develops diarrhea or vomiting, or is unable to take oral glucocorticoids for other reasons, they should contact their physicians or seek urgent medical care to receive parenteral treatment with a glucocorticoid.

References

2020 WebMD, LLC. All Rights Reserved.

View original post here:
Corticosteroids With COVID-19 in Asthma, Allergies, and Arthritis Patients - MedicineNet

Recommendation and review posted by Bethany Smith

Children with life-limiting illnesses have been receiving parcels of joy to help put smiles on their faces during the coronavirus lockdown, thanks to the Sunflowers Children's Action Group.

Joanne Wright set up the charity in July last year after spotting a gap in the provision of support across the northern Lincolnshire area for children with life limiting illnesses or life threatening conditions.

The handful of unpaid volunteers who work with Joanne, simply wanted to make a difference in the community and the gift parcels have been the charity's way of putting a smile on a child's face during the ockdown.

Joanne said: "Even before the national lockdown, many parents were advised to keep their children at home because of their childrens vulnerability owing to medical problems.

"I was talking to one parent and so wanted to do a little something to show we cared and would help to give a poorly child a surprise.

"We realised that it would be some time before we could do a group event, so the closest thing we could get to that was to do this."

Items in the parcels include sweets and chocolate left over from a Santa's sweet stall - all individually wrapped, still in date and properly stored - along with bags of mini eggs Deebees had previously donated and previously received toys and books.

Each parcel is carefully tailored to the age of the recipient, which currently ranges from three to 16.

Sunflowers has sent out around 60 of these cheery parcels and Joanne said the feedback she has received had been wonderful.

She said: "The children have been thrilled, judging by the reactions that have been posted on our Facebook page.

"I think it really means something to the parents too, that people out there are thinking of them.

"What we have to remember is that although isolation and the current situation brings us all problems. These are families who are largely isolated, struggling and battling to try and keep their children healthy every day of their lives."

Among those to benefit from the initiative is nine-year-old Ethan Meadows, from Keadby, near Scunthorpe.

He has a range of conditions including septo optic dysplasia,diabetes insipidus, pan hypopituitarism and microphaly. He is gastrostomy-fed, registered blind, is non-mobile and non verbal.

His mum Tina said: "Ethan is blind so we opened the box for him, he was really happy with it. It was a lovely thing to send.

"It's nice to know you've got that support - everything is up in the air.

"It's trying to keep the kids entertained as we are out of routine."

Six year old Nathaniel Hodges from Market Rasen, who has Type I diabetes, gave a huge thumbs up to his parcel.

His mum Caroline Hodges said: "He was absolutely over the moon. We didn't tell him, it was a surprise when it came.

"It made his day because we are stuck inside. He liked the car, he wants to build it and said, 'I love it, I can't believe it!'

"They are like angels, they're so thoughtful. We're not in a normal routine so it's tough on him.

"It just brings a bit of sunshine into his day - they're an amazing group.

"We tell him how proud we are but for someone to send something through the post, it's really special. We are very grateful."

Ava Eastwood-Morgan, 4, from Grimsby has AVSD (Atrioventricular Septal Defect) and leaking heart valves, which she had successful open heart surgery for in January 2017.

The people of northern Lincolnshire have been warming hearts with their selfless gestures.

They say challenging times often bring out the best in people and thats what were seeing here inGrimsby,CleethorpesandScunthorpe.

We want to celebrate anybody and everybody who is helping others through the coronavirus outbreak and have set up a special area dedicated to them on our website.

This includes but is not limited to our heroes in the NHS, policing teams, supermarket workers, delivery drivers and cleaners.

Not to forget our wonderful community members who have been helping others out in any way they can! Its a huge thank you to you ALL.

So, click here to view our live blog and if you have something you want to share email paige.freshwater@reachplc.com

However her last heart check up revealed the valve leakage had worsened.

Mum Lottie Eastwood said: "Ava's reaction was absolutely priceless, she was so, so delighted!

"Her face lit up, she was all excitable, giggly and absolutely smitten with her gifts. She received books, teddys, sweeties, a doll and a magnetic drawing board.

" I think the gift parcel idea is brilliant. Families that are going through tough times, or children that have been through lengthy procedures or are awaiting to receive treatment deserve to feel special.

"To know that somebody is thinking about them, taking time out of their day to make sure children receive gift packages is so uplifting.

"One simple act of kindness goes a very long way and I think its important that we all look after each other through the hard times, so a big thank you to all the lovely volunteers at Sunflowers Childrens Action Group for your time and generosity."

For more top stories, breaking news and sport see GrimsbyLive

Email the reporter who wrote this story

Follow GrimsbyLive on Facebook - Like our Facebook page to get the latest news in your feed and join in the lively discussions in the comments.

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Follow us on Instagram - On the GrimsbyLive Instagram page we like to feature great pictures from our area - and if you tag us in your posts, we could repost your picture on our page!

To help Joanne and her team continue their work throughout the year and beyond the pandemic, donations can be made via http://www.justgiving.com/sunflowers-cag

Joanne added: "I think with the current situation we cant set anything in stone, so we are just trying to support our families in our own little way in the meantime."

To get in touch with the registered charity, email hello@sunflowers.org.uk or phone 07597 988809. Alternatively, see http://www.sunflowers.charity or follow @sunflowerslocal on Twitter or Facebook.

View post:
How the Sunflowers Children's Action Group has brought joy to poorly youngsters in lockdown - Grimsby Live

Recommendation and review posted by Bethany Smith

Men and women who undergo treatment for cancer react differently to radiotherapy (RT), according to evidence drawn from a literature review.

The study found a small but significant difference in response to RT.

Women generally derive a greater survival benefit and are more likely than men to be cured, but the side effects that they suffer are more severe, say the authors.

However, a radiation oncologist who was approached for comment cautioned that the literature review was selective and that more data from larger studies are needed before claims of a differences between sexes in their response to radiotherapy can be considered "definitive."

The new article, published in Critical Reviews in Oncology/Hematology, highlights the importance of including gender as a variable in clinical trials, say the authors.

"It is clear that gender plays a role in the occurrence and response to therapy of many diseases," coauthor Eva Bezak, PhD, professor of medical radiation and director of translational cancer research, University of South Australia, Adelaide, told Medscape Medical News.

"Gender should definitely be considered in this era of individualized medicine," Bezak said.

"We need to take into account the biological differences between males and females and how these differences can affect responses to treatment and even the propensity to develop certain cancers," she said.

"For example, it is already well established that men are more susceptible to head, neck, and blood cancers and women are more prone to autoimmune diseases as well as osteoporosis. In addition, scientists know that individual responses to radiotherapy are up to 80% determined by genetics," Bezak said.

The differences in responses to radiation are evident from two important historical events, Bezak noted: the Chernobyl nuclear reactordisaster in 1986, and the atomic bombing of Hiroshima and Nagasaki in 1945.

After Chernobyl, women were at increased risk for endocrine imbalance, thyroid cancer, and brain tumors, and the male-to-female birth ratio was slightly increased, probably because, as an effect of low-dose radiation, fewer girls were born to irradiated men, she said.

After Hiroshima and Nagasaki, the risk for solid cancers increased by 35% for men and by 58% for women. "This shows us that there is great cause to suspect a significant difference in the effect of radiation between genders," Bezak said.

For the current review, Bezak and her coauthors assessed eight articles on the in vitro and in vivo response to RT, and they categorized the results by gender.

In a preclinical study that involved a rodent model of pediatric RT, cognitive impairment, as measured by novel odor recognition after cranial irradiation, occurred in male mice, but female mice showed cognitive impairment only during certain stages of the estrous cycle.

In another preclinical study that focused on differences in acute lung toxicity between genders, 60% of irradiated male rats developed pneumonitis, compared with 50% of irradiated female rats. Similarly, 80% of irradiated male rats developed vasculitis, compared with 70% of female rats.

Studies conducted in patients with rectal and esophageal cancers also highlight differences in response between men and women, Bezak said.

An in vitro study that investigated gender differences of colonic motility after chemotherapy and RT for rectal cancer showed that colonic samples from males demonstrated a higher sensitivity and greater response to carbachol and histamine stimulation than did samples from females.

And a retrospective cohort study of cardiotoxicity during RT for esophageal cancer showed that women developed cardiac toxicity earlier and at much lower doses than did men.

Other studies show that women have an advantage when it comes to survival, Bezak said.

One study that assessed the impact of gender on progression-free survival (PFS) and overall survival (OS) after RT for esophageal squamous cell carcinoma found that for males, the median PFS was 10.6 months and OS was 15.9 months, whereas for females, the median PFS was 14 months and OS was 20.8 months (P = .0005).

"The increased survival here may be due to the heightened radiosensitivity in women, leading to a greater therapeutic effect," Bezak said.

Many factors could affect a person's response to radiotherapy, said Bezak.

"Obviously, there are differing anatomic and body shapes, lipid distribution, among men and women. There are lifestyle differences, because it is known that males are more likely to drink alcohol and smoke more than women. Then looking internally, we have different hormones and enzymes which dictate how we will respond to radiotherapy. We know that estrogen has some protective effect, especially when it comes to head and neck irradiation. Males can lose their sense of smell, but women don't. We speculate, because we don't have enough evidence as yet, that this could be a protective effect of estrogen," she said.

"Ideally, if we want to improve therapies, we should be developing more gender-specific treatment options," she said.

Gender is often not considered to be an independent prognostic factor, but it should be, Bezak said.

"Gender is often not isolated when people do various multivariate analyses, but researchers should start looking a bit more at gender as one of the factors. When we do preclinical research and are using cell lines, we should make sure we are using cell lines that are derived both from males and females. When we are doing animal studies, we should be using male and female animals," she said.

"I am researching head and neck cancer and also pancreatic cancer. In some of my past studies, I admit that we used female mice only, because they were less likely to bite you. At the moment, I am doing research on head and neck cancer, and unfortunately most of our cell lines are from males, so I need to record that as a potential bias. But in my pancreatic cancer research, I have made sure that 50% of the cell lines have been derived from males and 50% from females, so that will mitigate bias," Bezak said.

Approached for comment, Brian Marples, PhD, professor of radiation oncology at the University of Rochester Medical Center, New York, said this is "a nice review of selective literature."

This article "poses a question, but the answer to this question is unknown," he cautioned.

"This manuscript does not answer that question either but highlights that much more work in this area is needed," Marples told Medscape Medical News.

Marples, who is also vice chair of the American Society of Radiation Oncology'sScience Council, said the article is selective in nature.

"It does not describe negative studies, for example, and focuses instead on eight studies that show differences, and most of these are too small for firm or definitive conclusions. For example, the research on atomic bomb survivors showed more female than male cancers, but these were largely breast cancers, and data support induction of radiation-induced breast cancers, so this observation is somewhat expected," Marples said.

He agrees that gender plays a role in diseases generally and that the health of males is generally worse than females for a number of reasons, including weight, smoking history, inactivity, and different hormonal backgrounds.

However, in terms of radiosensitivity, this difference has yet to be definitively demonstrated.

"We know sex differences exist in mice in response to radiation and radiation response for some assays, with female mice less prone to cognitive defects of cranial irradiation and also potentially lung sensitivity, but we need more data from much larger studies for these claims to be definitive," Marples said.

Bezak and Marples report no relevant financial relationships.

Crit Rev Oncol Hematol. 2020 Mar;147:102881. Abstract

For more from Medscape Oncology, follow us on Twitter: @MedscapeOnc.

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Differences in How Men and Women Respond to Radiotherapy? - Medscape

Recommendation and review posted by Bethany Smith

We all have inherited family traits eye colour, height, stature and even mannerisms which set us apart from others and remind us that we belong to a certain family group.

But while many of these attributes are welcome, there are some genetic traits were not be so keen to have namely, a gene mutation which puts us at an increased risk of developing cancer.

Niki Warner knows only too well the reality of this as not only did she lose her mother, Judit, to cancer, but she discovered they are both carriers of the faulty BRCA1 gene mutation.

Originally from Hungary, Judit was first diagnosed with breast cancer in 2005, then again in 2010 and then, unfortunately, it returned for the third time in April 2016 and this is when Niki realised that her mother was going to die.

I went into autopilot, finished my exams and spent the summer at home working in a local cafe, says the 22-year-old, who is currently doing a PhD in Health Psychology at NUIG.

My mums family came from Hungary and she went there herself to avail of different treatments. Dad and I used to get out of the house sometimes when it got too much - we went for ice-cream in Carrick-on-Shannon, with embarrassing regularity. Dad was brilliant but its a very personal and long-winded thing, and I myself havent come to grips with how I coped. It wasnt a conscious decision, but its just something you do and get on with.

Judit sadly passed away in August 2016, having also been diagnosed with the genetic mutation, and since then her daughter has been trying to pick up the pieces.

Its not been easy and I threw myself into learning what a BRCA mutation is, what being a carrier implies, and have tried to digest any bit of information I can lay my hands on, says Niki, who has a younger brother called Zoli (16) and two older half-siblings, Zac and Jess.

I remember the exact moment I found out about the mutation. Mum knew she was terminal at the time, and we were walking on a beach. I dont know if I fully comprehended what it meant and whether I grasped that I had a 50/50 chance of inheriting the genetic mutation, but she told me that I would also have to be tested.

It got put to the backburner but, after she passed away, I decided to get tested. I had an amazing GP, Dr Marion Brogan, who sorted my referral, and with Dads support I went through the process in 2017, which ended up confirming that I too carried the BRCA1 mutation.

I dont know if I was shocked, and I dont think it affected me as strongly as I retrospectively think it should have. But I guess it wasnt necessarily a bad thing, as I now have the luxury that my Mum wasnt afforded, which is to have my preventative surgeries and get ahead of the mutation.

Armed with this information, Niki is extra vigilant about her health and also about her future plans.

Im not eligible for screening in Ireland as I am too young, but when I visit my family in Hungary, I get screened there, which is good for my own assurance, she says. Its more than likely premature but I had a scare last year when they thought theyd found something in my left breast, but thankfully it amounted to nothing.

Once I get to around 30, I suppose it will be time to consider kids as Id like to have a salpingo-oophorectomy [removal of ovaries and fallopian tubes] by 35. But Im hopeful that by then, we might see newer prophylactic techniques, such as initially only removing the fallopian tubes and delaying the removal of the ovaries so I dont have to go through premature menopause, and all the issues surrounding heart, bone and brain health which go hand-in-hand with it.

However, this is still not fully researched so Im obviously holding off on that decision for now. Ill aim to have my double mastectomy, with reconstruction, around 35 as well. But for now, Im keeping myself as up-to-date as I can be with the preventative options available, and Ill make those choices when the time comes.

Nikis circumstances have also influenced her career choice, as she is now putting all her academic efforts into research to develop an online intervention to help improve coping mechanisms and knowledge following a BRCA mutation diagnosis in Ireland.

My whole career path has been funnelled into an area of research within psychology I was previously blind to, she says. I decided that the psychological care, or extreme lack of, following a BRCA mutation diagnosis was really grim, to the point where when I contacted a helpline, I was told that they didnt know what a BRCA mutation was. And then, through a cancer support centre, I was put in touch with a woman carrying a mutation who was against her children being tested as she, falsely, thought if they had a positive result it would be hard for them to get health insurance.

And while the medical team I met with were beyond kind and compassionate, there wasnt a whisper of a counselling service to be found. Its near-criminal to inform someone of their genetic predisposition to developing cancer, explain that theyll probably need to undergo both a preventative double mastectomy and salpingo-oophorectomy, and not refer them for psychological care. The ongoing implications, in relation to childbearing prospects, body image and the cancer-related distress, can be severe.

Niki says her experience was the driving force to begin her PhD, in 2018, under the supervision of Dr AnnMarie Groarke in NUI Galway and has made her a more empathetic researcher.

I will learn [through interviews] about the experiences of people diagnosed with carrying a BRCA mutation when they get the news, and Im keen to learn about what resources they found useful and what they would have liked to happen following their diagnosis. Im hoping to hear from as many people as possible, to make sure I can accurately portray this experience, and so if anyone was diagnosed with a BRCA1 or BRCA2 mutation in Ireland, Id love to hear from them. My email is n.warner1@nuigalway.ie.

In addition to my PhD experience, I became part of a group which I met through the Marie Keating Foundation, all of whom carry a BRCA mutation. The social support I get from these ladies is outstanding. We are a mixed bunch, all with different experiences, but I think that becoming a part of this group has helped enormously with my coping. Its a true gift to have such a vast array of experiences to learn from, both for my own personal BRCA journey, but also within the context of my research.

Almost four years after the death of her mother, and the discovery of her own genetic mutation, Niki would advise others who have recently been diagnosed to learn as much about the mutation as possible and seek support from others in the same situation.

Take time to process what youve just learned as I think its so important to try to frame it as a positive you may carry a BRCA mutation, but being aware of it and having the knowledge means you are at such an advantage compared to the generations before you, she says. Im lucky in that I have the chance now to take the preventative measures, and hopefully stay cancer-free.

Also, there are a few Facebook groups which are nice to be a part of, but predominately Ive found conferences such as the Marie Keating Foundations annual BRCA mutation conference and the BRCALink NI conference to be excellent events for learning about the most recent research in the field. Its also a great place to meet other people in similar circumstances.

The Marie Keating Foundation had planned to host its third annual BRCA Conference for men, women and their families that have tested positive for a BRCA gene mutation on April 24th in the Red Cow Moran Hotel in Dublin. It will now take place via webinar. Full details and registration is available at mariekeating.ie/events.

BRCA1 and BRCA2 are human genes which produce tumour suppressor proteins. These proteins help repair damaged DNA and, therefore, play a role in ensuring the stability of each cells genetic material. When this gene is mutated, these proteins are not produced properly and, as a result, cells are more likely to develop additional genetic alterations which can lead to cancer.

Both BRCA 1 and BRCA 2 gene mutation increase the carriers likelihood of developing cancer during their lifetime.

Female BRCA1 carriers have a 70 to 85 per cent risk of developing breast cancer during their lifetime, and a 40 to 50 per cent lifetime risk of ovarian cancer.

Males with BRCA1 mutation also have a slightly increased risk of breast cancer.

Female BRCA2 carriers have a 50 to 80 per cent risk of developing breast cancer during their lifetime and a 10 to 40 per cent lifetime risk of ovarian cancer.

Specific inherited mutations in BRCA1 and BRCA2 most notably increase the risk of female breast and ovarian cancers. People who have inherited mutations in BRCA1 and BRCA2 tend to develop breast and ovarian cancers at younger ages than people who do not have these mutations.

Men with BRCA2 mutations, and to a lesser extent BRCA1 mutations, are at increased risk of breast cancer and prostate cancer.

Due to a lack of data on BRCA-mutation carriers in Ireland, there are no comprehensive numbers for precisely how many people are BRCA positive in Ireland.

All women known to carry a BRCA1 or BRCA2 mutation are offered annual breast screening from age 30. Women age 30 are screened with annual MRI and, after the age of 40, digital mammogram is also performed. When a woman reaches 50 years, the radiologist will decide whether it is necessary to continue with MRI in addition to annual mammograms.

Three public hospitals offer genetics services to people considering BRCA testing in Ireland. The majority of genetic screening is carried out in the department of clinical genetics in Crumlin and St Jamess hospital Dublin.

Link:
BRCA1: Im lucky that I have the chance to take preventative measures - The Irish Times

Recommendation and review posted by Bethany Smith

PROVIDENCE, R.I. [Brown University] As novel coronavirus continues its sweep across the globe, among the most confounding aspects of the disease, COVID-19, and the causal virus, SARS-CoV-2, has been why symptoms are so severe for some patients yet milder for many others. Undoubtedly, age and underlying health conditions play a role but they dont account for fatalities among younger, otherwise healthy patients.

Physicians and scientists continue to publish data on cases, and one trend evident is that COVID-19 severity and fatalities tend to be greater among men than women. In one recent analysis of 13 U.S. states that report numbers of deaths among men and women, men died more frequently in every case.

In a letter to the editor in the journal Dermatologic Therapy, Dr. Carlos Wambier an assistant professor of dermatology and clinician educator at Brown Universitys Warren Alpert Medical School and a team of researchers from New York University, Applied Biology, Inc., and universities in Spain, India and Italy lay the groundwork for a hypothesis: the same male hormones that cause hair loss are linked to the vulnerability of patients to SARS-CoV-2.

While more research is needed to test that hypothesis, Wambier says a link between androgen hormones and COVID-19 could help to explain the higher severity for men and have implications for how health care providers test and treat patients. In the following Q&A, he shares more about the journal letter titled What does androgenetic alopecia have to do with COVID-19? An insight into a potential new therapy and what it might mean, if confirmed, for both patients and physicians.

The main insight is that excess activation of androgens essentially, hormones that regulate what we think of as male characteristics is intrinsically linked to the vulnerability of patients to SARS-CoV-2. This is because the first step to the viruss entry into a cell is a bite from a protease enzyme that is produced only by action of androgen hormones. The infection by SARS-CoV-2 seems to be mediated by androgens.

From a dermatological point of view, androgen receptors, which bind to DNA, have genetic variations that predispose individuals to hyperandrogenic features the receptor binds with more affinity to the male hormones. These hyperactive polymorphisms are very common and cause features such as scalp hair loss (androgenetic alopecia). Other clinical signs of excess male hormone activity include high density of facial or chest hair, acne and oily skin. It is intuitive to think that if the androgen receptor is hyperactive in an individual, that person will have more of a protease called TMPRSS2 in their cell surface, too and weve seen in early studies in the wake of novel coronavirus that TMPRSS2 is key to SARS-CoV-2 infection.

In other words, the scientific evidence gives us reason to believe that beardy, bald men may be more vulnerable to COVID-19 than other individuals.

Exactly. We currently know that men have more severe COVID-19 disease and a higher rate of fatality compared to women, and we also know that children under age 10 seem extremely resistant.

Before age 10, in normal conditions, neither girls or boys have increased androgens. The first androgens start to appear during a period called adrenarche, around age 8, but those androgens produced by the adrenal glands are not very potent. After age 10 comes puberty, and androgens rise, produced by the gonads increasing hair density in some areas, as well as oily scalp and acne. The peak of androgen production is in adult life, and they drop a little in the elderly. After menopause, women start to overexpress androgens, because of the huge drop of estrogen (female hormone), and there is an increase in facial hair and also a decrease in scalp hair density.

Taken together, this could help to explain why were seeing more severe and fatal COVID-19 cases in men, with a lower rate for women and very few for young children.

Q: What are the key pieces of evidence that point to the potential implication of androgens in the severity of COVID-19 cases?

In the journal article, we link two well-known scientific facts. First, that SARS-CoV-2 needs its spikes to be primed by the TMPRSS2 protease. Second, that the TMPRSS2 gene has only one known gene promoter, which is the androgen receptor. The gene requires androgen hormones to bind to the androgen receptor, so the cell can initiate the transcription of TMPRSS2 gene to produce the protease a cell-surface protein that eats other proteins. Without this protease, host cells are not infected with SARS-CoV-2 because the virus spikes cannot bind to ACE2, a receptor implicated in COVID-19 and severe acute respiratory syndrome. The protease eats the spikes so they can connect to the ACE2. So more androgen activity means more proteases, which we think leads to more severe infection.

Yes. Benign prostate enlargement is caused by a very potent androgen hormone, called DHT. This is the most potent natural androgen and it binds with great affinity to the androgen receptor making it express proteins like TMPRSS2, which has been studied for decades in prostate health and prostate cancer research and is now known to open the door to novel coronavirus.

Women also produce DHT and testosterone, though at much lower levels than men. However, due to ovary diseases such as PCOS or ovary adenomas, women can produce very high levels of male hormones. We know PCOS is related to obesity and diabetes, so women with these conditions and post-menopausal women are likely more susceptible to severe infections, following the androgen vulnerability rationale.

Im an expert in hair biology. I like to see hair growing in the scalp of my patients it is fun and gratifying. My colleague and co-author, Dr. Andy Goren, is a respected scholar in hair and Minoxidil research, and we often discuss insights and new therapy for hair growth and also diagnostic tools. In recent months, weve explored hair genetics and polymorphisms of androgen receptors and binding sites.

Then, the pandemic came, priorities changed and instead of doing cosmetic dermatology procedures, I felt the need to contribute however possible in protecting the lives of the health care professionals, soldiers, police officers and others who could be affected by COVID-19. Dr. Goren and I started to share ideas about targeting the coronavirus, and since we already knew a lot about TMPRSS2 expression, we began to research other mechanisms to explain male vulnerability, including changes in pulmonary surfactant proteins (which protect against influenza) and lung cells due to male hormones. We reviewed much of the early research on COVID-19 and our journal piece synthesizes our ideas with what we learned from SARS-CoV-2 studies into the hypothesis we present.

Im also part of a research team that will conduct a clinical trial for COVID-19 prophylaxis among volunteer health care workers in Rhode Island, where I am researching population vulnerability, with phenotype and genotype characteristics.

With a new target for therapy, clinical trials could be a next step several classes of anti-androgen drugs could hold promise for decreasing the severity of COVID-19. If confirmed, vulnerable subjects like men and women with androgenetic alopecia may be able to start prophylaxis or at least avoid risk environments for COVID-19, such as working in emergency departments or intensive care units for COVID-19 patients.

In the same way the U.S. Centers for Disease Control and Prevention recommended avoiding corticosteroids in COVID-19 patients, it might be important to avoid androgen hormones during the pandemic, particularly for police officers, health care workers and members of the military. Theres a link in that some corticosteroids also bind to androgen receptors. In addition, women who use progestogens for birth control that increase androgen activity (those that can cause acne or increased facial hair), might also consider contraceptive progestogens with anti-androgen activity.

To test this hypothesis, it would be informative to study the epidemiology of COVID-19 patients who are predisposed to either lower or higher androgen receptor expression, such as males with androgenetic alopecia or benign prostatic hyperplasia or women with PCOS. One of my hopes is that researchers publishing information about COVID-19 cases and cohorts can add precise data on male and female patients that had severe disease or fatal outcomes. For new research, it will also be important to evaluate signs of excess male hormones oily skin/hair, acne, facial hair and particularly scalp hair thinning or alopecia.

In addition, our research team is considering studying polymorphisms of androgen receptor in patients that presented mild vs. severe COVID-19 disease. As a plan for that research formalizes, well ultimately be looking for individuals diagnosed with COVID-19 who are willing to participate in clinical study.

Read more from the original source:
Conversations on COVID: Exploring genetic links to COVID-19 severity - Mirage News

Recommendation and review posted by Bethany Smith

B-roll for media use:

Carnivore keepers at the Smithsonian Conservation Biology Institute (SCBI) in Front Royal, Virginia, are about to welcome a litter of chirping cheetah cubs. Five-year-old female Echo is having contractions and birthed one cub already shortly after 11 a.m., which can be viewed via the Cheetah Cam. They were sired by 4-year-old Scott. Animal care staff will leave Echo to bond with and care for her cubs without interference, so it may be some time before they can determine the cubs sexes.

Staff are closely monitoring Echo and her cubs behaviors via webcam, which is now live on the Zoos website. Virtual visitors can observe Echo and her cubs on this temporary platform until the cubs leave the den. Keepers provided Echo with access to multiple dens, so it is possible she may move the cubs to an off-camera location. An Animal Cam Educational Packet is available to parents and educators looking for student and child home activities.

Its thrilling and humbling to witness something as special as an animal birth, said Steve Monfort, John and Adrienne Mars Director of the Smithsonians National Zoo and Conservation Biology Institute. Im eager to watch the newborn cubs in their early days. During this extremely tumultuous and isolating time, we want the new cheetah cam and all our live animal webcams to provide much needed moments of relief and inspiration from our natural world.

SCBI is part of the Cheetah Breeding Center Coalitiona group of 10 cheetah breeding centers across the United States that aim to create and maintain a sustainable North American cheetah population under human care. These cubs are a significant addition to the Association of Zoos and Aquariums Species Survival Plan (SSP) for Cheetahs, as each individual contributes to this program.

This was Echos first pregnancy, but were confident in her maternal instincts and abilities, said Adrienne Crosier, cheetah reproductive biologist at SCBI and head of the Cheetah SSP. She was raised by her own mother without human intervention, so theres a good chance Echo has learned cheetah parenting behaviors from the best teacherher mother.

The SSP scientists determine which animals to breed by considering their genetic makeup, health and temperament, among other factors. Echo and Scott were paired and bred Jan. 4 and 5. In February, keepers trained Echo to voluntarily participate in ultrasounds. SCBI veterinarians confirmed her pregnancy Feb. 26. Since 2007, 14 litters of cheetah cubs have been born at SCBI.

Cheetahs live in small, isolated populations mostly in sub-Saharan Africa. Many of their strongholds are in eastern and southern African parks. Due to human conflict, poaching and habitat and prey-base loss, there are only an estimated 7,500 to 10,000 cheetahs left in the wild. TheInternational Union for Conservation of Natureconsiders cheetahs vulnerable to extinction.

As a public health precaution due to COVID-19, the Smithsonians National Zoo and Conservation Biology Institute is temporarily closed to the public.Animal keepers and veterinary staff remain working on site at the Zoo and SCBI to provide the usual highest quality care for the animals.Additional information on the Zoos COVID-19 response is posted to the Zoos website. During the closure, the Zoo is sharing animal updates from behind the scenes using the hashtag #NatZooZen on Facebook, Instagram and Twitter.

The Zoos legacy of conservation work extends beyond the public Zoo in Washington, D.C., to SCBI in Front Royal, Virginia. Scientists at SCBI study and breed more than 20 species, including some that were once extinct in the wild, such as black-footed ferrets and scimitar-horned oryx. Animals thrive in specialized barns and building complexes spread over more than 3,200 acres. The sprawling environment allows for unique studies that contribute to the survival of threatened, difficult-to-breed species with distinct needs, especially those requiring large areas, natural group sizes and minimal public disturbance.

SCBI spearheads research programs at its headquarters in Virginia, the Zoo in Washington, D.C., and at field research stations and training sites worldwide. SCBI scientists tackle some of todays most complex conservation challenges by applying and sharing what they learn about animal behavior and reproduction, ecology, genetics, migration and conservation sustainability.

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Photo Credit: Smithsonian Conservation Biology Institute

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Cheetah Cubs Born at the Smithsonian Conservation Biology Institute - Smithsonian's National Zoo and Conservation Biology Institute

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Data: More men die of COVID-19 than women

An infectious disease expert says factors like men having more underlying health conditions than women are reasons why there is a disparity between male and female fatality rates with COVID-19.

BERKELEY, Calif. - New questions are emerging as the coronavirus continues to take livesand data in multiple parts of the worldshow that men withCOVID-19 have a higher fatality rate than women.

Inthe San Francisco Bay Area, SantaClaraCountyreported 1,224 confirmed cases Monday with a gender breakdown of52% menand48% women.The gender of those who died from COVID-19, however, show67%of the deathsin the countyare men.

A preliminary study fromChinaalso shows more malethan femalepatients dying fromCOVID-19and aWorld Health Organization Chartfor Italyand Spainhas a higher rate of death for men fromCOVID-19.

"There are several factors that contribute to this gender difference," saidDr. Lee Riley, a University of California atBerkeley professorand head of the division of Infectious Disease and Vaccinology at the school of Public Health.

Behavior could be one big factor, with men tending to smoke and drink alcohol more than women.

"That can contribute to different type of cardiovascular diseases and cardiovascular diseases themselves are also associated with bad outcomes in coronavirus infection," Riley said.

Santa Clara County statistics for 2014 show the ratio of smoking rates for men and women in the county are similar to the coronavirus fatality ratio.

Riley saidstudies show men also tend to wait longer than women to visit doctors.

"So by the time they get to a doctor, they may have more severe disease," said Dr. Riley.

Riley said there is researchthat indicates genetics might give women's immune systems an advantage,with twoX chromosomes.

"In the X chromosome there are a couple genes that are involved in the immune response whereas the males there's only one," he said.

Researchers sayCOVID-19 is not the only respiratory disease that shows a gender difference.

"The SARS epidemic we saw 17 years ago, again, there was a male predominance in deaths," Riley said."Tuberculosis is another major respiratory infectious disease and we see a ratio of 70 to 30, the disease being much more common in males."

Riley said as researchers look for vaccines and cures, it is important to collect and analyze data for genderand alsoanalyzedifferences in race and ethnicity.

"This particular coronavirus infection is greater among African Americans and people of ethnic minority backgrounds so those type of data are very important," Riley said.

InIllinois, health officials sayAfricanAmericans account for 30%of all coronavirus casesand inChicago,nearly 70%of the deaths are amongAfricanAmericans.MayorLoriLightfoot says the numbers highlight a longstanding disparity in health care access that needs to be addressed.Many of the victims haveother underlying health conditions.

Lousiana Governor John Bel Edwards announced that about 70% of the deaths in his state are African Americans and mentioned that hypertension was one of the factors in the deaths.

On Monday, theLawyersCommittee forCivilRightsUnder Law sent a letter toHealth and Human Services SecretaryAlex Azar.The letter calls forthe government to releasemore datato the public on the race and ethnicityof people with COVID-19.

Jana Katsuyama is a reporter forKTVU. Email Jana atjana.katsuyama@foxtv.comand follow her on Twitter@JanaKTVU

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Data: More men die of COVID-19 than women - KTVU San Francisco

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Sam Williams Macaw Recovery Network in Costa Rica rewilds captivity-hatched fledgling scarlet and great green macaws. But introducing young birds into a complex forest world bereft of the cultural education normally provided by parents is slow and risky.

For 30 years or so scientists have referred to the diversity of life on Earth as biological diversity, or just biodiversity. They usually define biodiversity as operating at three levels: the diversity of genes within any particular species; the diversity of species in a given place; and the diversity of habitat types such as forests, coral reefs, and so on. But does that cover it? Not really. A fourth level has been almost entirely overlooked: cultural diversity.

Culture is knowledge and skills that flow socially from individual to individual and generation to generation. Its not in genes. Socially learned skills, traditions and dialects that answer the question of how we live here are crucial to helping many populations survive or recover. Crucially, culturally learned skills vary from place to place. In the human family many cultures, underappreciated, have been lost. Culture in the other-than-human world has been almost entirely missed.

We are just recognising that in many species, survival skills must be learned from elders who learned from their elders. Until now, culture has remained a largely hidden, unrecognised layer of wild lives. Yet for many species culture is both crucial and fragile. Long before a population declines to numbers low enough to seem threatened with extinction, their special cultural knowledge, earned and passed down over long generations, begins disappearing. Recovery of lost populations then becomes much more difficult than bringing in a few individuals and turning them loose.

Many young birds learn much by observing their parents, and parrots probably need to learn more than most. Survival of released individuals is severely undermined if there are no free-living elder role models. Trying to restore parrot populations by captive breeding is not as easy as training young or orphaned creatures to recognise what is food while theyre in the safety of a cage then simply opening the door. In a cage, Williams says, you cant train them to know where, when and how to find that food, or about trees with good nest sites. Parents would normally have done exactly that.

A generational break in cultural traditions hampered attempts to reintroduce thick-billed parrots to parts of south-west America, where theyd been wiped out. Conservation workers could not teach the captive-raised parrots to search for and find their traditional wild foods, skills they would have learned from parents.

Landscapes, always complex, are under accelerated change. Culture enables adaptation far faster than genes alone can navigate hairpin turns in time. In some places, pigeons and sparrows have learned to use motion-sensors to get inside enclosed shopping malls and forage for crumbs. Crows have in some locales learned to drop nuts on the road for cars to crack. In at least one area they do this at intersections, so they can safely walk out and collect their cracked prizes when the light turns red and the cars stop. Theyve developed answers to the new question: How can we survive here, in this never-before world?

Because the answers are local, and learned from elders, wild cultures can be lost faster than genetic diversity. When populations plummet, traditions that helped animals survive and adapt to a place begin to vanish.

In a scientific article on the vocabulary of larks living in north Africa and Spain titled, Erosion of animal cultures in fragmented landscapes, researchers reported that as human development shrinks habitats into patches, isolation is associated with impoverishment. They write: Song repertoires pass through a cultural bottleneck and significantly decline in variety.

Unfortunately, isolated larks are not an isolated case. Researchers studying South Americas orange-billed sparrow found that sparrow song complexity the number of syllables per song and song length deteriorated as humans continued whittling their forests into fragments. When a scientist replayed 24-year-old recordings of singing male white-crowned sparrows at the same location shed recorded them, they elicited half the responses they had when first recorded. The birds responses show that changes in the dialect lead to changes in listener preference, a bit analogous to pop music. And as with humans, preferences can affect whether a particular bird will be accepted as a mate. White-crowned sparrows singing a local dialect become fathers of more offspring than do singers of unfamiliar dialects, indicating females prefer a familiar tune.

Im not just talking about a few songs. Survival of numerous species depends on cultural adaptation. How many? Were just beginning to ask such questions. But the preliminary answers indicate surprising and widespread ways that animals survive by cultural learning. Regionally different vocalisations are sometimes called song traditions but the more commonly used word is dialects. More than a hundred studies have been published on dialects in birds. And its not just birds but a wide array of animals Including some fish.

Cod particularly, said Steve Simpson of the University of Exeter, have very elaborate calls compared with many fish. You can easily hear differences in recorded calls of American and European Atlantic cod. This species is highly vocal with traditional breeding grounds established over hundreds or even thousands of years. Many fish follow elders to feeding, resting and breeding areas. In experiments, introduced outsiders who learned such preferred locales by following elders continued to use these traditional routes after all the original fish from whom they learned were gone.

Cultural survival skills erode as habitats shrink. Maintaining genetic diversity is not enough. Weve become accustomed to a perilous satisfaction with precariously minimal populations that not only risk genetic viability of populations but almost guarantee losing local cultural knowledge by which populations have lived and survived.

In all free-living parrots that have been studied, nestlings develop individually unique calls, learned from their parents. Researchers have described this as an intriguing parallel with human parents naming infants. Indeed, these vocal identities help individuals distinguish neighbours, mates, sexes and individuals; the same functions that human names serve.

Williams tells me that when he studied Amazon parrots, he could hear differences between them saying, essentially, Lets go, Im here, where are you? and Darling, I just brought breakfast. Researchers who develop really good ears for parrot vocalisation and use technology to study recordings show that parrot noise is more organised and meaningful than it sounds to beginners like me. In a study of budgerigars, for instance, birds who were unfamiliar with each other were placed together. Groups of unfamiliar females took a few weeks for their calls to converge and sound similar. Males copied the calls of females. Black-capped chickadees flock members calls converge, so they can distinguish members of their own flock from those of other flocks. The fact that this happens, and that it takes weeks, suggests that free-living groups must normally be stable, that groups have their own identity, and that the members identify with their group.

Group identity, we see repeatedly, is not exclusively human. Sperm whales learn and announce their group identity. Young fruit bats learn the dialects of the crowds theyre in. Ravens know whos in, whos out. Too many animals to list know what group, troop, family or pack they belong with. In Brazil, some dolphins drive fish toward fishermens nets for a share of the catch. Other dolphins dont. The ones who do, sound different from the ones who dont. Various dolphin groups who specialise in a food-getting technique wont socialise with other groups who use different techniques. And orca whales, the most socially complex non-humans, have layered societies of pods, clans and communities, with community members all knowing the members of all their constituent pods, but each community scrupulously avoiding contact with members of another community. All this social organisation is learned from elders.

Elders appear important for social learning of migratory routes. Various storks, vultures, eagles and hawks all depend on following the cues of elders to locate strategic migration flyways or important stopover sites. These could be called their migration cultures. Famously, conservationists have raised young cranes, geese and swans to follow microlight aircraft as a surrogate parent on first migrations. Without such enculturation, they would not have known where to go. The young birds absorbed knowledge of routes, then used them in later seasons on their own self-guided migrations. Four thousand species of birds migrate, so Andrew Whiten of the University of St Andrews in Scotland speculates that following experienced birds may be an underappreciated but very significant realm of cultural transmission.

When you look at free-living animals, you dont usually see culture. Culture makes itself visible when it gets disrupted. Then we see that the road back to reestablishing cultures the answers to the questions of how we live in this place is difficult, often fatal.

Young mammals too moose, bison, deer, antelope, wild sheep, ibex and many others learn crucial migration routes and destinations from elder keepers of traditional knowledge. Conservationists have recently reintroduced large mammals in a few areas where theyve been wiped out, but because animals released into unfamiliar landscapes dont know where food is, where dangers lurk, or where to go in changing seasons, many translocations have failed.

Williams describes his procedure with the macaws as very much a slow release. First his team trains the birds to use a feeder. With that safety net, they can explore the forest, gain local knowledge, begin dispersing and using wild foods.

Some rescue programmes declare success if a released animal survives one year. A year is meaningless for a bird like a macaw that doesnt mature until its eight years old, says Williams.

I ask what theyre doing for those eight long years.

Social learning, Williams replies immediately. Working out whos who, how to interact, like kids in school.

To gain access to the future, to mate and to raise young, the birds Williams is releasing must enter into the culture of their kind. But from whom will they learn, if no one is out there? At the very least they must be socially oriented to one another. Ex-pets are the worst candidates for release; they dont interact appropriately with other macaws, and they want to hang around near humans.

To assess the social abilities of 13 scarlet macaws who were scheduled for release, Williams and his crew documented how much time they spent close to another bird, how often they initiated aggression, things like that. When the bird scoring lowest for social skills was released, he flew out the door and was never seen again. The next-to-lowest didnt adapt to the free-living life and had to be retrieved. The third-lowest social scorer remained at liberty but stayed alone a lot. The rest did well.

All of the above adds up to this: a species isnt just one big jar of jellybeans of the same colour. Its different smaller jars with differing hues in different places. From region to region, genetics can vary. And cultural traditions can differ. Different populations might use different tools, different migration routes, different ways of calling, courting and being understood. All populations have their answers to the question of how to live where they live.

Sometimes a group will be foraging in a tree, Williams says. A pair will fly overhead on a straight path. Someone will make a contact call, and the flying birds will loop around and land with the callers. They seem to have their friends. Bottom line, said Williams, there is much going on in the social and cultural lives of his macaws and other species, much that they understand but we dont. We have a lot of questions. The answers must lurk, somewhere, in their minds.

As land, weather and climate change, some aspects of cultural knowledge will be the tickets necessary for boarding the future. Others will die out. Across the range of chimpanzees, cultures vary greatly, as do habitats. All populations but one use stick tools. Some use simple probes, others fashion multi-stick toolsets. Only one population makes pointed daggers for hunting small nocturnal primates called bush-babies hiding in tree holes. Only the westernmost chimpanzees crack nuts with stones.

As researchers have noted, distinctive tool-using traditions at particular sites are defining features of unique chimpanzee cultures. Whiten wrote: Chimpanzee communities resemble human cultures in possessing suites of local traditions that uniquely identify them A complex social inheritance system that complements the genetic picture.

Some chimpanzee populations have learned to track the progress of dozens of specific trees ripening in their dense forests. Others live in open semi-savannah. Some are more aggressively male-dominated, some populations more egalitarian. Some almost never see people; some live in sight of human settlements and have learned to crop-raid at night. For a long, long time chimpanzees have been works in progress. Weve learned, writes Craig Stanford, not to speak of The Chimpanzee. Chimpanzees vary and chimpanzee culture is variable at every level.

Its not just the loss of populations of chimps that worries me, Cat Hobaiter emphasised when I spent several weeks with her studying chimpanzees in Uganda. I find terrifying the possibility of losing each populations unique culture. Thats permanent.

Diversity in cultural pools perhaps more crucially than in gene pools will make species survival more likely. If pressures cause regional populations to blink out, a species odds of persisting dim.

Williams goal is to re-establish macaws where they range no longer, in hopes that they, and their forests, will recover. (Most of the central American forests that macaws need have been felled and burned, largely so fast-food burger chains can sell cheap beef.) It often takes a couple of generations for human immigrant families to learn how to function effectively in their new culture; it may take two or three generations before an introduced population of macaws succeeds. In other words, macaws are born to be wild. But becoming wild requires an education.

So whats at stake is not just numbers. Whats at stake is: ways of knowing how to be in the world. Culture isnt just a boutique concern. Cultural knowledge is what allows many populations to survive. Keeping the knowledge of how to live in a habitat can be almost as important to the persistence of a species as keeping the habitat; both are needed. Cultural diversity itself is a source of resilience and adaptability to change. And change is accelerating.

This is an edited extract from Becoming Wild: How Animals Learn to be Animals by Carl Safina, which published in the UK by Oneworld on 9 April and in the US by Henry Holt and Co on 14 April

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The secret call of the wild: how animals teach each other to survive - The Guardian

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