Researchers at Washington University School of Medicine in St. Louis have demonstrated a new gene therapy that builds strength and muscle mass quickly while preventing obesity even when the recipient is eating a high-fat diet. This isnt some crazy new bodybuilding tool, though, but rather something that could be used as a physical therapy aid for people with muscle-weakening arthritis or those suffering from osteoarthritis-related joint pain.

We know that obesity and joint injury are the primary risk factors for osteoarthritis, Farshid Guilak, professor of orthopedic surgery and director of research at Shriners Hospitals for Children in St. Louis, told Digital Trends. However, in cases of severe obesity or muscle loss, it is extremely difficult if not impossible to lose weight or improve muscle strength through normal exercise and diet. The goal of this study was to show the importance of muscle strength in overriding many of the harmful effects of obesity on the joint.

So far, the gene therapy approach has only been demonstrated in mice. The researchers delivered the gene for a molecule called follistatin to the muscle of eight-week-old mice, via injection. The protein blocks myostatin, a molecule normally responsible for stopping muscle growth. The mice in the experiment gained around twice their normal muscle mass and were able to completely burn off all the extra energy from an unhealthy high-fat diet. This prevented almost all the metabolic complications of obesity, such as systemic inflammation and high blood sugar, while also reducing arthritis and pain significantly.

The researchers worried that the gene therapy could potentially have a negative effect on the mices hearts. However, these fears proved unfounded and heart function in the mice actually improved, along with overall cardiovascular health.

These first studies in mice have shown that the procedure has excellent efficacy and safety, Guilak said. The next steps will be to do longer-term studies in mice and possibly larger animals to ensure safety of this procedure.

Guilak said that, should these steps prove successful, the researchers would consider testing the approach in humans with the initial trials in those with severe, possibly life-threatening diseases of the muscles, such as muscular dystrophy.

A paper describing the work was recently published in the journal Science Advances.

Visit link:
New gene therapy cuts fat and builds muscle with ease. But theres a catch - Digital Trends

Recommendation and review posted by Bethany Smith

PALO ALTO, Calif.andDURHAM Flush with cash, Kriya Therapeutics has big plans.

The biotech startup, with headquarters in Durham and Palo Alto, California, has secured $80.5 million in Series A financing to fund the development of its gene therapies for highly serious diseases.

Among them: type 1 and type 2 diabetes, severe obesity and other indications affecting millions of patients.

Series A investors include QVT, Dexcel Pharma, Foresite Capital, Bluebird Ventures (associated with Sutter Hill Ventures), Narya Capital, Amplo,Paul Manning, andAsia Alpha. This Series A round follows an initial seed financing completed by the company in the fourth quarter of 2019 led by Transhuman Capital, who also participated in the Series A round.

Kriya said financing proceeds would go towards supporting the development of the companys pipeline, internal discovery engine, and proprietary GMP manufacturing infrastructure.

There have been numerous successful gene therapies focused on rare monogenic diseases in recent years, said Shankar Ramaswamy, M.D., Co-Founder, Chairman, and CEO of Kriya Therapeutics, in a statement.

We see tremendous potential to expand the field and apply gene therapy to highly prevalent serious diseases. We are focused on designing gene therapies using algorithmic tools, scalable infrastructure, and proprietary technology to optimize the efficacy and durability of our treatments. We look forward to accelerating the development of our pipeline, platform technologies, and internal GMP manufacturing capability with the funds raised in this Series A financing.

Founded in 2019, the companys team includesformer senior leadership from Spark Therapeutics, AveXis, Sangamo Therapeutics, and other gene therapy companies.

Kriyas initial pipeline includes:

Kriya is building a leading team and cutting-edge infrastructure to engineer best-in-class gene therapies for severe chronic conditions and accelerate their advancement into human clinical trials, saidRoger Jeffs, Ph.D., Co-Founder and Vice Chairman of Kriya, in a statement.

The company is committed to incorporating the latest advancements in the field into the design and development of its therapeutic constructs. Through its R&D laboratory capabilities in the Bay Area and in-house process development and manufacturing infrastructure inResearch Triangle Park, I believe that Kriya will be uniquely positioned to become a leader in the gene therapy field.

See more here:
Durham's Kriya Therapuetics lands $80M to advance gene therapies for diabetes, severe obesity - WRAL Tech Wire

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]]> The company signed gene therapy deals with Novartis and Sarepta Therapeutics. Credit: Gerd Altmann from Pixabay.

Biotechnology company Dyno Therapeutics has launched from stealth mode with focus on using artificial intelligence (AI) technology to develop adeno-Associated Virus (AAV) vectors.

The company signed gene therapy deals with Novartis and Sarepta Therapeutics.

Dyno Therapeutics and Novartis will create improved AAV vectors for research, development and commercialisation of gene therapies across ocular diseases.

The partnership will leverage Dynos CapsidMap AI platform in combination with Novartis gene therapy development and global commercialisation expertise.

Dyno will use AI technology and its suite of machine learning and experimental tools to design and identify AAV capsids with improved functional properties for gene therapy.

Later, Novartis will carry out preclinical, clinical and commercialisation activities for the gene therapy candidates developed using the AAV capsids.

Dyno will gain upfront consideration, research funding, licence fees, along with potential clinical, regulatory and sales milestone payments.

Dyno Therapeutics CEO and cofounder Eric Kelsic said: With their extensive ophthalmologic expertise, Novartis is an ideal partner to leverage Dynos platform to design AI-powered vectors to expand the impact of gene therapies for ocular diseases.

This collaboration is a major step forward in our plan to realise the potential of Dynos CapsidMap platform for gene therapies to improve patient health.

Meanwhile, the company will work with Sarepta Therapeutics to use its CapsidMap platform to develop next-generation AAV vectors for muscle diseases.

Under the deal, Dyno will design and discover AAV capsids for gene therapy while Sarepta will conduct preclinical, clinical and commercialisation for product candidates resulting from the alliance.

Dyno could get more than $40m in upfront, option and licence payments during the research phase. Also, if Sarepta develops and commercialises product candidates for various muscle diseases, Dyno will receive milestone payments.

More:
Dyno Therapeutics launches with deals from Novartis and Sarepta - Pharmaceutical Technology

Recommendation and review posted by Bethany Smith

Repeated setbacks aside, little Capricor has suggested it has generated some long-term data to support its pursuit to garner approval for its stem cell therapy for Duchenne muscular dystrophy, although some of the data appeared to underwhelmed investors.

The data from the small, placebo-controlled mid-stage study, HOPE-2, tracked the effects of the companys stem cell therapy CAP-1002, which is designed to temper the inflammation associated with DMD, in 8 boys and young men who are in advanced stages of DMD. The remaining 12 enrolled patients received the placebo.

The main goal of the study was a measure that evaluates shoulder, arm and hand strength in patients who are generally non-ambulant (performance of the upper limb (PUL) 2.0), as suggested by the FDA, Capricor said. It is one of several ways Capricor quantified skeletal muscle improvement in the trial.

The intravenous infusion of CAP-1002, given every 3 months, induced a statistically meaningful improvement of 2.4 points (p=0.05) versus the placebo group, in which patient declines were consistent with natural history data. However, on another measure of upper limb function, the trend was in favor of the Capricor drug, but did not hit statistical significance.

The companys shares $CAPR were down nearly 13% to $6.89 in morning trading.

Click on the image to see the full-sized version

Meanwhile, there were also some encouraging data on cardiac function the genetic condition is characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles.

As reflected above, CAP-1002 elicited an improvement across different measures of cardiac function, although the effect was not always statistically significant. In particular, the drug also caused a reduction in the levels of the biomarker CK-MB, an enzyme that is only released when there is cardiac muscle cell damage.

Armed with these data and an RMAT and orphan drug designation from the FDA, Capricor is now hoping to eke out a plan with the FDA for marketing approval.

LA-based Capricor initially set out to test the potential of technology that Eduardo Marbn, CEO Linda Marbns husband, developed at Johns Hopkins. But repeated setbacks clobbered the company, which in 2014 traded north of $14 a share. In 2017, J&J walked away from a collaboration on a stem cell therapy for damaged hearts after it flopped in the clinic.

In late 2018, the company voluntarily halted a DMD clinical trial, following a severe allergic reaction that occurred during infusion. In February 2019, the company said it is exploring strategic alternatives for one or more of its products and cutting 21 jobs to keep financially afloat, but had resumed dosing in its DMD trial.

The first batch of positive data on CAP-1002, which consists of progenitor cells derived from donor hearts and is designed to exude exosomes that initiate muscle repair by suppressing inflammation and driving immunomodulation, came last July when the company announced the drug had generated a positive effect at the interim analysis juncture of HOPE-2. Capricor is now working on to flexing its therapeutic muscle with CAP-1002 to fight the Covid-19 pandemic.

DMD is a rare muscle-wasting disease caused by the absence of dystrophin, a protein that helps keep muscle cells intact. It disproportionately affects boys and affects roughly 6,000 in the United States.

Patients are essentially treated with steroids. Sarepta Therapeutics now has two exon-skipping drugs designed to treat certain subsets of the disease, although the magnitude of their effect is controversial given that approvals were not based on placebo-controlled data. Meanwhile, Sarepta and others are also pursuing one-time cures in the form of gene therapies to replace the missing dystrophin gene in patients.

Social: Linda Marbn, Capricor CEO (Twitter)

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One year on, Capricor's stem cell therapy appears to help DMD patients in small study, but investors balk at the data - Endpoints News

Recommendation and review posted by Bethany Smith

Global Gene Therapy for Age-related Macular Degeneration Market research report provides detail information about Market Introduction, Market Summary, Global market Revenue (Revenue USD), Market Drivers, Market Restraints, Market Opportunities, Competitive Analysis, Regional and Country Level.

Gene Therapy for Age-related Macular Degeneration Market Size Covers Global Industry Analysis, Size, Share, CAGR, Trends, Forecast And Business Opportunity.

>>Need a PDF of the global market report? Visit: https://industrystatsreport.com/Request/Sample?ResearchPostId=11998&RequestType=Sample

Latest research report on Gene Therapy for Age-related Macular Degeneration Market delivers a comprehensive study on current market trends. The outcome also includes revenue forecasts, statistics, market valuations which illustrates its growth trends and competitive landscape as well as the key players in the business.

Macular degeneration is a condition in which, macula, a part of the retina, gets damaged or deteriorated. This condition usually affects individuals who are aged 50 years and above and therefore, it is called age-related macular degeneration (AMD). AMD is the leading cause of vision loss and is directly related to the advancement of age. But smoking also plays a vital role in causing AMD. AMD is characterized by the presence of a blurred area near the center of vision that leads to distorted vision. There are two different types of AMD, including dry (atrophic) AMD (dAMD) and wet (neovascular/exudative) AMD (wAMD). The dAMD is the most common type of AMD and accounts for almost 80%-90% of the overall AMD cases.

It has been observed that age-related macular degeneration (AMD) is one of the major causes for vision loss and is characterized by the formation of a blurred area near the center of vision, a condition that mostly affects the geriatric population. According to the CDC, almost 2 million individuals in the US suffer from AMD and by 2050, this number will reach more than 5 million. This will subsequently demand the need for the development of innovative treatments for AMD, driving the markets growth.

The market research analysts have predicted that with the introduction of techniques such as fluorescein angiography, the global age-related macular degeneration market will register a CAGR of more than 7% by 2020. With the unavailability of FDA-approved treatment for dry AMD (dAMD) and the treatment of wet AMD (wAMD) involving the need of intravitreal injections for an indefinite period, gene therapy is emerging as the most-efficient approach for the treatment of age-related macular degeneration (AMD).

According to this pipeline analysis report, most of the gene therapy molecules in the pipeline are being developed for wet AMD (wAMD). Our market research analysts have also identified that most of these molecules are in the pre-clinical development stage and a considerable number of molecules have been discontinued from development.

This report focuses on the global Gene Therapy for Age-related Macular Degeneration status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Gene Therapy for Age-related Macular Degeneration development in United States, Europe and China.

The key players covered in this study RetroSense Therapeutics REGENXBIO AGTC

Market segment by Type, the product can be split into Subretinal Intravitreal Unspecified

Market segment by Application, split into Monotherapy Combination Therapy

In this study, the years considered to estimate the market size of Gene Therapy for Age-related Macular Degeneration are as follows: History Year: 2014-2018 Base Year: 2018 Estimated Year: 2019 Forecast Year 2019 to 2025

Market segment by Regions/Countries, this report covers United States Europe China Japan Southeast Asia India Central & South America

The study objectives of this report are: To analyze global Gene Therapy for Age-related Macular Degeneration status, future forecast, growth opportunity, key market and key players. To present the Gene Therapy for Age-related Macular Degeneration development in United States, Europe and China. To strategically profile the key players and comprehensively analyze their development plan and strategies. To define, describe and forecast the market by product type, market and key regions.

For the data information by region, company, type and application, 2018 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

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Table of Content:

Market Overview: The report begins with this section where product overview and highlights of product and application segments of the Global Gene Therapy for Age-related Macular Degeneration Market are provided. Highlights of the segmentation study include price, revenue, sales, sales growth rate, and market share by product.

Competition by Company: Here, the competition in the Worldwide Global Gene Therapy for Age-related Macular Degeneration Market is analyzed, By price, revenue, sales, and market share by company, market rate, competitive situations Landscape, and latest trends, merger, expansion, acquisition, and market shares of top companies.

Company Profiles and Sales Data: As the name suggests, this section gives the sales data of key players of the Global Gene Therapy for Age-related Macular Degeneration Market as well as some useful information on their business. It talks about the gross margin, price, revenue, products, and their specifications, type, applications, competitors, manufacturing base, and the main business of key players operating in the Global Gene Therapy for Age-related Macular Degeneration Market.

Market Status and Outlook by Region: In this section, the report discusses about gross margin, sales, revenue, production, market share, CAGR, and market size by region. Here, the Global Gene Therapy for Age-related Macular Degeneration Market is deeply analyzed on the basis of regions and countries such as North America, Europe, China, India, Japan, and the MEA.

Application or End User: This section of the research study shows how different end-user/application segments contribute to the Global Gene Therapy for Age-related Macular Degeneration Market.

Market Forecast: Here, the report offers a complete forecast of the Global Gene Therapy for Age-related Macular Degeneration Market by product, application, and region. It also offers global sales and revenue forecast for all years of the forecast period.

Research Findings and Conclusion: This is one of the last sections of the report where the findings of the analysts and the conclusion of the research study are provided.

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Covid 19 Pandemic: Gene Therapy for Age-related Macular Degeneration Market Size is Thriving Worldwide- Demand and Analysis 2019-2025 - Cole of Duty

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Doctors in Southern California are working with researchers in Arizona to better understand the bodys sometimes bizarre immune response to COVID-19 an antibody onslaught that may kill the patient, rather than kill the virus.

The nonprofit Translational Genomics Research Institute (TGen), an affiliate of City of Hope, is peering into specific proteins on the virus to see how they react with different antibodies a high-resolution view that might guide treatment, testing and vaccine development.

The hypothesis is that antibodies can make things worse, and thats whats killing some people, said John Altin, assistant professor in TGens infectious-disease branch. We want to understand how that might be different from an immune response that protects somebody.

As many critically ill patients are treated in clinical trials with convalescent plasma therapy that is, injecting antibodies from recovered COVID-19 patients into those who are very ill, in hopes of triggering protective immune responses its imperative to understand whats behind the differing reactions.

Usually, antibodies provide protection, but there may be a bit of an exception with this virus, Altin said. That is a serious concern.

To that end, TGen and the Center for Gene Therapy at City of Hope are cooperating on a COVID Immunity Study that aims to collect blood from COVID-19 survivors.

The researchers will analyze your blood and profile your immune memory, the study consent form explains.

Participants can use the TGen kit at home. Theyll get a study kit by mail and collect one small spot blood sample, via a finger-prick device, for two consecutive weeks. Then theyll mail the study kit back to TGen.

About 500 people are expected to participate through the course of the study, and researchers may reach out for additional samples, and/or with additional questions, to see how immune memory changes over time.

Participants must be U.S. residents, at least 18 years old, have tested positive for COVID-19, and then recovered. For more information, see https://covidimmunity.org/.

This will help us learn more about how, when and why we produce antibodies in response to a COVID-19 infection, said David Engelthaler, director of TGen North, in a prepared statement. One class of antibodies tackles the infection first, and then another comes in to finish the job. Knowing when these different immune responses occur, and how long they last, could help us understand if some patients gain a certain degree of immunity against reinfection. We need to know how that works.

While large-scale clinical trials involving convalescent plasma are under way all over the nation, this study aims not to treat the disease, but to better understand the mechanisms behind it.

TGen describes its approach as a high-resolution view of the antibody response. It seeks to not only map the viruss proteins in detail, but to also see which parts of those proteins are targeted by antibodies.

Our approach will not only tell you which proteins arebeing targeted, but also be able to tell which regions of each protein are being targeted, Altin said in a statement. Each protein can be recognized by many different types of antibodies. By looking at this level of detail, we then could see elements of the antibody response that others might be missing.

TGen hopes to tease out subtle differences that can help develop therapies, vaccines and better antibody testing.

Others are looking at responses to the entire protein. Our approach is a little different. When we look at the antibody response, we divide it up into thousands of pieces. Theres potential for that to tell us what a beneficial and un-beneficial response might look like, Altin said.

John Zaia, director of the Center for Gene Therapy at City of Hope, is working with TGen, and has other COVID-19-related projects happening as well.

Zaia is leading a research project at City of Hope, in collaboration with Altins lab, that could lead to development of a COVID-19 virus antibody neutralization test, which would quantify antibodies.

Zaia also has received a $750,000 grant from the California Institute for Regenerative Medicine for a clinical study on the use of blood plasma as a potential treatment for COVID-19.

Theyre doing what you could call qualitative and quantitative measurements of the nature of the antibody what does it actually bind to? Zaia said. The virus has this surface protein, the spike protein, but there are also other things the immune system might be seeing. It might be focused on one or more parts of the spike.

The CIRM project will focus on finding plasma donors to determine if theres any correlation between the outcome in the sick patient who received the plasma and the specific antibody that went in. It will focus on under-served areas.

Duarte-based City of Hope was founded in 1913 and is a founding member of the National Comprehensive Cancer Network. It has many sites throughout Southern California, and is investing $1 billion to establish clinics and a cancer center in Orange County. A clinic opened in Newport Beach in January, and a hospital dedicated to cancer treatment and research is slated for Irvine.

On the forefront of science, new discoveries are made every day and so much is still unknown.

I think the FDA said it best: Theres no way that one group could solve all the problems, do all the testing that needs to be done, Zaia said. The whole field is so new.

Theres a balance that must be struck between moving quickly and moving carefully, Altin said. We should know a lot in the next three months about how the antibody response looks, he said. Vaccine development will take much longer.

See original here:
Why does immune response to coronavirus save some, kill others? - East Bay Times

Recommendation and review posted by Bethany Smith

The Gene Therapies for Cancer Treatment market report provides a thorough analysis of this business landscape based on the consumption and production aspects. With respect to consumption, the report reviews the product consumption value as well as the product consumption volume alongside the individual sales trends of each product during the forecast period. In addition, details regarding the import and export graphs across the various geographies are also provided in the report.

According to Latest Research Report on Gene Therapies for Cancer Treatment Market size | Industry Segment by Applications (Cancer Research Centers,Diagnostic Laboratories,Cancer Hospitals andOthers), by Type (Somatic Cell Gene Therapy (SCGT) andGermline Gene Therapy (GGT), Regional Outlook, Market Demand, Latest Trends, Gene Therapies for Cancer Treatment Industry Share, Research Growth Forecast & Revenue by Manufacturers, The Leading Company Profiles, Growth Forecasts 2026.

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Based on the production aspect, the report covers the manufacturing of the product, its revenue, and gross margins garnered by the market majors. Variation in unit costs strategized by these manufacturers across various regional markets during the analysis period are also entailed in the report.

A brief of the regional outlook:

An overview of the product spectrum:

A gist of the application terrain:

Insights regarding the competitive terrain:

In summary, the Gene Therapies for Cancer Treatment market report is evaluated through several categorizations, including the basic industry definitions. Information pertaining the upstream raw materials, downstream buyers, and distribution channels of the competitors are discussed in the report. The study also examines the key drivers, restraints and opportunities that will impact the growth trends in the ensuing years.

Highlights of the Report:

Key Questions Answered in the Report Include:

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Gene Therapies for Cancer Treatment Market Report, History and Forecast 2015-2026, Breakdown Data by Manufacturers, Key Regions, Types and Application...

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Scientists have found in a new study that men who have lower levels of testosterone have a higher risk of dying from coronavirus if they ever catch the disease. In the study, researchers have discovered that in 45 COVID-19 patients admitted in the intensive care unit in a German hospital, testosterone plays a crucial role in their survival against the deadly virus.

Researchers found that the broad majority of men admitted had significantly low testosterone levels. Without an ample supply of the sex hormone, the body won't be able to regulate its immune response, which could lead to a deadly 'cytokine storm.' They have found that testosterone may be capable of keeping the body's immune system from going out of control.

In the study, the researchers evaluated the first 45 COVID-19-positive patients admitted to the ICU at the University Medical Center Hamburg-Eppendorf. Thirty-five of the patients were men, while ten were women. Seven of the patients required oxygen, and 33 of them required the use of ventilation.

Before the patients received any invasive procedures, their hormone levels were assessed on their first day of admission to the ICU. Samples from the patients were tested for 12 hormones, along with testosterone and dihydrotestosterone.

Of the male COVID-19 patients sent to ICU at the German hospital, more than 68% recorded low levels of testosterone. On the contrary, the majority of female patients had elevated testosterone levels. Of all the participants in the study, nine men and three women died.

Although low levels of testosterone can not curb the immune response in men, the study found that in female COVID-19 patients, higher testosterone levels were linked to a more compelling inflammatory response.

The sex hormone is known to aid in controlling the body's immune response. However, when a man has low levels of testosterone, the immune system is not at its best and can lead to further damage when contracting an infection.

This could possibly lead to a so-called cytokine storm, which occurs when the immune system goes berserk as it tries to kill the pathogen. A cytokine storm eventually begins injuring the body itself and, if left alone, can cause death.

Read Also: Testicles Are Serving as 'Reservoirs' For Coronavirus Making Men More At Risk of Longer and Severe Case of COVID-19: Study

Hypogonadism in men is a condition where the body doesn't produce enough of the sex hormone, testosterone. The hormone plays a crucial role in masculine growth and development during puberty.

Some men are born with hypogonadism, while others develop them later on in life, usually from infection or injury. Some types of the condition can be treated with testosterone replacement therapy.

The condition can undoubtedly reduce the quality of life and, in some cases, has resulted in the loss of livelihood and separation of couples. Testosterone has many vital actions involved in metabolism, vasculature, and brain function. Furthermore, the hormone also has well-known effects on bone and body composition.

Statistics prove that coronavirus seems to hit men harder than women. Experts say that some of it may be due to the behavior of men when it comes to tobacco smoke and drinking alcohol. Such lifestyle and behavior could predispose them to have more underlying diseases than women.

Another behavioral factor to consider is that men tend to seek medical care later in the course of disease than women do. Most women tend to act fast and consult their physicians right away, while men display the 'macho' attitude and avoid going to see their doctor as much as possible.

Biological factors could play a part in this too. Professionals say that men have weaker immune systems and that sex hormones involved in the process of how the immune system starts an inflammatory response to pathogens may also be involved.

Also Read: COVID-19 Male Patients to Receive Female Sex Hormones Estrogen and Progesterone To See if They Could Help Reduce Severity

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Men With Hypogonadism Leading to Low Testosterone Levels are More Likely to Die From the Coronavirus, Study Fi - Science Times

Recommendation and review posted by Bethany Smith

Therapeuticsmd

Moreover, the Male Hypogonadism Therapy report offers a detailed analysis of the competitive landscape in terms of regions and the major service providers are also highlighted along with attributes of the market overview, business strategies, financials, developments pertaining as well as the product portfolio of the Male Hypogonadism Therapy market. Likewise, this report comprises significant data about market segmentation on the basis of type, application, and regional landscape. The Male Hypogonadism Therapy market report also provides a brief analysis of the market opportunities and challenges faced by the leading service provides. This report is specially designed to know accurate market insights and market status.

By Regions:

* North America (The US, Canada, and Mexico)

* Europe (Germany, France, the UK, and Rest of the World)

* Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

* Latin America (Brazil and Rest of Latin America.)

* Middle East & Africa (Saudi Arabia, the UAE, , South Africa, and Rest of Middle East & Africa)

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Table of Content

1 Introduction of Male Hypogonadism Therapy Market

1.1 Overview of the Market1.2 Scope of Report1.3 Assumptions

2 Executive Summary

3 Research Methodology

3.1 Data Mining3.2 Validation3.3 Primary Interviews3.4 List of Data Sources

4 Male Hypogonadism Therapy Market Outlook

4.1 Overview4.2 Market Dynamics4.2.1 Drivers4.2.2 Restraints4.2.3 Opportunities4.3 Porters Five Force Model4.4 Value Chain Analysis

5 Male Hypogonadism Therapy Market, By Deployment Model

5.1 Overview

6 Male Hypogonadism Therapy Market, By Solution

6.1 Overview

7 Male Hypogonadism Therapy Market, By Vertical

7.1 Overview

8 Male Hypogonadism Therapy Market, By Geography

8.1 Overview8.2 North America8.2.1 U.S.8.2.2 Canada8.2.3 Mexico8.3 Europe8.3.1 Germany8.3.2 U.K.8.3.3 France8.3.4 Rest of Europe8.4 Asia Pacific8.4.1 China8.4.2 Japan8.4.3 India8.4.4 Rest of Asia Pacific8.5 Rest of the World8.5.1 Latin America8.5.2 Middle East

9 Male Hypogonadism Therapy Market Competitive Landscape

9.1 Overview9.2 Company Market Ranking9.3 Key Development Strategies

10 Company Profiles

10.1.1 Overview10.1.2 Financial Performance10.1.3 Product Outlook10.1.4 Key Developments

11 Appendix

11.1 Related Research

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Male Hypogonadism Therapy Market Growth by Top Companies, Trends by Types and Application, Forecast to 2026 - Cole of Duty

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Since the COVID-19 infection flare-up in December 2019, the malady has spread to right around 100 nations around the world with the World Health Organization proclaiming it a general wellbeing crisis. The worldwide effects of the coronavirus sickness 2019 (COVID-19) are now beginning to be felt, and will essentially influence the Healthcare Industry in 2020.

According to Persistence Market Researchs new report, globalmale hypogonadism marketis slated to exhibit a steady expansion throughout the forecast period (2017-2026). Revenues from the global market for male hypogonadism are estimated to exceed US$ 3,300 Mn by 2026-end.

Governments Taking Initiatives to Spread Awareness about Male Hypogonadism Therapeutics

Lack of sex hormones, usually referred to as male hypogonadism has resulted into many health risks that include osteoporosis, heart disease, and cardiovascular diseases on the back of thinning of bones. Global male hypogonadism market comprises several patented brands that currently have high market penetration. Proliferation in geriatric population in tandem with rising incidences related to rheumatoid arthritis and obesity have been primary factors affecting prevalence of male hypogonadism globally.

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Company Profiles

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Mounting incidences of testosterone deficiency in male population is a key factor that prevalence of male hypogonadism has surged worldwide. Several governments around the world have been taking initiatives to spread the awareness on hypogonadism treatment procedures, for example testosterone replacement therapy (TST), in order to relieve the painful burden on patients and their families.

As low testosterone levels are increasingly associated with exacerbation of chronic conditions, it further results into disorders apropos to hypothalamic-pituitary-gonadal axis. Advent of TST has however enabled reduction in cases of male hypogonadism considerably. With growing awareness related to its treatment among patients, the market is likely to gain an uptick during the forecast period.

Rising availability of the selective androgen receptor modulators (SARMs) has further sustained the market expansion. The development and high availability of SARMs has led toward the provision of improved treatment procedure to patients having androgen deficiencies, thereby influencing the market growth.

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North America will continue to Dominate Global Male Hypogonadism Market

North America will continue to dominate the global male hypogonadism market, with more than one-third revenue share during the forecast period. In addition, revenues from the male hypogonadism market in North America will exhibit the fastest expansion through 2026, as compared to those from all the other regional segments comprised in the report. Europe and Asia-Pacific excluding Japan (APEJ) are also expected to remain lucrative for the male hypogonadism market. The market in APEJ will ride on a slightly higher CAGR than that in Europe through 2026.

Topical gels are expected to remain the most lucrative among drugs available for treatment of male hypogonadism globally, with sales projected to register the fastest expansion through 2026. Injectables will also remain a major revenue contributor to the market. Sales of injectable and transdermal patches are poised to reflect an equal CAGR through 2026.

Testosterone Replacement Therapy to Remain Preferred among Patients

Based on therapy, testosterone replacement therapy is expected to remain preferred among patients with male hypogonadism worldwide. Roughly 66% revenue share of the market is expected to be held by revenues from testosterone replacement therapy by 2026-end. Revenues from gonadotropin replacement therapy will remain slightly more than half revenues gained from testosterone replacement therapy throughout the forecast period.

Klinefelters syndrome is expected to remain the most prevalent disease type observed in the male hypogonadism market, and revenues from treatment of this disease will exceed US$ 1,800 Mn by 2026-end. Kallmann Syndrome and Pituitary Adenomas among disease types will also account for major revenue shares of the market by 2026-end.

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3d Cell Cultures Market3d Cell Cultures Market Segmented By Extracellular Matrices or Scaffolds, Bioreactors, Gels, Scaffold-free Platforms, Microchips Technology in Research, Drug development and testing, Tissue engineering, Clinical application, Stem cell biology.For More Information.

Cranio Maxillofacial Implants MarketCraniomaxillofacial Implants Market Segmented By Plate and Screw Fixation Systems, Distraction Systems, Temporomandibular Joint Replacement Devices, Flap Fixation Devices and Bone Graft Substitutes with Calcium Ceramics, Polymers, Metals and Alloys, Biological Materials.For More Information

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Male Hypogonadism Market to Witness over CAGR Growth in Revenue During the COVID-19 Pandemic - Germany English News

Recommendation and review posted by Bethany Smith

A Scunthorpe mum who underwent 'brutal' stem cell treatment says the hardest part was not being able to see her daughters.

Joanne While has recently passed the six month anniversary of the treatment to wipe out and then regrow her immune system.

The mum-of-three was diagnosed with Multiple Sclerosis (MS) at the age of 31, and wasn't eligible for trial treatments in the UK.

The HSCTtreatment in Mexico saw her undergo chemotherapy and then have stem cells transplanted in the hopes of stopping the damage that the MS was causing. Some MS patients have also seen their symptoms be reversed from this.

"It was a very harsh, brutal treatment. I had to be kept in a special apartment where I protected from all germs. There was a lot of sickness and just getting out of bed some days was difficult," Joanne said.

"The hardest part was being away from my family. My ex-partner was very kind in taking a months unpaid leave to come to Mexico and help me through the treatment.

"At the end of the day, all of the treatment has been worth it.

"I had a brain MRI scan two months ago which showed that the MS lesions hadnt grown since last time. My body is still recovering, so time will tell exactly how good the news is."

The HSCT (haematopoietic stem cell transplantation) treatment cost the family 45,000 including flights and visas. They launched an online fundraising page last year to help cover the costs.

With her weak immune system still being rebuilt, Joanne has been shielding since before the coronavirus outbreak began.

Her family have adopted extremely strict hygiene measures at the Scunthorpe home to keep her healthy during this critical time.

HSCT is a chemotherapy-based medical procedure that wipes out the immune system and reboots it using a patient's own stem cells, which are harvested from their blood or bone marrow,

The aim is to reset the immune system to stop it attacking the rest of the body, therefore halting the progression of the MS.

It is the only medical procedure currently available that has halted the progression of the majority of patients undertaking it.

HSCT is currently available only on a trial basis in the UK, and only for individuals who have been unsuccessful with the range ofdisease modifying therapies. Each time it fails, irreparable damage is being done and the disease continues to progress.

"Before the outbreak, it had just gotten to the point where I was able to venture out for a coffee, but of course all of that has stopped now," Joanne said.

"I had to pull my daughters out of school early to minimise the risk of them bringing the virus home. Now we regularly sanitise the house and change clothes whenever we have to enter or leave in order to keep it as clean as possible.

"My eldest daughter, who is 24, has been wonderful as my carer. She has stopped work to prevent her from catching any infections.

"Im often tired and need a three hour nap in the afternoon, which can be difficult with a five-year-old in the house. Its been a balancing act, but Im so grateful to everyone who helped me during or since the treatment.

"Shielding can be frustrating, but its all about your mindset when you look at it. Its not that I cant go outside I get to be at home in my favourite place with my daughters."

Due to her compromised immune system, Joanne has had to start her vaccinations again and has just been given those that are usually given to babies.

Tests have also shown that her white blood count has recently decreased to the point it was in Mexico, although Joanne has hopeful it will recover.

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HSCT can initially cause mobility issues and stiffness in muscles, which Joanne is having physio to manage.

She is documenting her recovery on her Facebook page 'Jo's HSCT Journey'.

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Mum's brutal stem cell treatment has 'all been worth it' as she enjoys time with family - Grimsby Live

Recommendation and review posted by Bethany Smith

ALBANY, New York, May 11, 2020 /PRNewswire/ -- As a result of growing pandemic of COVID-19, the pharmaceutical industry is investing a major amount in research and development of an effective vaccine that can help the doctors to save lives and help controlling the pandemic. As per a recent analysis by Transparency Market Research over pharmaceutical sector, it was found that the global autologous cell therapy market is witnessing a major push. The market is projected to grow exponentially during the tenure of 2019 to 2027 and is expected to witness a substantial 18.1% CAGR during this tenure. Moreover, the global autologous cell therapy market is expected to register a value of US$ 34.7 Bn by the end of 2027, says a recent report by Transparency Market Research.

"COVID-19 has impacted the economy at global level. With the death tolls still on the rise in developed and developing countries, the pandemic nowhere seems to get stop. However, the pharmaceutical sector is constantly investing in research and development. Nevertheless, the industry is majorly investing in autologous cell therapyto find an effective cure for CORONA Virus. Owing to these research and development, the global autologous cell therapy market is projected to grow exponentially during the tenure of 2019 to 2027" Transparency Market Research.

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Major Finding in Global Autologous Cell Therapy Market Study

Explore the latest study on global autologous cell therapy market under the title: Autologous Cell Therapy Market (Source - Bone Marrow and Epidermis; Application - Neurology, Orthopedics, Cancer, Wound Healing, CVD, and Autoimmune; End User - Hospitals, Ambulatory Centers, and Research Centers) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2019 2027 at https://www.transparencymarketresearch.com/report-toc/715

Major Drivers Propelling the Growth of Global Autologous Cell Therapy Market

Growing cases of Neurological Disorders to Propel the Growth

The world is witnessing a massive growth in the number of patients suffering from neurological diseases. The report by Transparency Market Research states that there are more than 50 Mn people suffering from autoimmune disorder which can cause a painful death. In order to develop an effective drug that can help the neurological patients, the pharmaceutical industry is investing massive in autologous cell therapywhich as a result is propelling the growth of global autologous cell therapy market during the tenure of 2019 to 2027.

Strong Government Support to Boost the Growth of the Autologous Cell Therapy Market

Governments across the globe are encouraging pharmaceutical industry to develop an effective cure for Parkinson's, nervous breakdowns, and most importantly COVID-19. This has significantly helped the players to develop new drugs. Owing to this support, the global autologous cell therapy market shall witness a substantial growth during the tenure of 2019 to 2027, states the report by Transparency Market Research.

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Major Challenges Mentioned in the Global Autologous Cell Therapy Market

The major challenge that might impede the growth of global autologous cell therapy market is the cost of the therapy. Since the cost of therapy is quite high, the some of the patient might not be able to afford it which might deplete the growth of global autologous cell therapy market during the tenure of 2019 to 2029. However, with ongoing research and development in the pharmaceutical industry, there are high chances that the world might see a cost effective therapy in the global autologous cell therapy market in future.

Global Autologous Cell Therapy: Regional Analysis

North America shall account for the largest share in the global autologous cell therapy market in future. It is noticeable that the regional front of the global autologous cell therapy market was dominated by this particular region in 2018. This dominance is the result of improving healthcare infrastructure, technological development and supportive government efforts. Owing to these factors the global autologous cell therapy market is expected to be dominated by North America during the tenure of 2019 to 2027.

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Competitive Analysis

The global autologous cell therapy market is highly progressive yet highly consolidated. The nature of the market is the result of presence of AA handful of prominent players. However, due to this the new players are unable to enter the global autologous cell therapy market. To overcome this situation, the new players are merging and collaborating with the established players of global disposable face mask market.

The global autologous cell therapy market is segmented in the basis of:

Global Autologous Cell Therapy Market, by Source

Global Autologous Cell Therapy Market, by Application

Global Autologous Cell Therapy Market, by End-user

Global Autologous Cell Therapy Market, Region

Explore Transparency Market Research's award-winning coverage of the global Healthcare industry:

Autoimmune Disease Diagnostics Market- the global autoimmune diseases diagnostics market is expected to exhibit a CAGR of 3.8%. The global autoimmune disease diagnostics market is likely to reach US$17.06 bn by 2023. The stiff price competition among players is expected to impact the growth of the market in a negative way.

Stem Cells Market- The global market for stem cells is projected to reach a value of US$270.5 bn by the end of 2025. The market is likely to exhibit a strong 13.80% CAGR between 2017 and 2025

Cell Therapy Market-The study reports an insight about the global cell therapy market, along with its current and the past market situation. This enables the customers to comprehend the situation before entering or investing in the market. The report gives driving components fueling the development of the market, restrictions which are probably going to limit the market development, and so forth.

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Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through adhoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

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Growing Number of Patients Suffering From Neurological Disorder to Support the Growth of Global Autologous Cell Therapy Market, TMR - PRNewswire

Recommendation and review posted by Bethany Smith

For anyone who has been struggling with skin issues, it can be very frustrating. Whether you have cracked cuticles that the most high-end moisturizer wont heal or eczema, it can be difficult to find a cure-all that helps fight issues across the board. The world might not have a cure for everything yet, but tea tree oil balm does work wonders on many skin issues. If youre tired of using harsh chemicals to try to fix your problems, you might want to try tea tree oil balm.

You only need a little bit of the balm, which is harder and less flexible than a cream or oil, to cover the afflicted area. Tea tree oil balm usually does not go on greasy and stays put all day long to heal and restore the skin. It works on many problems, including cracked cuticles, dry skin, severely chapped lips, calluses, athletes foot, bug bites, psoriasis, eczema, hives and itchy skin. Basically, tea tree oil balm is great to keep on your bedside or in your purse for any skin emergency. You can even use it proactively, because it can serve as a great light-weight moisturizer. It cant hurt to keep boosting your skins protective barrier.

We found the best tea tree oil balms thatll provide relief to your stressed out skin. These balms use natural ingredients to help your skin. This is the MVP of natural skincare.

Our mission at STYLECASTER is to bring style to the people, and we only feature products we think youll love as much as we do. Please note that if you purchase something by clicking on a link within this story, we may receive a small commission of the sale and the retailer may receive certain auditable data for accounting purposes.

This small but mighty 60-gram tin works on just about everything from cracked cuticles to eczema. Absorbent and not greasy, this balm heals and softens skin. Its tiny enough to fit in a small purse, so you can take it with you wherever you go. Chamuels balm is made of tea tree oil, green tea, peppermint oil, lemon oil, olive oil and beeswax. It doesnt contain any harsh chemicals, parabens or artificial ingredients. The balm has a slight fresh, citrus smell, but it isnt overpowering.

Image: Amazon

This Wonder Balm is primarily made of oils, including tea tree, eucalyptus, macadamia, olive oil and beeswax. Its designed to restore your skins protective barrier and provide relief of your skin. It also heals dry skin, especially on your feet, hands and elbows. When you sweat, your creams often sweat away but that isnt the case for this balm. The lightweight, non-greasy formula stays put even when youre moving. This cream doesnt contain any preservative, parabens or petroleum.

Image: Amazon

This balm includes tea tree oil, fruit stem cells, almond oil, eucalyptus oil and lavender oil. The balm works hard to restore balance and repair your skin. It can help with annoyances such as razor burn, dry ashy skin, psoriasis, severely chapped lips and bug bites. You do need to use a little bit of elbow grease to get this hard, firm balm out of the container, but it does work well after that.

Image: Amazon

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The Best Tea Tree Oil Balm That You Can Buy on Amazon - STYLECASTER

Recommendation and review posted by Bethany Smith

Novadip Biosciences Reports Positive Interim Analysis of Phase I/II Bone Non-Union Study with NVD003

Mont-Saint Guibert, Belgium, 13 May, 2020: Novadip Biosciences (Novadip or the Company), a clinical-stage biopharmaceutical company leveraging its proprietary tissue regeneration technology platform, today announces positive data from the interim analysis of its Phase I/IIa clinical trial for autologous NVD-003 in adults with non-healing fracture of the lower limb.

NVD-003 is a novel autologous cell-based osteogenic (bone healing/[bone forming]) product that has been generated from Novadips proprietary 3M tissue regeneration platform. This platform is aimed at healing damaged tissues by restoring their natural physiology and consists of a 3-dimensional, scaffold-free extracellular matrix (ECM), utilizing differentiated adipose-derived stem cells (ASCs) to restore the physiology of natural healing. NVD003 presents as a scaffold-free 3D implant to fill critical-size bone defects where healing is compromised.

This phase I/II study is investigating in five European centers the potential of NVD-003 to promote bone union in nine adults with a non-healing fracture of the lower limb. There was 100% manufacturing success for NVD-003 and grafting surgery was completed successfully in all patients without deviating from standard medical practice. To date, with a median of 12 months post-treatment, no NVD003 related safety signal has been reported. Further exploratory analysis performed on data from the first five patients to complete a six month follow up showed a strong positive trend in radiological healing with confirmed bone formation for all patients and radiologically confirmed union for three of the patients.

Prof. Gunnar Anderson (MD, PhD), Professor and Chairman Emeritus of the Department of Orthopedic Surgery at Rush University Medical Center, Chicago, Illinois and Chairman of the Scientific Advisory Board commented: The early results of this study are remarkable both clinically and for the patients and we look forward to replicating these in a larger group in the future. It is hugely encouraging that we may potentially have a future solution for these patients with unmet needs.

Dr. Denis Dufrane (MD, PhD), Chief Executive Officer, Chief Scientific Officer commented: We are encouraged by the data from this interim analysis, which demonstrates the potential of our tissue regeneration 3M3 platform to restore natural healing processes in patients with reputedly difficult to treat bone defects. We look forward to further progressing NVD-003s clinical program in bone non-union and in patients with other similar conditions with no effective treatment option and hope to provide full study results in 2025.

NVD-003 is also in clinical stage for congenital pseudarthrosis of the tibia (CPT), a rare and disabling pediatric condition with very limited treatment options and has demonstrated clinical proof-of-concept in case studies.

Novadips tissue regeneration platform drives several new classes of product candidates with an initial focus on autologous cell therapies for critical size tissue reconstruction. Allogeneic therapeutics are in development for prevalent and complex tissue defects for bone and skin tissue and exosomes/miRNA-based therapeutics are being developed for immediate (off-the-shelf) clinical use.

- End -

Notes to editors

Novadip Biosciences

Novadip Biosciences is a clinical stage biopharmaceutical company leveraging its unique 3D tissue regeneration technology platform to generate multiple product candidates to address hard and soft tissue reconstruction for patients who have limited or no treatment options. The companys proprietary 3M3 platform is a 3-dimensional, extracellular matrix that utilizes adipose-derived stem cells to deliver highly-specific growth factors and miRNAs to mimic the physiology of natural healing and creates a range of products that address specific challenges in tissue regeneration. Novadips initial focus is on critical size bone reconstruction. The company is also applying its 3M3 platform to develop truly novel off-the-shelf/allogeneic therapies to address more prevalent tissue defects and miRNA/exosome products for broader indications. For more information, visit http://www.novadip.com .

For further information, please contact:

Novadip Biosciences

Denis Dufrane

Chief Executive Officer, Chief Scientific Officer

+32 (10) 779 220

info@novadip.com

For media enquiries:

Consilium Strategic Communications

Chris Gardner, Matthew Neal, Angela Gray

+44 (0) 20 3709 5700

novadip@consilium-comms.com

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Novadip Biosciences Reports Positive Interim Analysis of Phase I/II Bone Non-Union Study with NVD003 - GlobeNewswire

Recommendation and review posted by Bethany Smith

Carlos R. Bachier, MD

Chimeric antigen receptor (CAR) T-cell therapies quickly burst into the spotlight of hematology-oncology disease management because of their potential to illicit deep and durable responses from patients whose disease is relapsed or refractory to multiple previous lines of therapy. Relevant professional meetings and oncology publications exploded with research and news about CAR T cells, and this cellular therapy strategy is now being explored across hematologic and solid malignancies.

CAR T cells are a scientific revolution, Tania Jain, MBBS, assistant professor of oncology at Johns Hopkins University in Baltimore, Maryland, said in an interview with Targeted Therapies in Oncology (TTO). They have brought about a paradigm shift in terms of how were treating patients.

The 2 currently FDA-approved CAR T-cell therapies, axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), are both indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma; additionally, tisagenlecleucel is approved for patients up to 25 years with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1-3 With a second wave of approvals likely on the horizon for therapies such as lisocabtagene maraleucel (liso-cel) and idecabtagene vicleucel (bb2121), CAR T is gaining traction and will likely play an increasingly prominent role in the future treatment paradigm in oncology.

CAR T-cell therapy administration is largely limited to the inpatient setting at both academic institutions and large accredited cancer centers, making such treatments unavailable to most patients. Other challenges with this type of therapy include its potential to cause serious toxicities resulting in organ damage and death.4

David G. Maloney, MD, PhD

Due to the promising efficacy of these agents, investigators have been working toward viable solutions to bring CAR T-cell therapies to more patients by alleviating difficulties associated with therapy delivery and patient care.

CAR T-cell therapies, both those currently approved and the many being explored in late-phase clinical trials, are produced from autologous T cells obtained from the patient receiving therapy. This personalization has led to tremendous success, yet it is a large part of why CAR T-cell therapy use remains limited to a select group of patients.

Time is an important consideration for patients who have experienced multiple relapses and may be too weakened by numerous lines of prior therapy to wait several weeks for the CAR T-cell manufacturing process. The effects of previous treatments or the disease itself can also present challenges, as manypatients are rendered lymphopenic and may be unable to produce enough T cells for harvesting. Roadblocks may remain for patients who are not limited by these factors; manufacturing success and effectiveness of the CAR T-cell product can be negatively influenced by disease-related dysfunctions of patients T cells.4

A new option, off-the-shelf CAR T-cell products, may help solve these problems. These premade products are manufactured using allogeneic donor cells (instead of autologous cells from the patient), and they present immediate advantages to clinicians, such as immediate availability, opportunity for product standardization, and decreased cost.5

The advantages [include] being able to access the cellular therapy in real time, as opposed to autologous products that havetobe manufactured,Craig S. Sauter, MD, clinical director of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center in New York, New York, explained in an interview withTTO. This is particularly important for patients who are not responding to therapy, which is a current requirement for treatment with CAR T cells, he added.

Findings from a phase I trial (NCT01430390) in patients with relapsed or refractory B-cell malignancies showed that patients with non-Hodgkin lymphoma (NHL) experienced durable responses with an Epstein-Barr virusspecific cytotoxic lymphocyte CAR product derived from cells harvested from third-party donors (rather than from their more precisely matched stem cell donors). All 4 patients with NHL and a single patient with chronic lymphocytic leukemia, who were treated with third-party cells, remained disease free and alive at the time of analysis, with a median follow-up of over 2 years.6

The advantages [of this type of therapy are] that it eliminates the need for apheresis [and] shipping cellular products back and forth. [Instead, clinicians] have a pharmaceutical product on the shelf for access, Sauter, who was an author on the trial, said. Another notable product being investigated in clinical trials is UCART19, an allogeneic engineered anti CD19CAR T-cell product, which is being evaluated in the phase I CALM trial in adult patients with relapsed or refractory B-cell ALL (NCT02746952) and in the phase I PALL trial of pediatric patients with relapsed or refractory CD19-positive B-cell ALL (NCT02808442). Other off-the-shelf agents are described in theTABLE.5

Issues with inpatient CAR T-cell therapy administrationinclude high demands on health care resources and strain on patients and their families. Moving treatment to the outpatient setting has the potential to reduce this strain; however,clinicians taking over care of patients receiving CAR T-cell therapy must be prepared with the proper resources to identify and manage adverse events associated with therapy.

One of the most notable risks to patients receiving CAR T-cell therapy is cytokine release syndrome (CRS), a systemic inflammatory response that is characterized by increased serum levels of inflammatory cytokines, fever, hypotension, hypoxia, and organ dysfunction.4 [CAR T] can also lead to neurological events and can cause confusion and, in some patients, seizures,Carlos R. Bachier, MD, Director of Cellular Research at Sarah Cannon Cancer Center in Nashville, Tennessee, explained in an interview with TTO.

Regardless of the infusion setting, patients require close monitoring in the hours and days following therapy administration. A review byLucrecia Yez, PhD, MS, and colleagues stated that key criteria for treating patients in the outpatient setting include an educated caregiver and necessary infrastructure allowing for outpatient visits plus adequate emergency and intensive care unit (ICU) access. Patients followed as outpatients must be given twice-daily temperature checks for a minimum of 14 days following treatment and preferably extending up to 3 to 4 weeks following infusion. Anysigns of back pain, skin rash, dizziness, chills, shortness of breath, chest pain, tachycardia, or neurological events that may indicate neurotoxicity or signs of CRS must be reported immediately so treatment can begin as quickly as possible.7

Because of the risk of CRS and neurotoxicity, both FDA-approved agents are restricted under the Risk Evaluation and Mitigation Strategy, an FDA-mandated program that builds in caution for use of agents with serious safety concerns.8,9 Therefore, 2 doses of tocilizumab (Actemra), an interleukin (IL)-6 receptor antagonistthat was approved in 2017 for management of CRS associated with CAR T-cell therapy,1,4 should be on hand for each patient before the infusion of CAR T cells. Steroids have also demonstrated efficacy against CRS, but concernssurrounding CAR T-cell suppression with these agents have established them as a second-line choice after tociluzumab.9

Immune effector cellassociated neurotoxicity syndrome (ICANS) is a group of neurologic symptoms associated with treatments such as CAR T-cell therapy. Predisposing factors include younger age, higher tumor burden, high levels of pretreatment inflammation, and history of early or high-grade CRS. Treatments for complications of ICANS vary. Some centers may prescribe prophylactic antiepileptic medications, such as levetiracetam, to prevent seizures in patients with grade 2 or higher neurologic events. AntiIL-6 therapy can be considered in patients with concurrent CRS, but corticosteroids are the preferred regimen in those with neurotoxicity alone.9

In February of this year, the investigational CAR T-cell product liso-cel was granted priority review by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma who had undergone at least 2 prior therapies.10 Investigators believe that liso-cel therapy may have a place in a broad range of patients and in the outpatient setting.11

It turns out liso-cel has a low incidence of [CRS and ICANS], and they occurred relatively late compared with other products, said Bachier. Because of this low incidence, the strategy was to deliver liso-cel in an outpatient setting.

The feasibility of liso-cel administration on an outpatient basiswas evaluatedby Bachier and colleagues, and the results were presented at the 2020 Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood & Marrow Transplant Research, held February 19 to 23, 2020, in Orlando, Florida.12

The authors analyzed data from 3 clinical trials of liso-cel, with a focus on the subset of participants who were treated as outpatients. The included trials were the phase I TRANSCEND-NHL-001 (NCT02631044) and phase II OUTREACH (NCT03744676) trials in patientswhohadundergone at least 2 lines of prior treatment, as well as the PILOT study (NCT03483103), which examined liso-cel as second-line therapy in patients who were ineligible for autologous hematopoietic stem cell transplant because of age, organ function, or ECOG performance score. All 3 studies allowed outpatienttreatment, with some patients receiving their therapy in the nonuniversity setting.

This clinical trial included sites that were not a part of a university but had experience treating patients for stem cell transplant, Bachier said. Some of these sites that participated were notyour traditional university centers that had traditionally been involved in the development of these therapies.

Much caution was required in order to maximize patient safety and treatment efficacy. The approach of doing CAR T-cell therapy, in general, in the outpatient setting requires a robust clinical ability of the centers, said coauthor David G. Maloney, MD, PhD, medical director of Cellular Immunotherapy at the Immunotherapy Integrated Research Center of Fred Hutchinson Cancer Research Center in Seattle, Washington, in an interview. We were able to get people safely to the hospital, and it was rare that you would have to do escalation of care when people were admitted. Most of the time, patients could bemanagedand wereout of the ICU, withrare exceptions. But again, you still have to have the wherewithal to get patients to the ICU pot entially for aggressive care if needed.

Results of the analysis of outpatient data from the 3 trials showed that rates of toxicity and response were similar to those previously reported for the entire patient cohort (both inpatients and outpatients) of the TRANSCEND-NHL-001 trial.

Based on these results, the indication is that you can deliver [liso-cel] in the outpatient setting and the outcomes are good compared with those treated in the inpatient setting, said Bachier. Aside from that, it also showed that liso-cel could be safely administered outside of university programs and in more community-based programs, most of them being aligned [with] or part of stem cell and bone marrow transplant programs.

When planning or setting up a CAR T-cell therapy outpatient program, investigators anticipate possible barriers to successfultreatment. The greatest barrier, according to Bachier, is access to physicians and staff who are knowledgeable and trained to manage toxicities related to CART-cell therapy. These therapies still should not, in my opinion, be delivered [by clinicians in] community centers that do not have the expertise to deliver the therapies safely, he said.

Maloney added that centers should be required to have the ability to triage patients 24/7 and allow for patients to be directly admitted to the hospital if needed. In the case of the analysis of outpatient data from the 3 liso-cel trials however, he said, We found that around 30% to 40% of patients did not actually ever require hospitalization, whichis quite interesting. Most of the 60% to 70% of patients who were hospitalized were admitted for fever, he added.

In addition, sites must gain accreditation and approval, Jain pointed out.

Every center that intends to do CAR T-cell therapy is first approved by each of the companies [that manufacturethese agents], Jain said. The centers also have to be approved by FACT [Foundation for the Accreditation of Cellular Therapy], which is the same organization that approves centers for allogeneic stem cell transplant. These are some of the largest things that a center needs to go through, which takes care of things like developing standard practices and other guidelines to make sure that these [therapies] are used safely and appropriately.

As investigators and oncologists explore the feasibility of moving CAR T-cell therapy into more settings, 2 questions arise: What settings have on this therapy?

What type of training and skills do clinicians need? Like other clinicians, Sauter has concerns about new allogeneic cellular therapies,andhe hopes future research will focus on mitigating these challenges. The concern would be that these are not autologous products and there is the risk of rejection from the host immune system, he said. Strategies to circumnavigate that risk are at the forefront of investigationin off-the-shelf CAR T cells.

The research is not stopping with CAR T-cell therapy,though. Were seeing a lot of new molecules coming in that will be challenging the roles of CAR T cells, [such as] specific antibodies, which may even work in cases of CAR T-cell failure, Maloney said. We are still learning how to make those more effective and safer.

References:

1. FDA approves tisagenlecleucel for B-cell ALL and tocilizumab for cytokine releasesyndrome.FDAwebsite.PublishedAugust30,2017.AccessedApril14, 2020. bit.ly/2RC4eQ8

2. FDA approves axicabtagene ciloleucel for large B-cell lymphoma. FDA website. Published October 18, 2017. Accessed April 14, 2020. bit.ly/2yYIQOp

3. FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma. FDA website. Published May 1, 2018. Accessed April 14, 2020. bit.ly/34zPoi8

4. Rafiq S, Hackett CS, Brentjens RJ. Engineering strategies to overcome the current roadblocks in CAR T cell therapy. Nat Rev Clin Oncol. 2020;17(3):147167. doi: 10.1038/s41571-019-0297-y

5. DepilS,DuchateauP,GruppSA,MuftiG,PoirotL.Off-the-shelfallogeneic CAR T cells: development and challenges. Nat Rev Drug Discov. 2020;19(3):185199. doi: 10.1038/s41573-019-0051-2

6. Curran KJ, Sauter CS, Kernan CS, et al. Durable remission following off-theshelf chimeric antigen receptor (CAR) T-cells in patients with relapse/refractory (R/R) B-cell malignancies. Presented at: 2020 Transplantation & Cellular Therapy Meetings; February 19-23, 2020; Orlando, FL. Abstract 120. bit.ly/2ufDYCu

7. Yez L, Snchez-Escamilla M, Perales MA. CAR T cell toxicity: current managementandfuturedirections. Hemasphere.2019;3(2):e186.doi:10.1097/ HS9.0000000000000186

8. Risk evaluation and mitigation strategies | REMS. FDA website. Updated August 8, 2019. Accessed April 14, 2020. bit.ly/2ykhLVt

9. JainT,BarM,KansagraAJ,etal.UseofchimericantigenreceptorTcell therapy in clinical practice for relapsed/refractory aggressive B cell non-Hodgkin lymphoma: an expert panel opinion from the American Society for Transplantation and Cellular Therapy. Biol Blood Marrow Transplant. 2019;25(12):2305-2321. doi: 10.1016/j.bbmt.2019.08.015

10. U.S. Food and Drug Administration (FDA) accepts for Priority Review Bristol-Myers Squibbs Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B-cell lymphoma. News release. Bristol-Myers Squibb; February 12, 2020. Accessed April 15, 2020. bit.ly/37ruQbs

11. Helwick C. Strong activity shown for lisocabtagene maraleucel CAR T-cell therapy in aggressive large B-cell lymphoma. ASCO Post website. Published February 25, 2020. Accessed April 15, 2020. bit.ly/3eoD0pT

12. Bachier CR, Palomba ML, Abramson JA, et al. Outpatient treatment with lisocabtagene maraleucel (liso-cel) in 3 ongoing clinical studies in relapsed/refractory (R/R) large B cell non-Hodgkin lymphoma (NHL), including second-line transplant noneligible (TNE) patients: TRANSCEND NHL 001, OUTREACH, and PILOT. Presented at: 2020 Transplantation & Cellular Therapy Meetings; February 19-23, Orlando, FL. Abstract 29. bit.ly/37I7DC9

Link:
Protocol Management, Off-the-Shelf Therapies Help Bring CAR T Into More Settings - Targeted Oncology

Recommendation and review posted by Bethany Smith

- The global autologous cell therapy market is expected to witness a massive 18.1% CAGR during the tenure of 2019 to 2029

- During the tenure of 2019 to 2027, the global autologous cell therapy market shall rise from 7.5 Bn in 2018 to US$ 34.7 Bn by the end of 2027

ALBANY, New York, May 11, 2020 /PRNewswire/ -- As a result of growing pandemic of COVID-19, the pharmaceutical industry is investing a major amount in research and development of an effective vaccine that can help the doctors to save lives and help controlling the pandemic. As per a recent analysis by Transparency Market Research over pharmaceutical sector, it was found that the global autologous cell therapy market is witnessing a major push. The market is projected to grow exponentially during the tenure of 2019 to 2027 and is expected to witness a substantial 18.1% CAGR during this tenure. Moreover, the global autologous cell therapy market is expected to register a value of US$ 34.7 Bn by the end of 2027, says a recent report by Transparency Market Research.

"COVID-19 has impacted the economy at global level. With the death tolls still on the rise in developed and developing countries, the pandemic nowhere seems to get stop. However, the pharmaceutical sector is constantly investing in research and development. Nevertheless, the industry is majorly investing in autologous cell therapyto find an effective cure for CORONA Virus. Owing to these research and development, the global autologous cell therapy market is projected to grow exponentially during the tenure of 2019 to 2027" Transparency Market Research.

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Major Finding in Global Autologous Cell Therapy Market Study

Explore the latest study on global autologous cell therapy market under the title: Autologous Cell Therapy Market (Source - Bone Marrow and Epidermis; Application - Neurology, Orthopedics, Cancer, Wound Healing, CVD, and Autoimmune; End User - Hospitals, Ambulatory Centers, and Research Centers) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2019 2027 at https://www.transparencymarketresearch.com/report-toc/715

Major Drivers Propelling the Growth of Global Autologous Cell Therapy Market

Growing cases of Neurological Disorders to Propel the Growth

The world is witnessing a massive growth in the number of patients suffering from neurological diseases. The report by Transparency Market Research states that there are more than 50 Mn people suffering from autoimmune disorder which can cause a painful death. In order to develop an effective drug that can help the neurological patients, the pharmaceutical industry is investing massive in autologous cell therapywhich as a result is propelling the growth of global autologous cell therapy market during the tenure of 2019 to 2027.

Strong Government Support to Boost the Growth of the Autologous Cell Therapy Market

Governments across the globe are encouraging pharmaceutical industry to develop an effective cure for Parkinson's, nervous breakdowns, and most importantly COVID-19. This has significantly helped the players to develop new drugs. Owing to this support, the global autologous cell therapy market shall witness a substantial growth during the tenure of 2019 to 2027, states the report by Transparency Market Research.

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Major Challenges Mentioned in the Global Autologous Cell Therapy Market

The major challenge that might impede the growth of global autologous cell therapy market is the cost of the therapy. Since the cost of therapy is quite high, the some of the patient might not be able to afford it which might deplete the growth of global autologous cell therapy market during the tenure of 2019 to 2029. However, with ongoing research and development in the pharmaceutical industry, there are high chances that the world might see a cost effective therapy in the global autologous cell therapy market in future.

Global Autologous Cell Therapy: Regional Analysis

North America shall account for the largest share in the global autologous cell therapy market in future. It is noticeable that the regional front of the global autologous cell therapy market was dominated by this particular region in 2018. This dominance is the result of improving healthcare infrastructure, technological development and supportive government efforts. Owing to these factors the global autologous cell therapy market is expected to be dominated by North America during the tenure of 2019 to 2027.

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Competitive Analysis

The global autologous cell therapy market is highly progressive yet highly consolidated. The nature of the market is the result of presence of AA handful of prominent players. However, due to this the new players are unable to enter the global autologous cell therapy market. To overcome this situation, the new players are merging and collaborating with the established players of global disposable face mask market.

The global autologous cell therapy market is segmented in the basis of:

Global Autologous Cell Therapy Market, by Source

Global Autologous Cell Therapy Market, by Application

Global Autologous Cell Therapy Market, by End-user

Global Autologous Cell Therapy Market, Region

Explore Transparency Market Research's award-winning coverage of the global Healthcare industry:

Autoimmune Disease Diagnostics Market- the global autoimmune diseases diagnostics market is expected to exhibit a CAGR of 3.8%. The global autoimmune disease diagnostics market is likely to reach US$17.06 bn by 2023. The stiff price competition among players is expected to impact the growth of the market in a negative way.

Stem Cells Market- The global market for stem cells is projected to reach a value of US$270.5 bn by the end of 2025. The market is likely to exhibit a strong 13.80% CAGR between 2017 and 2025

Cell Therapy Market-The study reports an insight about the global cell therapy market, along with its current and the past market situation. This enables the customers to comprehend the situation before entering or investing in the market. The report gives driving components fueling the development of the market, restrictions which are probably going to limit the market development, and so forth.

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Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through adhoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

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Growing Number of Patients Suffering From Neurological Disorder to Support the Growth of Global Autologous Cell Therapy Market, TMR - P&T Community

Recommendation and review posted by Bethany Smith

In a new study from the University of Exeter, researchers have identified a hybrid lobster species with both American and European genes.

According to study co-author Dr. Charlie Ellis, the discovery has potentially concerning implications for the lobster industry and conservation efforts, and further research is needed to assess the extent of the threat.

Lobsters imported from North America have been washing up on European shores in recent years. Experts have feared that the American lobsters may establish themselves as a native species or spread disease.

There have also been concerns about the negative effects of hybridization, but lab studies suggested that the European and American lobsters were not likely to mate.

Now, the offspring of a female American lobster found in a fjord in Sweden have been genetically identified as being clearly distinct from both European and American lobsters.

We had just developed a genetic test for seafood traceability that could separate any American lobsters mislabeled as more expensive European equivalents once theyve been cooked and shell coloration is no longer a useful indicator of the species, said Dr. Ellis.

What we found when we tested these offspring is that they came out exactly in the middle of this separation half American and half European so these lobsters were hybrids.

Until recently, it was thought that American and European lobsters would avoid crossbreeding, but this introduced American female has mated with a native European male, probably because she was unable to find an American male.

We now need to check whether any mature adult hybrids are fertile, because if they are then they have the ability to spread these unwanted American genes far and wide across our native lobster stocks.

According to the researchers, the study highlights the vital use of genetics to distinguish hybrid lobsters which might look almost identical to a pure strain.

It is particularly concerning that we seem to have found American lobster genes in one of our lobster reserves, said study co-author Linda Svanberg.

The better news is we now have this genetic tool to test lobsters or their eggs for hybridisation, so we can use it to track the spread of these alien genes to assess how big a threat this presents to our native lobster species, said study lead author Dr. Jamie Stevens.

For a range of conservation reasons, including potential contact with American lobsters, the researchers advise that the general public should never release a marketed lobster back into the wild.

Although we appreciate that all animal-lovers have concern for the fate of individual animals, in this case the rescue of one animal might endanger the health of the entire wild population, so once a lobster has entered the seafood supply chain thats where it should stay, said Dr. Tom Jenkins.

The study is published in the journal Scientific Reports.

By Chrissy Sexton, Earth.com Staff Writer

See the rest here:
Hybrid lobster species discovered with new genetic test Earth.com - Earth.com

Recommendation and review posted by Bethany Smith

With the help of a mouse model, researchers have found that the immune responses in a female before pregnancy can help predict how her offsprings are to have behavioural deficits if the immune system is activated during pregnancy. The results of the study could help resolve what role serious infections during pregnancy play in the later development of conditions such as autism and schizophrenia in the offspring.

The researchers from the Center for Neuroscience at the University of California, Davis co-authored the study findings published in the journal Brain, Behavior, and Immunity. Both genetics and a variety of environmental risk factors are thought to play a role in mental illness, said Professor Kim McAllister, director of the Center for Neuroscience and senior author on the paper.

"Most pregnancies are resilient, although the risk from maternal immune activation is low, it could provide a way into the underlying problems that lead to schizophrenia or autism," she said. "Our research focuses on how to predict which pregnancies are at risk and discover new ways to intervene and prevent disease in offspring."

The first evidence for a role for maternal infection in mental and developmental disorders came from the influenza epidemic of 1918, McAllister said. Epidemiological studies 15 to 20 years later of children who were in gestation at the time showed an increase in these disorders. Other evidence comes from animal studies.Apart from influenza, a wide variety of viruses and bacteria have been implicated in maternal immune activation. So the effect is more likely due to the mother's reaction to infections than with the infectious organism itself.

To reproduce this in mice, McAllister's team doses pregnant mice with a molecule called polyinosinic:polycytidylic acid, or poly (I:C), which is double-stranded RNA, the genetic material for many viruses including influenza and coronaviruses. The immune system recognizes poly (I:C) as if it were a virus and triggers an immediate inflammatory response, especially releasing a molecule called interleukin-6, or IL-6.

The mice continue with the pregnancy and when the offspring are about 2 months old, the researchers test them for behavioural abnormalities, such as repetitive behaviours or freezing in place. Professor Judy Van de Water, an immunologist at the UC Davis School of Medicine and part of Estes' thesis committee, suggested looking at baseline immune reactivity in the mice before they became pregnant.

When they did that, the team found that the IL-6 response of a particular mouse to poly (I:C) before it became pregnant could predict the likelihood of behavioural problems in offspring if the mouse were treated with poly (I:C) later during pregnancy. "People assume that their mice are all the same, but there is clearly a wide range of baseline immunoreactivity," McAllister said. That baseline immunoreactivity turns out to predict resilience or susceptibility to immune activation during pregnancy.

"We can dose them with poly (I:C) and look at the IL-6 response and predict which ones will have affected offspring if we treat them during pregnancy," she said.With a reliable model for resilience and susceptibility, researchers can start to work out what genes and proteins involved in brain development are affected by immune activation and how this could lead to neurodevelopmental disorders. "The next steps are to figure out what it is that is different about those mice," McAllister said.

"Now that we can predict which mice are at risk, we want to determine how specific patterns of immune signalling in the mom cause distinct outcomes in offspring. We are hoping to figure out how maternal infection can lead to no problem in many pregnancies and to a range of distinct diseases in offspring from other pregnancies," McAllister added. Secondly, it could lead to biomarkers for identifying pregnancies at higher risk from infections and taking steps to protect mothers by vaccination or treatment.

That will likely involve further work in mice followed up with experiments in nonhuman primates before moving into human studies. (ANI)

More:
Study analyses risks of maternal infections, neurodevelopmental disorders in offspring - Devdiscourse

Recommendation and review posted by Bethany Smith

On the morning of Dec. 20, 2019, the Chinese fish monger Chen Qingbo was cleaning out his stand at the market, completely unaware that he would soon become the focus of intense scientific research, that he was carrying a virus within him of a kind the world had never seen before. He was unaware that his fate was linked closely with that of all of humanity.

He had been up since 5 a.m. and had already made deliveries to his primary customers, including a number of hotels and restaurants in the Chinese metropolis of Wuhan. The Huanan retail and wholesale market, located not far from the train station, had been his base of operations for the last 10 years. By around 11 a.m., he had finished his work for the day and climbed into his Chevrolet for the short drive from the market to his home.

Chen is a sturdily built 42-year-old with a buzz cut and round glasses, married with two children. His small company employs three workers and he owns two delivery trucks, an apartment in Wuhan and two other apartments in his home province of Fujian. He works every day of the week, including weekends. "But on that Friday," he says, "I felt strangely tired and despondent."

Indeed, he was feeling so poorly that afternoon that he dropped by a doctor's office in his neighborhood and he received an infusion, not an uncommon treatment in China. He then went back to work on Saturday and again on Sunday and Monday, but he was feeling worse by the day, with the doctor suspecting a viral infection. Then, on Tuesday, Chen could no longer make it to the market: He had developed a fever and a cough. On Thursday, he checked into the Central Hospital of Wuhan.

Just four days later, Chen was fighting for his life. From the sample that doctors took from his lungs, a laboratory in Shanghai ultimately managed to sequence for the very first time the complete genome of an unknown virus: SARS-CoV-2, the cause of the pandemic that would ultimately spread across the entire world.

On that Dec. 20 in Wuhan, the day that Chen began feeling ill, there was nothing to indicate that a catastrophe was on the horizon. Like all cities in China, Wuhan was preparing for the Chinese New Year's festival at the end of January, an atmosphere comparable to that in Europe ahead of the Christmas holidays - days of pleasant anticipation combined with hectic preparations. Companies were planning parties while workers and students were buying train tickets back home. Communist Party officials also had plenty to do: In early January, city and provincial parliaments were scheduled to meet, an annual ritual.

Wuhan is a vast metropolis, with a population larger than that of cities like New York, London and Paris. It is a place where important rail lines and shipping routes meet, a wealthy, modern city on the banks of the Yangtze River with an impressive skyline and an historical town center built in the European colonial style. The city's politicians and business leaders have long hoped to see Wuhan on a par with other huge Yangtze megalopolises like Shanghai, Nanjing and Chongqing.

Instead, the name Wuhan has become synonymous the world over with a pandemic. That day in December 2019, it became the birthplace of a crisis that can only be compared with the terror attacks of Sept. 11, 2001. And with the 2008 financial crisis, the consequences of which have already been overshadowed by what we are experiencing today.

The novel coronavirus has thus far killed more than 260,000 people officially and has plunged the global economy into an historical recession. It has changed the day-to-day lives of people around the world, fundamentally altered citizens' relationship with the state and reshaped geopolitics.

The article you are reading originally appeared in German in issue 20/2020 (May 09, 2020) of DER SPIEGEL.

The political and economic consequences of the coronavirus are so significant that the entire world order may ultimately be transfigured. It may slow globalization, or it may accelerate it. It could catapult the world out of the industrial age into a new era. The only thing that is certain is that change is coming.

More than four months after fish monger Chen became one of the very first people to come down with the respiratory illness later named COVID-19, there are a number of theories and opinions in circulation about the origins and spread of the illness. DER SPIEGEL has reconstructed events in Wuhan in an effort to learn how the outbreak could have happened and what took place in the early days in the city's hospitals and health agencies. And to learn whether the global pandemic could have been prevented if officials, doctors and politicians had behaved differently. In short, to learn who might share the blame for this pandemic.

This reconstruction is based on numerous discussions and meetings, on reporting in Wuhan itself but also on reporting by Chinese journalists. A complete picture can only be provided by an in-depth international investigation of the kind being demanded by experts and politicians around the world - an investigation that Beijing has thus far resisted. But it can already be said with certainty that mistakes were made in Wuhan and that the global spread of the disease could, at the very least, have been slowed.

It isn't known when and where the first person became infected with SARS-CoV-2. But it is considered extremely likely that the precursor to the pathogen comes from bats and based on genetic analysis, it is believed that the virus jumped to humans only one single time, at some point in fall 2019.

A traditional market in Wuhan: The virus only jumped to a human on one single occasion.

That is rather unusual. It is generally the case that a longer process of genetic adaptation is necessary before a virus that originates in animals can be passed from human to human. Generally, humans repeatedly become infected by animals before a pathogen mutates such that it can be passed from person to person. But SARS-CoV-2 followed a different path. Researchers believe that a specific genetic sequence is responsible, one that joined the genome that produced SARS-CoV-2 predecessor completely by chance. It is that sequence that has made it so easy for the virus to spread.

Researchers have two hypotheses for the beginning of the pandemic: Either this genetic sequence was added to the virus when it was still reproducing in its animal host - whether it be bats, pangolins or raccoon dogs so that the first person who became infected was immediately able to pass it along. Or a precursor was circulating unnoticed for months, but wasn't particularly contagious before the new sequence was added.

Either way, close contact between humans and animals provide ideal conditions for viruses to jump to humans. And those conditions were present at a wildlife market in Wuhan.

On Dec. 26, the day when the fish monger Chen Qingbo checked into the Central Hospital of Wuhan, the pulmonologist Zhang Jixian, 54, had her first encounter with the virus at a different clinic in Wuhan. An elderly patient was suffering from a fever, a cough and breathing difficulties and tests for influenza and other, similar illnesses had all come back negative. Dr. Zhang ordered a CT scan of the patient's lungs and found that she was suffering from a severe and unusual form of pneumonia.

One day later, the neurological department asked Zhang for assistance with an elderly patient experiencing similar symptoms. His CT scan had also revealed severe pneumonia. The doctors soon figured out that the male patient and the female patient were married. "I felt something was wrong," Zhang would later tell the state-run news agency Xinhua.

The doctor learned that the son of the two patients had brought them to the hospital and she convinced him to submit to a CT scan of his own lungs. "He resisted initially," according to Zhang. "He had no symptoms and thought we wanted to get him to undergo an expensive procedure."

Once the scan was performed, though, it revealed the same lesions on the lungs that his parents had. For Zhang, it all pointed to a "contagious disease," and after a few more tests, she was convinced. "This was not an ordinary virus." That same day, she reported her findings to the authorities.

People suffering from the same symptoms were showing up at other hospitals in the city as well. Most had one thing in common: Like Chen Qingbo, they had been traders, suppliers or customers of the Huanan market.

Before it was closed down, the market consisted of two large halls separated by a broad road. Each hall contained dozens of stands and Chen's stand was in the eastern part of the market, where primarily fish and shellfish were on offer. In one corner of the larger, western half of the market, there were several stands that offered exotic wares like snake, fox and salamander meat along with scorpions, crocodiles, live hedgehogs (for the equivalent of 4.50 euros per kilogram), living wolf pups (3 euros) and civets (32 euros). Civets are thought to be the transmitter of the SARS coronavirus that began spreading in southern China in 2002.

In such markets, animals are crammed into cages in horrific conditions, and images taken from this part of the market in Wuhan before it was shuttered on Jan. 1 show dismal-looking stands with dire hygienic conditions. Even today, more than four months later, you can still smell the rotten stench if you approach the site, which has been completely cordoned off.

"They allegedly also sold pangolins there," says Chen Qingbo. "But I never saw them. I never went over to those stands. I find wild animals to be dirty and I'm afraid of them." The eastern part of the market, by contrast, was a completely normal Chinese market, says Qingbo. "Even the restrooms were OK. They were cleaned every day."

After he was taken to the Central Hospital, Chen's condition worsened quickly. He was hardly able to stand on his own and his temperature climbed to 39.8 degrees Celsius (103.6 degrees Fahrenheit). He grew panicky when the doctor showed him the CT scan of his lungs. "He told me he had never seen such bad pneumonia. Three quarters of my lungs were completely white in the scan." On Dec. 30, Chen lost consciousness. The doctors took a sample of the fluid in his lungs and told his family that he was in critical condition.

At this point, they had just an initial idea of what kind of virus they could be facing. Several days earlier, the Wuhan Central Hospital had sent a sample from a patient suffering from similar symptoms to Vision Medicals, a genetic laboratory in Guangzhou, and on Dec. 27, the lab had got back to them with the results. "They just called and told us that it was a new type of coronavirus," a head physician from the hospital told the magazine Caixin, adding that he was surprised they hadn't sent a written report.

Because most of those infected with SARS-CoV-2 experience mild symptoms or none at all, scientists now believe that the virus had already spread widely by this point - in Wuhan and likely beyond. Several months later, French doctors went back and tested old samples from patients who had reported flu-like symptoms and found that a man near Paris had become infected with the novel coronavirus as early as Dec. 27.

"I think that the more people look, the more such early cases will be found," says Thomas Briese, a professor of epidemiology at Columbia University Medical Center in New York. A group of British and French scientists did something similar, combing through an online database on the search for tiny differences in genome sequences in thousands of SARS-CoV-2 samples from around the world. In the journal Infection, Genetics and Evolution, they write: "The genomic diversity of the global SARS-CoV-2 population being recapitulated in multiple countries points to extensive worldwide transmission of COVID-19, likely from extremely early on in the pandemic."

"It seems unlikely to me that a global spread could have been prevented," says Grard Krause, head of epidemiology at Germany's Helmholtz Center for Infection Research. Nevertheless, says Torsten Feldt, infectiologist and chief physician at the University Hospital of Dsseldorf, "I am quite certain that many lives would have been saved by an earlier lockdown."

On the afternoon of Dec. 30, Ai Fen, head of emergency services at the Wuhan Central Hospital, received the test results of yet another patient. The test had been performed by a laboratory in Beijing called CapitalBio and the doctor found the results deeply unsettling. The finding: "SARS-coronavirus."

SARS first appeared out of the blue in the early 2000s, an unknown infectious disease with the potential to trigger a pandemic. That illness killed just 774 people before it was then stopped, essentially a warning shot to the world. Was it now back?

"I was so scared I broke out in a cold sweat," Ai later described her reaction on reading the lab report. She informed the clinic leadership, marking the words "SARS-coronavirus" on the report with a red pen, took a photo and sent it along with a patient's CT scan to former medical school classmates and to colleagues in her ward "to remind everybody to be careful."

Ai's message also reached her colleague Li Wenliang, who worked as an ophthalmologist on the third floor of the Central Hospital. At 5:43 p.m., he used WeChat to inform university friends of a presumed SARS outbreak. An hour later, he amended his message due to the apparent preliminary nature of the results from the Beijing laboratory: "It has been confirmed that it is a coronavirus infection, but the precise subtype of the virus is still being evaluated."

As it would turn out, the new pathogen is similar to the SARS coronavirus -- it's not quite as deadly, but it's apparently even more contagious. And the doctors Ai and Li were right to issue warnings, as events would soon show.

On the morning of Dec. 31, officials in white protective suits began disinfecting the Huanan market. Meanwhile, the health agency issued its first public statement on the new illness: In Wuhan, it said, 27 cases of "pneumonia of unknown causes" had appeared. Thus far, the statement continued, there were no confirmed cases of human-to-human transmission.

That last piece of information was reassuring to doctors, researchers and health policy officials around the world. And it seemed perfectly plausible: New viruses generally tend to spread slowly early on.

But despite its plausibility, the information was incorrect. SARS-CoV-2 was an exception. It could be that there were no confirmed cases of human-to-human transmission in late December, but the findings by doctors leave no doubt that such transmissions had long since begun.

Fully 21 days would pass, however, before the Chinese government publicly admitted as much three weeks that contributed immensely to a local epidemic rapidly growing into a worldwide pandemic.

Dr. Ai Fen: "I was so scared, I broke out in a cold sweat."

Shi Zhengli is the most accomplished scientist at the Wuhan Institute of Virology. She was at a conference in Shanghai when she received an urgent phone call from Wuhan telling her to drop everything she was doing. Samples had arrived, she was told, from seven patients exhibiting SARS-like symptoms.

Shi is an internationally recognized virologist who has been nicknamed "Bat Woman" by her colleagues for the virus research she has performed on the animals. She was the one who first identified the viruses that SARS derived from and she has published numerous papers in well-respected journals. In the PubMed database, she is listed with 66 papers published about coronaviruses.

Her team spent the next several days feverishly sequencing the genetic code of the new virus, but Shi herself concentrated on trying to find out whether the new virus matched one of the viral strains on which her institute had been conducting research in recent years. She was initially concerned that an accident may have occurred and a sample may have escaped her laboratory.

The Wuhan Institute of Virology, where she works, is a sprawling complex surrounded by a high electric fence in the southern part of the city. Five years ago, it became the first research site in China with the highest biosafety level BSL-4.

But it wasn't the only state laboratory where Chinese researchers were working hard to sequence the virus. Lan Ke, director of the State Key Laboratory of Virology at Wuhan University, received samples on Jan. 2 containing lung secretions from two patients from Zhongnan Hospital for analysis. "Honestly, my first though was that it could be a new pathogen to be identified," he told DER SPIEGEL. "But we were not sure if it was SARS." By Jan. 3, he and his team had detected the first RNA fragment of the pathogen. They then decoded the sequence and compared it with known viruses using an online database. They found no matches. The scientists furthermore recognized that the pathogen was less similar to SARS than it was to bat-born coronaviruses.

On Jan. 11, the Shanghai Public Health Clinical Center became the first to publish the genome sequence of the pathogen, doing so on the research website virological.org. The sequence came from a sample taken from the fish monger Chen Qingbo.

The next day, the center was temporarily closed down by Chinese authorities. No reason was given for the move.

On Dec. 31, Chen Qingbo was transferred from the Central Hospital of Wuhan to the Jinyintan Hospital, the first of the city's large hospitals to be dedicated specifically to treating patients suffering from the novel coronavirus. The fish seller initially ended up in the intensive care ward, but he was unaware of what was happening to him. He also still didn't know - though it is likely whether he was among the 41 patients chosen by specialists in the hospital to be part of a study that would be published three weeks later in the respected medical journal The Lancet. Even today, it remains one of the most important clinical studies on the early phase of the crisis.

Once his condition began improving and he was transferred to a different ward, Chen started receiving visits from "people from health services or some provincial agency." He says they would show him their IDs and ask him questions. "I don't know anymore who they were or what they wanted," he says. "I could only see their eyes behind thick protective goggles."

Chen has precise memories, though, of the mayor of Wuhan visiting his ward on Jan. 6. "After he left, the nurses told us that the government would be paying for our treatment from then on. And shortly thereafter, all of our costs were reimbursed."

On Jan. 3, Wuhan health officials reported 44 patients with unidentified viral lung infections, including 11 serious cases such as the one experienced by Chen Qingbo. But the number did not reflect the true expanse of the crisis. Many increasingly frustrated doctors were having difficulties reporting the number of new infections to the authorities.

Patients waiting to be transfered to another hospital in Wuhan: The city also provided the blueprint for combating the pandemic.

That system for reporting infections is the key element in what are actually strict regulations in China designed to track outbreaks of contagious diseases. The system was introduced following the SARS crisis and requires clinics to report suspicious cases to the government in Beijing without delay. The system is "quite simple," a doctor told the magazine Caixin. "Prior to corona, when we discovered a case of hepatitis B or another serious infectious disease, we were able to enter our diagnoses directly. A report card would open up, which we would fill out and then click "OK" to upload it."

It was this system that provided Beijing with a timely warning in 2013 of the bird flu outbreak and, in November 2019, of two pneumonic plague cases in Inner Mongolia. But in Wuhan, it suddenly stopped working. The authorities began demanding that hospitals first clarify each new case with the local authorities before they were allowed to upload them into the national reporting system.

In early January, scientists at several genetic laboratories received calls from provincial health authorities from the province of Hubei. They were asked to stop work on the analyses they were currently performing and to destroy their samples. They were then told: "If you perform tests in the future, be sure to report to us," one of the scientists later told Caixin.

As early as Dec. 29, the Central Hospital of Wuhan had sent four reports of corona cases to the local health office for appraisal. The head of the office promised to report back soon, adding that similar case reports had been received from other clinics. Two days later, the doctors asked about the results, but were told to be patient. On Jan. 3, they asked if they should post the case reports - seven of them by then to the national reporting system. They were asked to wait.

The most important political events of the year, after all, were imminent. On Jan. 6, a session of the city parliament was set to begin, and the Peoples Congress for the Hubei province was to convene on Jan. 11. And it was now that the provincial government also issued an order that entries into the national disease tracking system be made "cautiously. Entries were to be coordinated not just with the local health authorities, but also with the city and provincial governments.

The authorities were doing all they could to keep both the public and the central government in the dark about the true extent of the epidemic likely to prevent the disruption of the two parliamentary sessions. It could, however, also have been because they simply didn't want to spread bad news especially not to Beijing.

The loudest voices, the doctors Ai Fen and Li Wenliang, had already been silenced by then. On Jan. 2, Ai was given an "unprecedented, extremely harsh reprimand, as she would later say in a magazine interview. Then, on Jan. 3, the police interrogated Li and he was forced to pledge in writing that he would cease spreading "rumors. He returned to the hospital and contracted the virus himself on Jan. 8.

But even as the authorities sought to downplay the crisis, an increasing number of people infected with the virus began turning up at Wuhan hospitals. The citys health authority reported only 59 cases on Jan. 5, and on Jan. 11, it even spoke of "41 initially diagnosed cases. It claimed that there had been "no new cases since Jan. 3. Against all evidence, the authority also stated that there was no indication that the pathogen, which was now being referred to as the "novel coronavirus, was transmissible from human to human.

But the bad news reached Beijing, anyway, despite the lies from the local authorities. Virologist Gao Fu, the head of Chinas Center for Disease Control and Prevention, has made a habit of scanning China's internet before bedtime for indications of possible disease outbreaks. On Dec. 30, Gao came across rumors about an internal memo from the Wuhan Health Commission on the outbreak of an undefined lung disease. He called an official at the authority and was exasperated by the evasive answers he was given.

The next morning, Gao sent the first of three teams of experts to Wuhan. The Beijing office of the World Health Organization was also officially informed that same day. Shortly afterward, Gao spoke by phone with Robert Redfield, the director of the Centers for Disease Control in the United States, who was on vacation at the time. Redfield was deeply disturbed about what Gao had to report. According to a report in the New York Times, Gao even broke into tears during a later conversation with Redfield.

Meanwhile, officials in Wuhan continued to play down the situation to their colleagues in Beijing. "They said the course of the disease was mild, not much different from seasonal flu, says a member of the second Beijing delegation, which would arrive in Wuhan about a week later.

The local authorities even issued an order that the only patients that should be counted were those who had themselves been to the Huanan market or had a connection with a visitor to the market. As a result of that order, the growing number of infections simply vanished from the statistics. An increasing number of infections, after all, had no connection with the market whatsoever.

Still, even though Beijing was now aware of the situation, official reporting did not change.

The city of Wuhan on Feb. 3: The largest quarantine ever imposed in the history of humankind.

And the Wuhan health authority continued to lie: On Jan. 11, it reported that there hadn't been a single known case among medical staff. In chatrooms, though, the opposite claim was spreading, something that epidemiologist Li Lanjuan learned on Jan. 17. Alarmed, she reported to the National Health Commission and requested permission to drive to Wuhan immediately. Officials in Beijing agreed. On Jan. 18, Li left for the city together with five other epidemiologists. It was only after this visit by the third Beijing delegation that the world would find out what was happening in Wuhan.

The team visited several hospitals, the Huanan market and the Center for Disease Control located only 300 meters away. The experts no longer had any doubts about human-to-human transmission of the virus or that medical personnel had themselves become infected. In a confidential meeting, Li urged that the highest disease alert level - normally reserved for plague or cholera outbreaks be declared. She proposed sealing off the city of Wuhan. There were only a few days left until the peak of the New Year travel season, and the concern was that the disease could spread throughout the country.

The experts flew back to Beijing on Jan. 19 armed with these recommendations. At around midnight, they were received by the Chinese health minister, and the next morning, they attended a cabinet meeting in Zhongnanhai, the innermost circle of power in the Chinese leadership. They issued their warnings at the meeting.

It was then, on Monday, Jan. 20, that the Chinese and the rest of the world would learn of the shocking news from Chinese media. Three days later, in the early morning hours of Jan. 23, Beijing moved to seal Wuhan off from the outside world. In the following days, the lockdown would be extended to include the entire Hubei province. Around 60 million people were ordered to shelter in place in their homes in the largest quarantine ever imposed in the history of humankind.

On the morning of Jan. 23, Wuhan was smothered in a thick layer of smog, with particulate matter levels at six times the legal limit. But there were very few cars on the streets and the few people who did attempt to leave the city were turned back. A convoy of police buses arrived at the airport and by 10 a.m., it was no longer possible to leave the city by air either.

There were also long lines of people in front of hospitals, while emergency rooms had become places of panic and desperation. Ai Fen reported that more than 1,500 patients were now crowding into her department each day, "three times the usual maximum. More than 200 of the 4,000 employees at the Wuhan Central Hospital got infected with the virus at the peak of the epidemic.

Ophthalmologist Li Wenliang was so ill by the end of January that he had to be transferred to the intensive care unit and intubated. On Jan. 27, he defied the official ban on speaking to the press and gave an interview to the state-run Beijing Youth Daily using a messaging app. He could no longer speak. On Feb. 5 and 6, his condition deteriorated further and he had to be placed on life support. The hospital reported on his treatment using the microblogging platform Weibo. Some 17 million users followed the increasingly hopeless developments late into the night.

Shortly before 3 a.m., the doctors lost the battle to save their colleagues life. It unleashed an overwhelming wave of sympathy, with 870,000 users expressing their anger and grief on the internet, leading the state to ultimately abandon its censorship efforts. Li, 33, who left behind a son and a pregnant wife, embodied the center of Chinese society, precisely that segment on which the party bases its rule: the young, hard-working and well-educated. Like many doctors, he had been a member of the Communist Party.

The death of Li Wenliang, who had seen the danger coming, had warned his friends and colleagues and was punished for his efforts, shook many young Chinese so deeply that for a few days it appeared as though the party might lose its hold on society. In some ways, it was evocative of 31 years before, when the death of Hu Yaobang, a politician also revered by many young Chinese and humiliated by the party, triggered the protests in Tiananmen Square.

This time, though, there were no protests. Mourners laid flowers and candles in front of the Central Hospital. The party hastened to announce that it had expressed its condolences to Lis family and it initiated an investigation on the day of his death into the events surrounding his interrogation. A few days later, the government declared Li and 13 other doctors who had died of COVID-19 as "martyrs.

By now, the state and the party were now moving to mobilize all available resources. In the northwest and far south of the city of Wuhan, the Peoples Liberation Army set about constructing two emergency hospitals with more than 2,500 beds, finishing the job within two weeks. Stadiums and convention centers were also converted into makeshift hospitals, and within days, block after block of apartment buildings had been cordoned off, with party members standing guard to make sure people didnt leave their homes.

Virologist Gao Fu: Exasperated by the evasive answers he was given.

The world watched in a daze as Chinas leaders submitted millions of people to its quarantine regime. DER SPIEGEL and other Western media wrote that a lockdown that strict was "unthinkable in a democratic society. At that point, few had any idea that the events in Wuhan were providing a glimpse into their own future - and that only a few weeks later, a significant segment of the global population would find itself stuck in a similar situation. Far from just being the breeding ground for the virus, Wuhan also provided a blueprint for fighting the epidemic.

Eleven weeks after the lockdown was imposed on Wuhan, Wang Xinghuan, the director of one of the largest hospitals in the city, was standing outside his clinic in a tracksuit and speaking of the lessons he had learned from the crisis. "Three things are essential," he said, "rigorous testing, the immediate isolation of suspected cases and the wearing of masks." He said that he was in regular contact with colleagues in New York and that one of them had told him that the wearing of masks was unfortunately a cultural issue. "But it isn't a cultural issue," Wang insisted. "It's stupid to not wear a mask."

In March, an international team of epidemiologists calculated that the number of infections would have been three-times, seven-times or 18-times higher respectively if China had imposed the lockdown on Wuhan one, two or three weeks later than it did. It is difficult to imagine how many cases and deaths there might be in the world today had the country waited.

But the same study estimates that the numbers would have been 66 percent, 86 percent or 95 percent lower respectively had the government closed off the city one, two or three weeks earlier than it did.

Depending on one's perspective, then, Beijing is to be commended for protecting the world from a much greater catastrophe - or is to be condemned for triggering the disaster we are currently experiencing in the first place.

In February, the regime began pushing the first of the two narratives. Chinese President Xi Jinping has even claimed that he personally issued "specifications for the prevention and control of the novel coronavirus" way back on Jan. 7 in a speech before the Politburo Standing Committee. The text of that speech has not been released to the public, but anonymous sources have said that Xi merely decreed that the measures should not detract from the "festive atmosphere" ahead of the Chinese New Year.

The question regarding when Xi learned of the new virus is crucial when it comes to assigning responsibility. There are a number of indications that Beijing was misled by the provincial government and that the central government only recognized the severity of the epidemic in mid-January. But if Xi really was aware of the problem on Jan. 7, then he would have to bear responsibility for the fact that the world was deceived for so long regarding the true nature of the disease.

Wuhan's new top Communist Party official - his predecessor was fired in February proposed in early March that the people of the city undergo "gratitude education." The party went on to publish a book called "2020: A Battle Against the Epidemic," which honors Xi's alleged accomplishments in the "people's war" against the virus. Following a wave of indignation in the Chinese internet, though, the campaign was soon suspended.

The government, however, can now point to foreign sources to prop up its version of events. WHO head Tedros Adhanom Ghebreyesus said he had been "impressed and encouraged by the president's detailed knowledge of the outbreak" following a visit he made to Beijing in late January. Quotes such as this one are quite helpful to Beijing, both for its domestic propaganda and for its international PR campaign, which seems to be growing in strength by the week.

In this battle over the coronavirus narrative, Chinese diplomats eagerly cite statements and tweets from U.S. President Donald Trump. Quotes like this tweet from Jan. 24: "China has been working very hard to contain the Coronavirus. () I want to thank President Xi!" Or this remark from Feb. 7: "I just spoke to President Xi last night. () I think he's handled it really well."

In the meantime, of course, Trump has begun disputing the numbers that he was praising just 10 weeks ago and is now accusing China of lying and he's not the only one. He has also begun claiming that he has intelligence information whereby the virus actually escaped from a Chinese laboratory, a reference to the Wuhan Institute of Virology in the southern part of the city the lab where "Bat Woman" Shi Zhengli works.

People pay respect at a memorial to Dr. Li Wenliang: "There should be more than one voice in a healthy society."

In February, Shi told the U.S. magazine Scientific American that she worked day and night at the beginning of the epidemic comparing all the samples the institute had ever used for research with the genome sequence of SARS-CoV-2 - and found no matches. "That really took a load off my mind," she told the magazine. She believes her lab bears no responsibility for the outbreak.

In mid-April, only a few cars could be seen on the other side of the electric fence in the parking lot of the Wuhan Institute of Virology. Visitors are not welcome. A car drove up and a young man in street clothes introduced himself as Mr. Zhao from "Bio Security." He demanded to know what the reporter was looking for. An interview with Dr. Shi, perhaps? "Impossible," was the response. But wouldn't it be helpful to respond to the rumors that are spreading around the world? Mr. Zhao smiled. "It doesn't matter what we say. These theories will spread regardless."

Some of those theories are rather preposterous. Nobel prize laureate Luc Montagnier, who was one of the scientists to discover the virus that causes AIDS, claimed on French television that SARS-CoV-2 was produced in the lab and contains genome sequences from the HIV virus. Researchers were quick to contradict him: "Montagnier failed to find that both fragments are actually also commonly found in many other viruses, including coronaviruses from bats and pigeons," the team of Yang Zhang, professor of computational medicine and bioinformatics at the University of Michigan, told DER SPIEGEL.

The most likely scenario is that the two genome fragments ended up in SARS-CoV-2 as the result of a completely natural process. That, at least, is what the vast majority of leading virologists believe.

It is, of course, possible that an employee of the Wuhan Institute of Virology may have become infected with an unknown, natural bat virus despite wearing protective clothing, but it is "extraordinarily unlikely," says Robert Garry of the Tulane University School of Medicine.

U.S. intelligence likewise issued a statement saying that the broad consensus is that the virus is not manmade. China has thus far refused to permit an international investigation into the origins of the virus. But without such a study, rumors will continue to spread regarding the beginning and development of the disease.

A particularly absurd conspiracy, which ironically originated in the U.S., has been spreading in Wuhan itself. The fish seller Chen Qingbo says that "many of my friends believe, as do I, that the virus was brought to Wuhan during the Military World Games last fall. The U.S. athletes apparently stayed in a hotel not far from the Huanan market and some of them allegedly were suffering from a similar illness." He then asks: "Couldn't that be true?"

Following his recovery, Chen was released from the hospital on Jan. 11, well before the epidemic reached its peak. After finishing his quarantine, he received a text message from the hospital's chief physician: "Recovered patients are kindly requested to donate blood plasma for scientific purposes." Chen responded immediately and has been to the hospital five times since then. He has resumed working, but he now supplies fruit and vegetables instead of fish. And he now works out of a different market.

Ai Fen is still the head of emergency services at the Central Hospital of Wuhan. On March 10, she gave a long interview to China's state-run People magazine in which she said: "I regret that back then I didn't keep screaming out at the top of my voice. I've often thought to myself what would have happened if I could wind back time."

Read the original here:
A Failed Deception: The Early Days of the Coronavirus Outbreak in Wuhan - DER SPIEGEL

Recommendation and review posted by Bethany Smith

The global Androgen Replacement Therapy Market research report thoroughly explains each and every aspect related to the Androgen Replacement Therapy Market, which facilitates the reports reader to study and evaluate the upcoming market trend and execute the analytical data to promote the business. The growth trend forecasted on account of thorough examination offers in-depth information regarding the global Androgen Replacement Therapy Market. A pathway of development is offered by the market to the several connected networks of businesses under it, which include different firms, industries, organizations, vendors, distributors, and local manufacturers too. All the key Androgen Replacement Therapy Market players compete with each other by offering better products and services at a reasonable price in order to grab significant share at the regional and global level market.

Androgen replacement therapy (ART), often referred to as testosterone replacement therapy (TRT), is a form of hormone therapy, in which androgens, often testosterone, are replaced. ART is often prescribed to counter the effects of male hypogonadism. It typically involves the administration of testosterone through injections, skin creams, patches, gels, or subcutaneous pellets. Testosterone replacement therapy is a promising technology for improving symptoms of hypogonadism and to raise the testosterone level. Furthermore, benefits related to application of testosterone replacement therapy include an increase in muscle tissue, overall surge in energy, and significant decrease in depression symptoms.

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This report sample includesBrief Introduction to the research report.Table of Contents (Scope covered as a part of the study)Top players in the marketResearch framework (presentation)Research methodology adopted by Coherent Market Insights

The report incorporates an estimated impact of strict standards and regulations set by the government over the market in the upcoming years. The market report also comprises exhaustive research done using several analytical tools such as SWOT analysis to identify the market growth pattern.

Top Manufacturers in GlobalAndrogen Replacement TherapyMarket Includes:AbbVie, Inc., Allergan Plc, Bayer AG, Endo Pharmaceuticals, Inc., Eli Lilly and Company, Kyowa Kirin International Plc, Mylan N.V., Novartis International AG, Pfizer, Inc., Clarus Therapeutics, Ferring Holding SA, Perrigo Company Plc, Acerus Pharmaceuticals Corporation, Upsher-Smith Laboratories, LLC, Dr. Reddys Laboratories, Bausch Health Companies Inc., Sun Pharmaceutical Industries Ltd., and Par Pharmaceutical.

Regions & Countries Mentioned In The Androgen Replacement Therapy Market Report:

Key Highlights of the Table of Contents:

Androgen Replacement Therapy Market Study Coverage: It includes key manufacturers covered, key market segments, the scope of products offered in the global market, years considered, and study objectives. Furthermore, it tuches the segmentation study provided in the report on the basis of the type of product and applications.

Androgen Replacement Therapy Market Executive Summary: This section emphasizes on the key studies, market growth rate,Competitive landscape, market drivers, trends, and issues.

Androgen Replacement Therapy Market Production by Region: The report provides information related to import and export, production, revenue, and key players of all regional markets studied are covered in this section.

Androgen Replacement Therapy Market Profile of Manufacturers: Analysis of each market player profiled is detailed in this section. This also provides SWOT analysis, products, production, value, capacity, and other vital factors of the individual player.

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Table of Contents

Report Overview:It includes the Androgen Replacement Therapy market study scope, players covered, key market segments, market analysis by application, market analysis by type, and other chapters that give an overview of the research study.

Executive Summary:This section of the report gives information about Androgen Replacement Therapy market trends and shares, market size analysis by region and analysis of global market size. Under market size analysis by region, analysis of market share and growth rate by region is provided.

Profiles of International Players:Here, key players of the Androgen Replacement Therapy market are studied on the basis of gross margin, price, revenue, corporate sales, and production. This section gives a business overview of the players and shares their important company details.

Regional Study:All of the regions and countries analyzed in the Androgen Replacement Therapy market report is studied on the basis of market size by application, the market size by product, key players, and market forecast.

An Overview of the Impact of COVID-19 on this Market:

The pandemic of COVID-19 continues to expand and impact over 175 countries and territories. Although the outbreak appears to have slowed in China, COVID-19 has impacted globally. The pandemic could affect three main aspects of the global economy: production, supply chain, and firms and financial markets. National governments have announced largely uncoordinated, country-specific responses to the virus. As authorities encourage social distancing and consumers stay indoors, several businesses are hit. However, coherent, coordinated, and credible policy responses are expected to offer the best chance at limiting the economic fallout.

National governments and international bodies are focused on adopting collaborative efforts to encourage financial institutions to meet the financial needs of customers and members affected by the coronavirus. However, there are some sectors that have remained unscathed from the impact of the pandemic and there are some that are hit the hardest.

We, at Coherent Market Insights, understand the economic impact on various sectors and markets. Using our holistic market research methodology, we are focused on aiding your business sustain and grow during COVID-19 pandemics. With deep expertise across various industries-no matter how large or small- and with a team of highly experienced and dedicated analysts, Coherent Market Insights will offer you an impact analysis of coronavirus outbreak across industries to help you prepare for the future.

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Androgen Replacement Therapy Market 2020 Coronavirus (Covid-19) Business Impact Future Forecast Assessed On The Basis Of How The Market Is Predicted...

Recommendation and review posted by Bethany Smith

(PRESS RELEASE) CHICAGO In order to help patients with Inherited Retinal Diseases (IRDs) receive an accurate diagnosis through genetic testing, Prevent Blindness, the nations oldest volunteer eye health organization, is embarking on a new awareness initiative to educate the public on IRDs, a group of genetic disorders that can cause severe vision loss or total blindness. A recent editorial noted that IRDs are the leading cause of vision loss in persons between 15 and 45 years of age- impacting one in every 2,000 people.

To continue the Prevent Blindness mission of preventing blindness and saving sight, the group has declared May 17-23, 2020 as Inherited Retinal Disease Genetic Testing Week. As part of this initiative, Prevent Blindness has created a dedicated webpage (to go live on May 15, 2020) with no-cost educational resources on IRDs, providing detailed information on risk factors, therapy and research options, financial assistance services, the importance of genetic testing, and more. Shareable social media graphics on IRDs are also available. Development of these new resources was supported by a donation from Spark Therapeutics, a gene therapy company striving to challenge the inevitability of genetic disease.

The most common types of IRDs include:

All those diagnosed with IRDs should work with their healthcare professional to develop a disease management plan tailored to the patients needs.

Patients with suspected IRDs are encouraged to participate in genetic testing, even those who were tested more than five years ago and did not receive a definitive result. According to the National Institutes of Health, genetic testing is a type of medical test that identifies changes in chromosomes, genes, or proteins. The results of a genetic test may provide a detailed diagnosis which confirms or rules out most suspected genetic conditions and the test can help determine a persons chance of developing or passing on a genetic disorder to their children. Free genetic testing is now available from select organizations and commercial businesses, including through the ID YOUR IRD program.

Inherited retinal diseases can have a significant impact on the quality of life for patients, including affecting the ability to work and live independently, said Jeff Todd, president and CEO of Prevent Blindness. Fortunately, today there are more therapies being researched than ever before. We encourage patients and their caregivers to educate themselves on steps that can be taken today to save sight for tomorrow.

As a leading gene therapy company with a strong commitment to genetic testing for the IRD community, Spark Therapeutics is pleased to support the Prevent Blindness inaugural IRD Genetic Testing Week, said Dan Chung, DO, MA, ophthalmology therapeutic area leader, Spark Therapeutics. We encourage patients living with IRDs and caregivers to pursue genetic testing in order to receive a true, genetic diagnosis.

For more information on IRDs and genetic testing for vision issues, please call Prevent Blindness at (800) 331-2020 or visit here. For a listing of vision care financial assistance programs in English or Spanish, visit here.

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Prevent Blindness Offers New Educational Resources on IRD's, Importance of Genetic Testing and Services - InvisionMag

Recommendation and review posted by Bethany Smith

The Covid-19 (coronavirus) pandemic is impacting society and the overall economy across the world. The impact of this pandemic is growing day by day as well as affecting the supply chain. The COVID-19 crisis is creating uncertainty in the stock market, massive slowing of supply chain, falling business confidence, and increasing panic among the customer segments. The overall effect of the pandemic is impacting the production process of several industries including Life science Industry, and many more. Trade barriers are further restraining the demand- supply outlook. As government of different regions have already announced total lockdown and temporarily shutdown of industries, the overall production process being adversely affected; thus, hinder the overall Genetic Testing Service market globally. This report on Genetic Testing Service market provides the analysis on impact on Covid-19 on various business segments and country markets. The report also showcase market trends and forecast to 2027, factoring the impact of Covid -19 Situation.

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The Genetic Testing Service market was valued at US$ 9,546.2 million in 2019 and is expected to grow at a CAGR of 11.7% from 2020 to 2027 to reach US$22,701.8million by 2027.

Market Insights

Government initiatives to increase awareness in the European Region

In Europe, Genetic testing has been growing at an exceptional rate; a large panel of tests are now offered to screen a number of genetic diseases. Treatments are available for a number of rare genetic diseases, and the process is gaining importance in scenarios, such as carrier testing, newborn screening, predictive, and pre-symptomatic testing, among others. Moreover, European countries have undertaken a number of initiatives to increase awareness among people about the benefits of genetic testing. For instance, EuroGentest is a project funded by the European Commission to harmonize the process of genetic testing, from sampling to counseling, across Europe. The ultimate goal is to ensure that all aspects of genetic testing are of high quality, thereby providing accurate and reliable results for the benefit of the patients. In addition, the UK Genetic Testing Network (UKGTN), an advisory organization in UK, promotes equity of access to genetic testing and provides contracting support to the NHS

Type Insights

The global genetic testing service market, based on the type, has been segmented into predictive testing, carrier testing, prenatal testing, newborn screening and others. In 2019, the predictive testing segment accounted for the largest market share in the global genetic testing service market by disease. Genetic Testing Services consist of large panel of tests are now offered to screen a number of genetic diseases. Treatments are available for a number of rare genetic diseases, and the process is gaining importance in scenarios, such as carrier testing, newborn screening, predictive, and pre-symptomatic testing, among others.

Key Players

The research provides answers to the following key questions:

The study conducts SWOT analysis to evaluate strengths and weaknesses of the key players in the Genetic Testing Services market. Further, the report conducts an intricate examination of drivers and restraints operating in the market. The report also evaluates the trends observed in the parent market, along with the macro-economic indicators, prevailing factors, and market appeal according to different segments. The report also predicts the influence of different industry aspects on the Genetic Testing Services market segments and regions.

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Genetic Testing Services Market Segmented by Region/Country: North America, Europe, Asia Pacific, Middle East & Africa, and Central & South America

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Excerpt from:
COVID-19 Impact on GENETIC TESTING SERVICES MARKET INSIGHT ON THE ANALYSIS BY ESSENTIAL FACTORS AND TRENDS IN INDUSTRY BY 2027 - Cole of Duty

Recommendation and review posted by Bethany Smith

Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Genetic TestingMarket which would mention How the Covid-19 is Affecting the Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Key Regions and Proposal for Genetic Testing Market Players to battle Covid-19 Impact.

The Genetic TestingMarket report is one of the most comprehensive and important data about business strategies, qualitative and quantitative analysis of Global Market. It offers detailed research and analysis of key aspects of the Genetic Testing market. The market analysts authoring this report have provided in-depth information on leading growth drivers, restraints, challenges, trends, and opportunities to offer a complete analysis of the Genetic Testing market.

Top Leading players covered in the Genetic Testing market report: GeneDx, Invitae, Pathway Genomics, Counsyl Inc, Asper Biotech, GenePlanet, Courtagen Life Sciences, Gene By Gene, Natera Inc, Regulatory, GeneTests, United Gene, HI Gene, Berry Genomics, 23andMe Inc, 360Jiyin, Novogene, CapitalBio, Agen, Biomedlab, Biomarker, Annoroad, Aiyin Gene, Aijiyin, Repconex, Find Bio-Tech, SinoGenoMax, Gene Kang, Geeppine, BGI and More

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The report offers clear guidelines for players to cement a position of strength in the global Genetic Testing market. It prepares them to face future challenges and take advantage of lucrative opportunities by providing a broad analysis of market conditions. the global Genetic Testing market will showcase a steadyCAGR in the forecast year 2020 to 2025.

Based on products type, the report describes major products type share of regional market. Products mentioned as follows:Newborn ScreeningDiagnostic TestingCarrier TestingPreimplantation Genetic DiagnosisPrenatal DiagnosisPredictive and Presymptomatic TestingPharmacogenomicsBased on Application, the report describes major application share of regional market. Application mentioned as follows:CardiologyDermatologyHematologyHereditary CancerImmunologyMetabolic Disorders and Newborn ScreeningNeurologyOphthalmologyPediatric GeneticsOthers

Our Complimentary Sample Genetic Testing market Report Accommodate a Brief Introduction of the research report, TOC, List of Tables and Figures, Competitive Landscape and Geographic Segmentation, Innovation and Future Developments Based on Research Methodology.

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Regions Covered in the Global Genetic Testing Market: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

Years Considered to Estimate the Genetic Testing Market Size:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year: 2020-2025

Highlights of the Report: Accurate market size and CAGR forecasts for the period 2019-2025 Identification and in-depth assessment of growth opportunities in key segments and regions Detailed company profiling of top players of the global Genetic Testing market Exhaustive research on innovation and other trends of the global Genetic Testing market Reliable industry value chain and supply chain analysis Comprehensive analysis of important growth drivers, restraints, challenges, and growth prospects

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Genetic Testing Market Report 2020: Acute Analysis of Global Demand and Supply 2025 with Major Key Player: GeneDx, Invitae, Pathway Genomics, Counsyl...

Recommendation and review posted by Bethany Smith

SHANGHAI, China, May 10, 2020 (GLOBE NEWSWIRE) -- Burning Rock and Illumina (NASDAQ: ILMN), a global leader in gene sequencing and array-based technologies, jointly announced today that they are joining forces to promote the development and standardization of NGS-based cancer therapy selection in China based on Illuminas NextSeqTM 550Dx system.

In 2015, Illuminas sequencing technology and Burning Rocks development and commercial capabilities were for the first time combined, providing Chinas precision oncology market with advanced NGS-based cancer therapy selection solutions in the past five years. In 2020, as the first genetic testing company in China to achieve development of in vitro diagnostic (IVD) tests for both circulating tumor DNA (ctDNA) and tissue based on the NextSeqTM 550Dx system agreement with Illumina, Burning Rock will further expand and deepen the application of NGS technologies in the field of cancer therapy selection.

The value of NGS application in precision medicine and companion diagnostics has been widely recognized by clinical experts and cancer patients. Compared with traditional genetic testing methods, NGS-based cancer therapy selection allows patients to understand the mutation of multiple genes related to cancer treatment, providing doctors and patients with one-stop targeted therapy and immunotherapy drugs testing solutions, ultimately saving time and preserving samples.

In July 2018, Burning Rocks innovative product "Human EGFR / ALK / BRAF / KRAS gene mutation detection kit (reversible end termination sequencing method)" based on Illumina sequencing system became the first NGS-based reagent kit to be approved by National Medication Products Administration (NMPA). Since then, tumor NGS testing can be officially used in Chinese hospitals. In the future, Burning Rock will continue to seek NMPA approvals for its IVD products based on NextSeqTM 550Dx and other sequencing systems to promote the implementation of tumor NGS products in hospitals and benefit more cancer patients.

Through our long-term, close and pleasant cooperation with Illumina, we have delivered the world's leading NGS-based therapy selection solutions for clinical oncology, and improved the development and application of NGS-based cancer therapy selection in China. said Mr. Han Yusheng, founder and CEO of Burning Rock. Today we are delighted to announce that Burning Rock and Illumina will further deepen cooperation based on the NextSeqTM 550Dx system, to provide more high-quality molecular diagnostic solutions for clinical oncology treatment and promote the standardization of NGS-based cancer therapy selection in China.

Burning Rock is one of the leading precision oncology companies in China, said Joydeep Goswami, Senior Vice President of Corporate Development and Strategic Planning at Illumina, said. I am pleased to see that during the close cooperation with Illumina in the past five years, Burning Rock has continuously developed tumor diagnosis solutions that meet the needs of the local market. The new agreement is a testament to our strong cooperation in the past, and also the beginning of a more in-depth cooperation.

Li Qing, General Manager of Greater China at Illumina, said: Burning Rock has brought hope to countless Chinese patients by providing a series of tumor molecular diagnostic solutions. And we are very happy to be involved. In the future, I firmly believe that genetic testing technology will further change the current treatment paradigm for cancer and provide critical support to conquer this disease at an early date.

About Burning RockBurning Rock, whose mission is to Guard Life via Science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, with the leading market share in China and over 185,000 tissue and liquid-based tests completed cumulatively, and ii) NGS-based cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.

About IlluminaIllumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture and other emerging segments. To learn more, visit http://www.illumina.com and follow @illumina.

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Burning Rock deepens cooperation with Illumina to promote development and standardization of NGS-based cancer therapy selection in China - BioSpace

Recommendation and review posted by Bethany Smith

A negative drug test for an decades-long opioid patient reveals a genetic abnormality that might be more common than expected.

JACKSONVILLE, Fla. For Linda Armstrong, the pain started 25 years ago with a truck going 45 miles an hour. It left her with severe neurological and brain injuries.

On a scale of one to 10, she said, There are days when its 10. I mean you literally cant move.

Like millions of Americans, she was prescribed opioids -- Vicodin, Dilaudid, Percocet but the pain persisted.

I would get some relief, but nothing that ever really made me functional, she said, "and it always made me nauseous.

Armstrongs lackluster response to pain medications had been a reality since she was a child. Once, getting a cavity filled, she recalls, I had to have 10 shots for one filling because it just would not numb.

Her resistance to drugs was simply anecdotal until she visited her doctor in October. Under new Centers for Disease Control and Prevention guidelines, doctors test opioid patients both for the presence of illegal drugs, and to ensure they are taking and not selling their pain meds.

Her test? Completely negative. There were no drugs of any type in my system.

Initially, her doctor wrote it off as a fluke.

When it happened a second time, Armstrong explained, her doctor said Linda we have to talk about this.

She took another test this time going so far as to take pills while her doctor watched. She even got her hair tested.

Fortunately, Armstrong has had the same doctor since the mid-'90s, and rather than doubting her, she worked to help get answers. She ordered a genetic test, which revealed significant abnormalities -- including in an enzyme called CYP2d6, which metabolizes opioids.

The test revealed something researchers in the field of pharmacogenomics know, but few patients do. People do not respond to drugs in the same way, explains Standford University researcher Dr. Russ Altman in a Ted Talk. Some people get no pain relief at all.

Armstrongs genetic test showed she was a hyper-metabolizer of opioids an issue that creates problems beyond pain. As Altman says, there are only two things a doctor can think when a patient complains they arent getting relief from opioids.

I could think this person is a CYPD2d6 non-responder, or I could think this is a trouble-making drug-seeker who wants something stronger, Altman said. Most doctors think the latter.

Armstrongs case is dramatic but not unusual. Dr Liewei Wang at Mayo Clinic in Rochester, Minn., is a leading researcher in pharmacogenomics research into the interaction of genes and drugs. She says 99 percent of people have at least one genetic variant that affects drug response. Response is variable, and in some cases not desirable.

Genetic testing can predict who may or may not respond, she said, and for those who dont respond -- are there alternative therapies?

In some cases, the wrong drug can be fatal. Already, hospitals like UF Health test cardiac patients before surgery for a gene that complicates blood clotting.

And some fields, like oncology and psychiatry, routinely use genetic tests to prescribe drugs. But most patients arent aware such tests even exist.

Jacksonville Pharmacist Todd Troxell believes genetic testing is the key to more effective prescribing. When you go get your glasses we dont just say, pick something up and go home. We get your prescription, he says. You cant see out of myglasses.

After looking at Armstrongs test, Troxell was able to steer her to a different pain medication that is working. I could tell from what she had on her report she wasnt going to be able to take certain medications.

Troxell would like to see genetic testing more widely available -- and comprehensible. Companies focused on translating dense genetic code into pharmaceutical recommendations were effectively shut down by the FDA in 2018. The agency worriedthe tests could pose significant public health concerns as inaccurate test results could impact the decision-making of healthcare providers and patients in ways that are seriously detrimental to patient health.

The agency walked that back slightly earlier this year, creating a Table of Pharmacogenetic Associations, which lists gene-drug interactions the agency believes are based on sufficient scientific evidence based on published literature.

For now, a genetic test needs to be ordered by a physician, who may or may not be able to interpret the code. And genetics remains just one element that doctors and patients should consider, including age, weight and environmental factors.

But patients like Armstrong say breaking the genetic code shouldnt be a secret it could literally spare them a lifetime of pain. Given the chance early on, she said, I would have had that test done in a heartbeat.

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Breaking the Code: A lifetime of pain, due to genetic drug intolerance - FirstCoastNews.com WTLV-WJXX

Recommendation and review posted by Bethany Smith