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Archive for the ‘Genetic medicine’ Category

Scientists discover breakthrough toward treatment of Fragile X syndrome the leading genetic cause of autism – UCalgary News

Thursday, June 4th, 2020

Scientists at the Hotchkiss Brain Institute (HBI), Alberta Childrens Hospital Research Institute (ACHRI), and Owerko Centre at UCalgarys Cumming School of Medicine (CSM) have made a breakthrough discovery that could lead to treatment of Fragile X syndrome (FXS), the leading genetic cause of Autism Spectrum Disorder. The study, involving mouse models, shows promise of translating to treatment for people diagnosed with FXS.

FXS causes intellectual disabilities and hyperactive behaviour, usually more commonly seen in males than females. Children and adults with FXS are missing a protein vital to brain development called FMRP. Among other functions, FMRP helps develop synapses between neurons in the brain.

Dr. Raymond W. Turner, PhD, and members of his study team including Drs. Xiaoqin Zhan, PhD, Hadhimulya Asmara, PhD, and Ning Cheng, PhD, made the discovery while studying ion channels in the brain special proteins that conduct currents through cells, enabling communication within the brain.

If I had to make an analogy, it might be akin to insulin and diabetes. With FXS, individuals are missing this protein lets try putting it back in, says Turner, study lead, and professor in the departments of Cell Biology and Anatomy, and Physiology and Pharmacology at the CSM. In 30 minutes, the protein distributed throughout the brainand accomplished what its supposed to do at the single-cell level.

Unlike injected insulin, which helps someone with diabetes control their blood sugar for a few hours, the FMRP injection helps restore protein levels in the cerebellum and brain for up to one day after the injection. Hyperactivity was reduced for almost 24 hours, says Zhan, a postdoctoral scholar in the Turner lab.

We did one injection and we tested for it one day later, and three key proteins that are known to be in Fragile X were still at restored normal levels.

In other, unsuccessful attempts to inject mouse models with FMRP to mitigate FXS, scientists used the entire molecule. But Turner and his colleagues used a fragment of FMRP which was able to cross the blood-brain barrier.

Its not a full FMRP molecule at all but rather a fragment with important structural features and functional components that are active in doing things like controlling ion channels or the levels of other proteins, says Cheng, a research associate in the Turner lab.

Extensive FMRP expression in normal brain (A) is missing in FMRP knockout mice (B) but restored one hour after tat-FMRP injection (C).

Turner lab

In the next phase, the researchers will investigate using other parts of the FMRP molecule to mitigate cognitive disorders associated with FXS. Unlike a lot of drug therapies where you hope you can get your drug to one specific group of cells, FMRP is expressed in just about every cell in the brain, so an all-encompassing wide-based application is what you want, says Turner.

Beyond potential treatments for FXS, the research could help develop treatments to offset behavioural symptoms characteristic of other Autism Spectrum Disorders.

The findings are published in Nature Communications.

Funding for the study was provided by the Canadian Institutes of Health Research (CIHR), Alberta Children's Hospital Foundation through ACHRI, Simons Foundation Autism Research Initiative (SFARI) Explorer grant, and fellowship support from FRAXA and Fragile X Research Foundation of Canada, the HBI and CSM Postdoctoral Fellowship programs.

This technology has a patent through Innovate Calgary, the universitys knowledge transfer and business incubator centre, which continues to develop its commercial path through partnership/investment to advance this discovery as a viable treatment for patients.

The Turner lab works on the role of an ion channel complex they discovered that controls multiple functions in the cerebellum that led them to look at the effects of losing FMRP in the knockout mouse model. The reason replacing FMRP was so effective is that it turns out to be part of the very ion channel complex the lab has been studying for 10 years.

Led by theHotchkiss Brain Institute,Brain and Mental Healthis one of six research strategies guiding the University of Calgary toward itsEyes Highgoals. The strategy provides a unifying direction for brain and mental health research at the university.

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Prescient Metabiomics and the Harvard Chan Microbiome in Public Health Center Collaborate to Advance Research in Colon Cancer Screening – Stockhouse

Thursday, June 4th, 2020

CARLSBAD, Calif., June 2, 2020 /PRNewswire/ -- Prescient Metabiomics, a subsidiary of Prescient Medicine Holdings, Inc., announced today a research collaboration with the Harvard Chan Microbiome in Public Health Center (HCMPH Center), a group at Harvard T.H. Chan School of Public Health dedicated to expanding research on the microbiome to improve public health. The aim of the collaboration is to study microbial biomarkers to identify the presence of precancerous adenomas and carcinomas in the colon. The initial collaboration will investigate prevalent gut microbial biomarkers for colorectal cancer (CRC) by analyzing known, recent CRC cases across populations with which the HCMPH Center works and applying cutting-edge statistical and bioinformatic techniques for microbiome meta-analysis.

"The ongoing research collaboration will further enhance diagnostic screening for colon cancer," said Keri Donaldson, M.D, chief executive officer at Prescient Medicine. "Offering a non-invasive alternative to colonoscopies that screen for colorectal adenomas and carcinomas could represent a paradigm shift in CRC screening driven by the microbiome. Therefore, research to better understand the microbiome's role in CRC is needed at this time."

Curtis Huttenhower, Ph.D., professor of computational biology at Harvard Chan School and co-director of the HCMPH Center, said, "The mission of the HCMPH Center is to improve population health via microbiome science, and there are few chronic disease conditions as well-positioned to benefit from microbiome screening as colorectal cancer. It is one of the most common causes of cancer deaths, but also one of the most preventable cancers if detected early. It's exciting to embark on this collaboration to advance the latest science and, I hope, eventually deploy our findings to the clinic."

The past decade has seen a dramatic expansion of research on the human microbiome, including investigation into the role of microbes and microbiota in the gastrointestinal track in the origin and development of CRC. The advancements in this field parallel the preceding decade's growth in personalized genetic medicine, with the microbiome offering opportunities for both therapeutic and diagnostic biomarker discovery.

According to the American Cancer Society, colorectal cancer is the third leading cause of cancer-related deaths in both men and in women. The U.S. spends approximately $14 billion each year for the diagnosis and treatment of CRC with costs largely due to delayed detection. There is a lack of non-invasive screening tests that can accurately detect precancerous polyps as effectively as a colonoscopy, the current standard of care. Screening recommendations currently suggest a colonoscopy for average-risk patients starting at age 45 every 10 years and earlier for high-risk patients, but approximately one in three patients are not in compliance with these recommendations. Research indicates that early detection of precancerous adenomas and carcinomas could lead to significantly better patient outcomes.

About Prescient Metabiomics Prescient Metabiomics LLC, a privately held company and subsidiary of Prescient Medicine Holdings, Inc., is an early stage molecular diagnostics company developing in-vitro diagnostics that leverage breakthroughs in next-generation DNA sequencing, computational systems biology, and human microbiome sciences. To learn more, visit http://www.metabiomics.com.

About Prescient Medicine Holdings Prescient Medicine Holdings, Inc. is a privately held company focused on developing diagnostic tools that advance the precision healthcare movement. Prescient Medicine's mission is to accelerate the development, commercialization and deployment of advanced clinical diagnostics to address the most pressing public health issues in the U.S. Prescient Medicine designs powerful tests and analytic solutions to offer deep predictive insights so doctors and patients have the data they need to make more informed clinical decisions and achieve the best possible patient outcomes. Prescient Medicine technologies include LifeKit® Prevent designed to detect colon cancer and precancerous adenomas and LifeKit® Predict, an in vitro diagnostic test commercialized in partnership with its subsidiary AutoGenomics, used for the identification of patients who may be at risk for opioid dependency. To learn more, visit http://www.prescientmedicine.com.

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SOURCE Prescient Medicine; Prescient Metabiomics

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Prescient Metabiomics and the Harvard Chan Microbiome in Public Health Center Collaborate to Advance Research in Colon Cancer Screening - Stockhouse

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Global Tumor Genomics Market: Focus on Products, Techniques, Applications, End User, Cancer Type, 14 Countries Data, Industry Insights and Competitive…

Thursday, June 4th, 2020

New York, June 04, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Tumor Genomics Market: Focus on Products, Techniques, Applications, End User, Cancer Type, 14 Countries Data, Industry Insights and Competitive Landscape - Analysis and Forecast, 2019-2028" - https://www.reportlinker.com/p05903975/?utm_source=GNW By Technique: Next Generation Sequencing Technique (NGS), Polymerase Chain Reaction (PCR), Microarray, In-Situ Hybridization (ISH), Immunohistochemistry (ICH), Others (Mass Spectrometry and Flow Cytometry) By Application: Diagnostics and Monitoring, Drug Discovery and Development, and Biomarker Discovery By End User: Academics and Research Organizations, Hospitals and Ambulatory Clinics, Clinical and Diagnostic Laboratories, and Biotechnology and Pharmaceutical Company By Cancer Type: Leukemia, Breast Cancer, Melanoma, Colon Cancer, Lung Cancer, Prostate Cancer, Head and Neck Cancer, and Others (Ovarian, Pancreatic, and Testicular)

Regional Segmentation

North America U.S., Canada Europe Germany, U.K., France, Italy, Spain, Netherlands, Rest-of-Europe Asia-Pacific Japan, China, Australia, India, Rest-of-Asia-Pacific Rest-of-the-World Latin America and Middle East & Africa

Growth Drivers

Rising Government Initiatives and Projects Increasing Incidence of Cancer Increasing Number of Product Approvals and Launches Ever Expanding Application Areas for Genomics Increasing Use of Biomarkers in Cancer Profiling

Market Challenges

High Cost of Genomic Equipment Lack of Unified Framework for Data Integration

Market Opportunities

Growing Prominence for Precision Medicine Increasing Demand for Point-of-Care Diagnostics

Key Companies Profiled

Thermo Fisher Scientific Inc., Illumina, Inc., QIAGEN, Agilent Technologies, Inc., Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd, Merck KGaA, Pacific Biosciences of California, Inc., Myriad Genetics, Inc., and PerkinElmer.

Key Questions Answered: What is tumor genomics? How the different tumor genomic techniques have evolved over the years? What are the major market drivers, challenges, and opportunities in the global tumor genomics market? What was the global tumor genomics market size in terms of revenue in 2019? How is the market expected to evolve in the upcoming years? What is the market size expected to be in 2028? How is each segment of the global tumor genomics market expected to grow during the forecast period between 2020 to 2028 and what is the revenue expected to be generated by each of the segments by the end of 2028? What are the developmental strategies implemented by the key players to sustain in the competitive market? What is the growth potential of the tumor genomics market in each region, namely, North America, Europe, Asia-Pacific, and the Rest-of-the-World? Which product among the two (assays and kits & instrument) are offered by key players such as Thermo Fisher Scientific, Illumina Inc., Qiagen N.V., and F. Hoffmann-La Roche Ltd.? Which technique is leading the market in 2018 and expected to dominate the market in 2028 and why? Which application and end user type are leading the market in 2019 and are expected to dominate the market in 2028 and why? Which region dominated the global tumor genomics market in 2019 and what are the expected trends from each of the regions in the forecast period 2020-2028?

Market Overview

In order to meet the growing product demand and need, companies are investing in the assays, kits, and instruments used in tumor genomics.Nowadays, large number of kits and reagents are used to test the profiling of mutated genes.

For instance, companies such as Thermo Fisher Scientific, Illumina, Inc., and QIAGEN N.V. have focused on the development of variety of kits for the detection of rare genetic diseases due to cost-effectiveness of the kit as compared to instrument and software, which in turn is causing widespread utilization of kits globally.

The market is also witnessing the launches of various products by receiving FDA approvals such as assay for the study of genes and molecular characterization of DNA. For instance, on, January 16, 2019, QIAGEN received approval from Japanese Pharmaceuticals and Medical Device Agency (PMDA) on therascreen EGFR RGQ PCR Kit which is used as a companion diagnostic for lung cancer patients on treatment with Dacomitinib.

Similarly, several manufacturers are also launching innovative products to expand their offerings in the market. For instance, on November 6, 2019, Thermo Fisher Scientific launched Ion Torrent Genexus System, which is a fully integrated next generation sequencing platform used for profiling of genomes.

The market is favored by multiple factors, which include rising government initiatives, increasing incidence of cancer, therefore increasing the utilization of sequencing to identify the mutant DNA segments, increasing number of product approvals and launches pertaining to genomics market. Moreover, increasing use of biomarkers in cancer profiling is also one of the key driving factors for tumor genomics market.

Government funding is also one of the major growth factors for tumor genomics market, because increasing funding by the government help the research institutes to develop sequencing systems useful for the diagnosis of genetic diseases.Increasing funding shall lead to liquidity of the genomics market and thus companies shall develop various sequencing systems to identify the mutation in the segments of DNA.

All these factors are thus expected to contribute to the market growth during the forecast period.

Within the research report, the market is segmented on the basis of product type, techniques, application, end user, cancer type, and region, which highlight value propositions and business models useful for industry leaders and stakeholders. The research also comprises country-level analysis, go-to-market strategies of leading players, future opportunities, among others, to detail the scope and provide a 360-coverage of the domain.

Competitive Landscape

Major players including QIAGEN N.V., Illumina, Inc., Abbott Laboratories, F. Hoffmann-La Roche Ltd. Thermo Fisher Scientific, and BGI, among others, led the number of synergistic developments (partnerships and alliances) witnessed by the market. On the basis of region, North America is expected to retain a leading position throughout the forecast period 2019-2029, followed by Europe. This is a result of the presence of leading industry players in these regions, and a higher adoption rate of sequencing system to detect the mutation in genes and DNA segments. Moreover, growing research in the field of sequencing technologies including next-generation sequencing technologies (NGS) is one of the drivers that promote the growth of the tumor genomics market.

Countries Covered North America U.S. Canada Europe Germany U.K. France Italy Spain Netherlands Rest-of-Europe Asia-Pacific (APAC) China Japan Australia India Rest-of-Asia-Pacific Rest-of-the-World Latin America Middle East & AfricaRead the full report: https://www.reportlinker.com/p05903975/?utm_source=GNW

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

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Experts answer your COVID-19 questions: ‘Is there testing we should have done when drinking from my granddaughter’s soda or any additional measures?’…

Thursday, June 4th, 2020

Have a question about coronavirus, also known as COVID-19?

We will ask the experts.

Send questions to tribdem@tribdem.com.

A reader of The Tribune-Democrat asked:

After much concentration with social distancing and staying at home I inadvertently drank from a soda my granddaughter had been drinking from. She is from a family of four with no apparent symptoms. I am 70 years old with Type 2 diabetes. Is there testing we should have done following this incident or any additional measures? Im nervous that after all my efforts the past 2 1/2 months that I will contract the virus.

The answer:

I congratulate you on all your efforts and safe practices. In my opinion, no testing is indicated unless you develop any symptoms or fever, and no additional measures are needed.

I believe your risk is very low concerning the one incident which you described, and I would not worry. I do recommend that you continue social distancing, good hand washing hygiene, and wearing a face mask. Youre doing a great job!

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

My employer has required me to havetwo negative tests before returning to work. How long do I have to wait after my first negative test before I can get my second test?

The answer:

The CDC has placed guidelines concerning returning to work after recovery from COVID-19.

These guidelines state that an individual should havetwo consecutive negative results of an FDA-approved COVID-19 molecular assay for detection of SARS-CoV-2 RNA from at least two consecutive respiratory specimens collected greater than 24 hours apart.

Therefore, the least amount of time between testing that can occur is 25 hours.

It is important to point out that an individual must havetwo consecutive negative tests, and results for these tests can take several days to be returned to the individual.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

I am a personal trainer who has had an 89-year-old client request that I come to her home to train her. Besides being a trainer, I also have a part-time job at a regional airport near my home where I handle bagsand check in passengers, as well as cleaning the plane. I am very careful when I work about wearing a mask, gloves, using social distancing and washing my hands. Is it safe for my client if I train her?

The answer:

Im glad that you are using personal protective equipment (PPE) and practicing good hand-washing hygiene. The question of risk exposure for an 89-year-old individual is not insignificant, even though you are taking appropriate precautions.

In the United States, the highest incidence of severe outcomes with COVID-19 were in patients older than 85. Therefore, visitors other than caregivers are not recommended.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

I am 75 and have Post Polio Syndrome, chronic bronchitis and shingles. My husband is going back to work at an auto glass manufacturer. How can I isolate in my home? We also have three dogs. Could they carry the virus to me if he gets sick?

The answer:

Self-isolate in a private room and use a private bathroom, if possible. Wear a mask when you enter general living areas. Follow other Pennsylvania Department of Health and CDC recommendations and precautions including good hand-washing hygiene and frequently clean with a sanitizer common surfaces you may both touch.

CDC is aware of a small number of pets worldwide, including cats and dogs, reported to be infected with the virus that causes COVID-19, mostly after close contact with people with COVID-19. Based on the limited information available to date, the risk of animals spreading COVID-19 to people is considered to be low.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

I have symptoms of COVID-19 and am scheduled to do my test this morning. It will taketwo days to get results. Is it safe to use my inhaler and nasal spray? And if my test is positive, is it safe to use my inhaler and nasal spray?

The answer:

Im not aware of any inhaler and/or nasal spray contraindications with SARS-CoV-2 (COVID-19). I recommend that you follow-up with your primary care physician.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

If the virus has a very short life in/on non-living environments, why is it so important to deep clean spaces that have been vacated for several months?

Wouldnt routine cleaning suffice before the space is occupied again?

The answer:

Cleaning spaces that have been vacant for several months with a deep cleaning is a good idea in general. Many microbes could be present on these surfaces (Staphyloccous and Streptococcus species for example).

There have been news stories circulating that the CDC has changed their guidelines on how SARS CoV-2 spreads. This is untrue. The CDC merely placed the contaminated surfaces under a subcategory stating that the virus does not easily spread via contaminated surfaces. Both the old and new versions of the recommendations state that it is known that the virus can survive on contaminated surfaces for hours to days depending on the surface.

The best way to reduce risk of infection is to wash your hands regularly and clean surfaces with soap and water followed by a disinfectant.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

My husband had COVID-19 symptoms, a sore throat,and because he is 63 years old, we wanted to check to see if he is OK. His results came back positive and he is on a 14-day quarantine. We have now all been tested in the family. So far my youngest daughters results came back negative. Should she move out to be safe?

The answer:

I am assuming the test that all of you received was the genome test. If your husband was positive for the genome, that is indicative of an active infection. This means he is contagious. He needs to quarantine himself and limit the exposure to other family members. It is recommended that high-touch surfaces be cleaned multiple times a day as well.

It is prudent for your daughter (and any other family member who tested negative) to self-isolate in a separate part of the home. Since she is currently living in your home and your husband tested positive, there may have been exposure to SARS CoV-2 since the testing. Testing gives us a snapshot of what is occurring, and since you are all in the same household, there could have been exposure after testing.

If she has a place to go to for 14 days where she is not risking exposure to others, you may want to consider having her go there.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

If I pick up the virus from someone at noon, how soon do I start infecting others?

The answer:

A small number of studies suggest that some people can be contagious during the incubation period, the time between exposure to the virus and the onset of symptoms. The incubation period for SARS-CoV-2 (also known as the COVID-19 virus) is estimated to be between two and 14 days, with a median of five to seven days (possibly longer in children). Greater than 95% of patients develop symptoms within 10-12 days of infection.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

My ex and I have shared custody. She just called to say shes in quarantine waiting for COVID-19 test results. I have the children now, but she had them last week before her quarantine.

Do we need to quarantine now until we hear her results? From a concerned father.

The answer:

Yes, self-isolate to your home while you wait for her results. Whoever else lives in your home should also stay at home. Close contacts are people who have been withinsix feet of you for a period of 10 minutes or more. If you or the children develop symptoms, notify your health-care provider for instructions and testing.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

How can I keep COVID-19 from spreading in my home once I turn on my whole-house air conditioning? My husband works and I am doing my best to isolate him in his room and a bathroom across the hall.

The answer:

There have been two studies that show the airborne droplets containing SARS-CoV2 can spread farther than six feet when the airflow in a room is increased (either from an air conditioner or a heating system). These systems often draw air in from a room and cool it, sending the cool air throughout the home and the heat outside. This type of system has the potential to circulate the virus in a home if someone is infected.

A study out of the University of Oregon together with the University of California-Davis says the best way to reduce the spread of the virus and still ventilate a room is to open a window. Opening a window in the home will reduce the possible virus concentration by increasing the concentration of air from the outside.

If you cant open the window (allergies, asthma, 95-degree heat) and there is concern that someone in the home is infected (showing symptoms, asymptomatic or exposed), you could block the intake vent in the room(s) that individual is isolating in.

Duct tape can cover the vent and help to reduce the spread of the virus through the home.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

Is there a COVID-19 test my 3-year-old grandson can take that would allow him to stay with us for a day or two if he tests negative? I am 71, and would do anything to see him again.

The answer:

Molecular (Polymerase Chain Reaction PCR) swab test detects RNA from SARS-CoV-2, also known as the COVID-19 virus. If the PCR is positive, the patient is considered infected with the COVID-19 virus and presumed to be contagious.

You mention testing your grandson, but also consider testing the grandparents as well. However, it is important to emphasize that a negative PCR does not exclude COVID-19.

Also, realize that the mean incubation period for COVID-19 is five days, and the range can be two to 14 days. This means that a negative result does not rule out infection.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

If a persons antibody IgGand IgM came back positive, are they able to spread the virus because of the IGM result?

The answer:

Testing shows us a snapshot of what is happening with a person andhis/her course of disease. The two types of antibody tests are looking for a particular type of immune response.

When we are exposed to a pathogenic microbe, our immune system has two ways to defeat it.

The first is called the innate response. This response is encoded in our DNA as a human.

It is nearly the same for all of us (with minor differences). This response causes inflammation. It is non-specific and only reacts to each pathogen based on its particular type.

For example, all bacteria are treated the same. It cannot distinguish Streptococcus pyogenes from Staphylococcus aureus. It doesnt distinguish an adenovirus from the Ebola virus.

Most of the time, this innate response kills the invading microbe. When it doesnt, that is when we see symptoms of a disease.

When the innate response cant destroy all of the microbes, then we see the adaptive response.

The adaptive response is specific. This response is different in every individual.

We have a complex immune genetic system to take gene segments and piece them together to create an entirely new gene. Its called somatic recombination. Our germline DNA is pieced together to give us a new never before seen gene to fight a specific pathogen.

That gene is then turned into a protein and made into an antibody for the specific pathogen.

The first antibody made when fighting that response is IgM. If this is found in a test, it indicates the person is in the early stages of the specific response to the virus. IgG is made later, about 14 days into the infection, in the specific response and is often the antibody that allows our immune response to remember the infection (it is made for a few months to years afteran infection).

If a person tests positive for IgG, thatwould suggest theindividual was infected sometime in the past. Ifhe or she is symptomatic, theperson would still be able to transmit the SARS CoV-2 to others, but in most cases the IgG test would be positive after the disease has run its course.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

If a person had COVID-19 in the past, lets say in February, and takes the testagain in May, is the test going to show negative? In other words you could have hadcoronavirus in the past and it would test negative now?

So, the only way to find out if you had it in the past would be the antibody test, correct?

The answer:

Great questions, and it all comes back to testing and more frequent testing. Theres some very recent positive data out of South Korea which Ill discuss below.

Your questions refer to the different types of tests. One test is the molecular swab (Polymerase Chain Reaction PCR), which detects genetic RNA from SARS-CoV-2, also known as the COVID-19 virus. The other test is a blood IgG antibody, which determines if someone was previously infected, or was recently exposed to the virus 10-21 days ago.

If you had COVID-19 infection in February, the PCR swab test would probably be negative now, and the blood IgG antibody test would probably be positive (indicating prior infection). Recent data out of South Korea suggest that if the repeat PCR swab test is positive, that may be detecting dead virus, rather than indicating reinfection. And the positive IgG antibodies may provide some protection.

Because the pandemic is only a few months old, there is no data on long-term immune response.

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Evogene to Participate in CRISPR-IL Consortium to Provide End-to-End Artificial Intelligence System for Genome-Editing – PRNewswire

Wednesday, June 3rd, 2020

REHOVOT, Israel, June 3, 2020 /PRNewswire/ -- Evogene Ltd. (NASDAQ: EVGN) (TASE: EVGN.TA), a leading computational biology company targeting to revolutionize life-science product development across several market segments, announced today its participation in the CRISPR-IL consortium. The goal is to develop "Go-Genome", an artificial intelligence (AI) based, end-to-end system for genome-editing to be used in multi-species for pharma, agriculture, and aquaculture. Evogene's CSO, Dr. Eyal Emmanuel will serve as the Chairman of the consortium.

The CRISPR-IL consortium has been approved for 1.5 years by the Israeli Innovation Authority and may be extended to an additional 1.5 years. The consortium's total budget (for the first period) is approximately ILS 36 million (roughly $10 million), partially funded by a grant from the Israeli Innovation Authority. CRISPR-IL participants include leading companies, medical institutions, and academic institutions. Apart from Evogene, key participants include BTG Bio-technology General Israel, Colors Farm, Hazera Seeds, NRGene, Pluristem, Rahan Meristem Ltd., TargetGene; medical institutions: Sheba Medical Center, Schneider Children's Medical Center; and academia: Bar-Ilan University, Ben Gurion University of the Negev, Hebrew University of Jerusalem, IDC Herzliya, Tel-Aviv University and the Weizmann Institute.

CRISPR is a genome-editing technology for detecting and modifying DNA sequences. It is used as a tool to enable precise genetic alterations without the introduction of foreign DNA. The technology enables the development of unique bio-based products and novel therapeutics while reducing the time and cost of development. Current CRISPR-based workflows target precise areas within the DNA, however, these workflows still face several challenges, which prevent more extensive use of this tool, including: (i) accidental off-target modification, (ii) inefficient modifications and (iii) inaccurate measuring tools to ascertain that the modification was effective as intended.

The CRISPR-IL consortium intends to develop an artificial intelligence-based system, "Go-Genome", providing users improved genome-editing workflows. The system aims to provide end-to-end solutions, from user interface to an accurate measurement tool. The system is expected to include the computational design of on-target DNA modification, with minimal accidental, off-target modifications, improve modification efficiency and provide an accurate measuring tool to ensure the desired modification was made. This system intends be designed to be effective in multi-species, including human, plant, and certain animal DNA applicable to market segments in pharma, agriculture and aquaculture.

Evogene's work in the consortium is expected to include the broadening of its artificial intelligence capabilities that are expected to extend the range of itsGENErator AIsolution (part of Evogene's CPB platform). Evogene'sGENErator AIsolution already includes computational capabilities directing "which"edit should be made to achieve a specific trait; and the capabilities developed within the framework of the consortium aim to improve"how"these edits are made.

Dr. Eyal Emmanuel, Chairman of the CRISPR-IL consortium and CSO of Evogene commented: "Our mission is to position Israel as a top technological hub for the use of AI in genome editing. The all-encompassing system the consortium aims to develop, is expected to expand the scope of Evogene's discovery and development offerings for genetic elements, including for its subsidiaries. We believe this is a unique opportunity for applying computational biology and artificial intelligence to genome editing. We are excited to be leading this effort through decoding biology."

Prof. Avraham A. Levy, Chairman of Evogene's Scientific Advisory Board and Dean of the Biochemistry faculty at the Weizmann Institute of Science commented:"The workplan proposed by Evogene within the CRISPIL consortium addresses important gaps in our scientific understanding of the CRISPR technology. Evogene's unique computational analytical tools, together with the data produced by the consortium, have the potential to enable a more effective utilization of genome editing in medicine and agriculture, paving the road for novel products and treatments."

About Evogene Ltd.:

Evogene (NASDAQ: EVGN, TASE: EVGN.TA) is a leading computational biology company targeting to revolutionize product development for life-science based industries, including human health, agriculture, and industrial applications. Incorporating a deep understanding of biology and leveraging Big Data and Artificial Intelligence, Evogene established its unique technology, the Computational Predictive Biology(CPB)platform. The CPB platform is designed to computationally discover and develop life-science products based on microbes, small molecules and genetic elements as the core components for such products. Evogene holds a number of subsidiaries utilizing theCPBplatform, for the development ofhuman microbiome-based therapeutics, medical cannabis, ag-biologicals, ag-chemicals, seed traits and ag-solutions for castor oil production.

For more information, please visitwww.evogene.com

Forward Looking Statements:

This press release contains "forward-looking statements" relating to future events. These statements may be identified by words such as "may", "could", "expects", "intends", "anticipates", "plans", "believes", "scheduled", "estimates" or words of similar meaning.For example, Evogene is using forward-looking statements in this press release when it discusses the end-to-end solutions provided by the system to be developed and the expansion of the Company's artificial intelligence capabilities and solutions.Such statements are based on current expectations, estimates, projections and assumptions, describe opinions about future events, involve certain risks and uncertainties which are difficult to predict and are not guarantees of future performance. Therefore, actual future results, performance or achievements of Evogene and its subsidiaries may differ materially from what is expressed or implied by such forward-looking statements due to a variety of factors, many of which are beyond the control of Evogene and its subsidiaries, including, without limitation, the global spread of COVID-19, or the Coronavirus, the various restrictions deriving therefrom and those risk factors contained in Evogene's reports filed with the applicable securities authorities. In addition, Evogene and its subsidiaries rely, and expect to continue to rely, on third parties to conduct certain activities, such as their field-trials and pre-clinical studies, and if these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines (including as a result of the effect of the Coronavirus), Evogene and its subsidiaries may experience significant delays in the conduct of their activities. Evogene and its subsidiaries disclaim any obligation or commitment to update these forward-looking statements to reflect future events or developments or changes in expectations, estimates, projections and assumptions.

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Evogene to Participate in CRISPR-IL Consortium to Provide End-to-End Artificial Intelligence System for Genome-Editing - PRNewswire

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Sydney cardiologist honoured with Fulbright scholarship – Sydney Morning Herald

Wednesday, June 3rd, 2020

"There are so many unanswered questions, so many puzzles we are yet to solve," she said.

Dr Bart should have been on a plane on Monday, bound for Harvard University and the Brigham and Women's Hospital in Massachusetts for her 10-month Fulbright exchange placement, collaborating with fellow bright minds to unravel the complexities of cardiac genetics.

The Fulbright Program is a highly coveted US foreign exchange scholarship program, aimed at increasing bi-national research collaboration, cultural understanding and the exchange of ideas.

The COVID-19 pandemic has waylaid Dr Bart's travel plans and diverted her attention to the effects of the virus on cardiac patients. But she is continuing her research into the genetic roots of cardiac disease, in particular cardiac amyloidosis, where abnormal protein deposits amyloid fibrils build up in heart tissue, causing heart failure.

Amyloid heart disease used to be a death sentence, Dr Bart said.

"By the time we see patients and diagnose them, it's often too late. We had no treatment we could offer these patients until very recently," she said. "Now that we have those treatments we have a clinical imperative to diagnose early [using genetic testing].

"We are on this cusp of a genetics and genomic revolution where patients can be offered treatment based on their individual genetic make-up," Dr Bart said. "It's hugely exciting".

Being on the cusp of scientific breakthroughs seems like a fitting spot for the expert mountaineer. Dr Bart and her mother, Cheryl Bart, were first mother-daughter team to summit Everest and complete the "Seven Summits" challenge climbing the highest mountains on each continent.

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"I appreciate what it feel like to push your body to the extreme," she said.

"The thing about being in high altitudes, up about 8000 metres, you have to focus on the next step and breath. There's a mindfulness to that focus, and not worrying about the bigger problem. You have a plan in place and you just keep taking that next step."

It's an ethos she brings to her research in the male-dominated field. Women account for just 15 per cent of cardiologists in Australia.

"There is still a huge gender gap, and this is likely affecting outcomes in research," she said. "The fascinating thing about women's hearts is that they behave different to men's. The signs and symptoms are different. Women don't have that thumping elephant-on-the-chest pain. They have more subtle symptoms.

"It's imperative that we have more female specialists and we utilise our different ways of thinking. We need more people to think laterally and collaborate."

Associate Professor Anthony Schembri, chief executive officer at St Vincent's Hospital, described Dr Bart as "a compassionate specialist who cares deeply for each of her patients, at the same time as undertaking research from the bench to the bedside with the aim of achieving long-term improved outcomes in her field of cardiac genetics".

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Victor Chang Cardiac Research Institute executive director Professor Jason Kovacic said Dr Bart was "one of the many inspiring women in science, a trailblazer, pushing the boundaries and paving the way for hopefully more women considering a career as a researcher".

"It is a great honour to be awarded a Fulbright scholarship, and it is a reflection of Dr Bart's dedication to be at the forefront of medical research and ensure that studies are not undertaken in isolation but rather in collaboration with global partners to truly make a difference for patients suffering from heart disease," he said.

Kate Aubusson is Health Editor of The Sydney Morning Herald.

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Sydney cardiologist honoured with Fulbright scholarship - Sydney Morning Herald

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Personalized Cancer Drugs Market Key Companies and Analysis Top Trends by 2025 – Cole of Duty

Wednesday, June 3rd, 2020

Global Personalized Cancer Drugs Market: Snapshot

Genetic sequencing has proven that no two cancer cases are absolutely identical, heavily depending on genetic profiles of the patients, which defines their immunity power. But frequently, several promising pipeline drugs fail to reach the market for not being commonly useful for the masses. In this scenario, a small but increasing number of personalized cancer drugs are allowed by the FDA for the treatment of particular mutations. Nearly one third of cancer drugs are prescribed off-label, as it provides help to the patients immediately. These targeted agents are directed at specific molecular feature of the cancer cells and hence produce greater effectiveness with significantly less toxicity.

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The global market for personalized cancer drugs market is gaining traction from increased government support for precision-medicine. For example, in June 2016, the U.S. National Cancer Institutes revealed its plans to enroll thousand patients in a trial called NCI-MATCH, which is aimed at matching patients to twenty possible compounds on the basis of their genetic abnormalities. Along the similar lines, The American Society of Clinical Oncology has also announced a registry termed as TAPUR, collecting data on the fate of patients who receive personalized cancer drugs off-label.

Another factor driving the global personalized cancer drugs market is the falling cost of genetic sequencing, which is enabling the quick approval of drugs for off-label clinical trials on patients in need across the world.

Personalized Cancer Drugs Market: Overview

Personalized drugs, or customized drugs, are tailored to suit the needs of individual patients. Earlier, various patients suffering from the same type of disease were given the similar treatment plan. However, it became evident to physicians that a particular treatment worked differently for different patients, mainly owing to a varied genetic makeup. The concept of personalized medicine is based on the analysis of etiology of disease in individual patients and offers treatment that is more efficient, predictable, and precise.

Cancer is a common chronic disease and a major cause of fatality around the globe. The development of personalized cancer drugs has gained pace as they have relatively fewer side effects compared to standard drugs. Personalized cancer drugs target a specific protein or gene responsible for the growth and survival of a cancer type.

Personalized Cancer Drugs Market: Trends and Opportunities

The personalized cancer drugs market is primarily fueled by the rising prevalence of various cancer types such as lung cancer, breast cancer, prostate cancer, melanoma and leukemia, and colorectal cancer. According to the Surveillance, Epidemiology, and End Results Program sponsored by the National Cancer Institute (NCI), an estimated 13,397,159 people in the United States were affected with various cancer types in 2011. Moreover, in 2014, around 1,666,540 new cancer cases were diagnosed in the country, with nearly 585,720 deaths resulting from cancer. The personalized cancer drugs market is also driven by several advantages associated with this new treatment therapy and ongoing developments in the field of genetic science.

On the flip side, high cost associated with the genetic testing of patients and tumor samples may serve as a growth restraint on the market for personalized cancer drugs. In addition to this, the lack of insurance plans to cover these tests in developing nations of Asia Pacific and Rest of the World hampers the market to some extent. This can be attributed to low per capita income and poor reimbursement scenario.

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Personalized Cancer Drugs Market: Geographical Assessment

From a geographical perspective, the personalized cancer drugs market has been broadly segmented into Europe, Asia Pacific, North America, and Rest of the World (RoW). The market for personalized cancer drugs is led by North America. The chief factors responsible for the regions lead position are aggressive research and development activities, technical advancements, higher affordability for expensive treatments and therapies, and greater healthcare awareness. Europe is also a key market for personalized cancer drugs owing to significant funding from several governments and the growing penetration by U.S.-based companies.

Asia Pacific holds immense promise for players in the personalized cancer drugs market, powered mainly by Japan. The regional market is likely to be fueled by the presence of a large pool of cancer patients and improving healthcare infrastructure. The growth of the APAC personalized cancer market can also be attributed to the rapidly evolving medical tourism industry. In the RoW segment, Mexico, Brazil, Russia, and South Africa represent potential markets.

Personalized Cancer Drugs Market: Competitive Landscape

Some of the key players competing in the personalized cancer drugs market are F. Hoffmann-La Roche Ltd., Pfizer Ltd., Cell Therapeutics, Inc., H3 Biomedicine, Inc., bioTheranostics, GlaxoSmithKline, and Abbott Laboratories. Zelboraf (vemurafenib) by F. Hoffmann-La Roche Ltd. and Xalkori (crizotinib) by Pfizer Ltd. are some notable targeted drugs for the treatment of cancer.

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Personalized Cancer Drugs Market Key Companies and Analysis Top Trends by 2025 - Cole of Duty

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Growth in Sales of Genomic Medicine Market to be Largely Driven by Rising Consumer Adoption – Cole of Duty

Wednesday, June 3rd, 2020

The National Human Genome Research Institute definesgenomic medicine asan emerging medical discipline that involves using genomic information about an individual as part of their clinical care (e.g., fordiagnostic or therapeutic decision-making) and the health outcomes and policy implications of that clinical use. Genomic medicine is a type of precision medicine in which genomics, epigenomics and other related data is used to accurately aid in individual disease diagnosis. Genomic medicine has novel applications in the fields of oncology, pharmacology, rare and undiagnosed diseases, and infectious disease.Genomic medicine paves way for personalized medicine into clinics and has immense potential to reach the physicians and patients. Genomic medicine has been used for advanced sequencing in cancer pharmacogenomics, rare disorder diagnosis and for tracking of outbreaks of infectious diseases.

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Genomic Medicine Market: Drivers & Restraints

Backed by government investments in precision medicine initiatives such as a multimillion dollar investment by President Obama in January 2015 which aims to improve how to treat and prevent a disease by laying emphasis on its genetic makeup is expected to boost the market growth. Clinical validity and utility of genomic medicine tests is a major issue witnessed in the global market. Also, lack of awareness among healthcare professionals, sluggish adoption of genome medicine, fluctuating regulatory landscape are the factors which could hamper growth of the global genomic medicine market.

Genomic Medicine Market: Segmentation

The global genomic medicine market is classified on the basis of application type, end use and region.

Based on application, the global genomic medicine market is segmented into the following:

Based on end use, the global genomic medicine market is segmented into the following:

Genomic Medicine Market: Overview

Genomic medicine is gaining momentum with expanding applications ranging from risk assessment and diagnosis in healthy individuals to genome-based treatment for patients with complicated disorders. Oncology is a major application of genomics medicine during cancer screening process as diagnostics for genetic and genomic markers. Oncology segment is expected to account for a major share in the global genomic medicine market. Genomic medicine is increasingly being used not only for research purpose but also in clinical applications. In clinical applications, genomic medicine will potentially enhance patient care.

Genomic Medicine Market: Region wise Overview

Geographically, global Genomic Medicine market is classified into regions viz. North America, Latin America, Western Europe, Eastern Europe, Asia Pacific Excluding Japan (APEJ), Japan, Middle East and Africa (MEA). Owing to the presence of large number of academic as well as research institutions in the U.S. which are working on genomic medicine to discover next-generation genomic medicines, North America region is projected to lead the global genomic market in terms of value during the forecast period. Also, the presence of several universities offering educational programs coupled with opportunities in scientific research of genomic medicine in the North America and Europe is expected to have positive impact on the regional markets. The genomic medicine concept still in its nascent stage is yet to receive an impetus from the emerging market which are anticipated to hold smaller shares in the global market.

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Genomic Medicine Market: Key Players

The key research institutes in global genomic medicine market are BioMed Central Ltd., Cleveland Clinic, The University of Texas MD Anderson Cancer Center, The Manchester Centre for Genomic Medicine, Center for Genomic Medicine to name a few. The focus of the top players will be on the identification of effective drug candidates particularly in cancer treatment based on the molecular structure of tumors.

The research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, and statistically supported and industry-validated market data. It also contains projections using a suitable set of assumptions and methodologies. The research report provides analysis and information according to categories such as market segments, geographies, accessories and applications.

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Growth in Sales of Genomic Medicine Market to be Largely Driven by Rising Consumer Adoption - Cole of Duty

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Inside the super-soldier arms race to create genetically modified killing machines unable to feel pain or fe – The Sun

Wednesday, June 3rd, 2020

THE ultimate warrior would be unable feel fear or pain, capable of running at Olympic speeds, and even immune to modern weapons.

Their existence was once only possible in the realm of science fiction but a new worldwide arms race is pitting nation states against each other to be the first to successfully create real genetically modified super soldiers.

Militaries have a long history of using powerful drugs to temporarily turn their troops into transcendant Terminator-style killers.

Nazis took methamphetamine or "crystal meth" during the Second World War to stay alert and awake for superhuman stretches of time.

And even the British military bought thousands of Modafinil pills which boost brain-power ahead of the Iraq War.

In China, it is reasonable to assume that they are enhancing their battlefield soldiers on all these fronts.

But with advances in technology, it could now be possible to alter soldiers' DNA to give them godlike powers all the time, from Herculean strength to lizard-like limb regeneration.

GM technology is proven with plants, it could absolutely be applied to the person, said Professor John Louth, an expert at defence think tank Rusi.

In China, it is reasonable to assume that they are enhancing their battlefield soldiers on all these fronts.

China's armed forces are the largest in the world, consisting of a staggering 2.2million personnel.

This year alone, Beijing is spending $178.16billion on its defence budget.

But as the country's international relations flare up, they could be looking to be the first army to have genetically modified super soldiers to get ahead of adversaries.

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These combatants would be stronger, faster and even smarter than their battlefield opponents.

Their DNA could also be adapted to help them recover more quickly from injuries or give them superior hearing and night vision.

The threat is obvious and real. Chinese money could be stealing a march on western armed forces and that is deeply concerning," Prof Louth said.

Concerns about China's super soldier plans came after a Chinese scientist, He Jiankui, claimed to have successfully created genetically modified babies using gene editing technology.

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China jailed Dr Jiankui for illegal medical practices over his claims to have made three babies immune to HIV.

But it's now suspected that Chinese military chiefs are backing trials into human gene editing.

But they're not alone.

The US has also conducted some strange super-soldier research projects.

They've already publicly unveiled a 5million Iron Man-style exoskeleton which gives fighters incredible muscle-power.

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And the Defense Advanced Research Projects Agency (DARPA) developed ways for warfighters to scale walls by studying the skin of geckos.

Novelist Simon Conway, who was granted behind-the-scenes access at the secretive Pentagon agency, revealed a string of other super soldier programmes underway there in 2012.

He claims scientists were working on gene modification that would allow soldiers' bodies to convert fat into energy more efficiently, allowing them to go days without eating.

What is gene editing?

"It's all about improving the efficiency of energy creation in the body," Conway told the Sunday Express.

"Soldiers would be able to run at Olympic speeds, carry large weights and go without sleep and without food."

But the US isn't just looking at how biotechnology can give their soldiers the upper-hand on the battlefield.

They're also carrying out research into medical regeneration, allowing severely injured soldiers who've lost limbs or suffered extensive burns to heal organically.

This is already a reality in the animal kingdom, where lizards can regrow amputated tails and salamanders can restore entire severed limbs.

"We would like it to be as restorative as possible, resist infection and be durable," said Army Lt. Col. David Saunders, extremity repair product manager for the U.S. Army Medical Materiel Development Activity.

"[There are] many wonderful things emerging in the field of regenerative medicine to restore form and function to our wounded warfighters."

As recently as January 2020, the US military was unveiling incredible advances in warzone genetics.

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Army researchers developed a gene therapy that allowed mice to create proteins that would protect them against nerve agents deadly chemical weapons that attack the nervous system, like the Russian Novichok used in the Salisbury poisonings in 2018.

The same gene therapy given to the mice that made them chemical weapon-proof could theoretically be used in soldiers entering hazardous environments.

Before Russia's nerve agents were used with terrible effect, president Vladimir Putin had warned of an even more terrifying weapon.

Speaking at a 2017 youth festival in Sochi, Putin spoke openly about the destructive possible consequences of gene-editing.

"A man has the opportunity to get into the genetic code created by either nature, or as religious people would say, by the God," he said, The Express reports.

"He can be a genius mathematician, a brilliant musician or a soldier, a man who can fight without fear, compassion, regret or pain.

"As you understand, humanity can enter, and most likely it will in the near future, a very difficult and very responsible period of its existence.

"What I have just described might be worse than a nuclear bomb."

But instead of this being something in the "near future", Russia is already factoring genetics into its military strategy.

Alexander Sergeyev, the head of the country's Academy of Sciences, revealed the armed forces were researching "genetic passports" in 2019, Forbes reports.

The passports would predict a soldier's "resistance to stress, ability to perform physical and mental operations under the conditions of this stress, and so on."

Sergeyev added that they could be used to sort which branch of the armed forces personnel would be sent to.

"There are already serious developments in this area," he said.

"It is about understanding at the genetic level who is more prone to, for example, to service in the fleet, who may be more prepared to become a paratrooper or a tankman."

What I have just described might be worse than a nuclear bomb.

And unlike other world leaders, Putin has a very close interest in genetic editing.

That's because his eldest daughter, Maria Vorontsova, is a scientist who specialises in genetic engineering and acts as his adviser on the matter.

In 2018, before He Jiankui revealed his HIV-immune babies in China, Putin had already allotted $2billion for genetic research, Bloomberg reports.

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He even put Vorontsova in charge of the 30-person panel overseeing the experiments.

Watching world superpowers will undoubtedly be paying attention to Putin's potential to weaponise the research.

After all, as Putin says, genetic editing is an area of science which will "determine the future of the whole world".

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Inside the super-soldier arms race to create genetically modified killing machines unable to feel pain or fe - The Sun

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COVID-19 Impact on Precision Medicine Market: Outlook, Growth, Key Driving Players and Industry Analysis Report 2026 – Cole of Duty

Wednesday, June 3rd, 2020

Precision medicine (PM) is an approach to patient care that allows doctors to select treatments that are most likely to help patients based on a genetic understanding of their disease. Personalized nanomedicine involving individualized drug selection and dosage profiling in combination with clinical and molecular biomarkers can ensure the maximal efficacy and safety of the treatment. The major hindrance toward the development of such therapies is the handling of the Big Data, to keep the databases updated. Robust automated data mining tools are being developed to extract information regarding genes, variations, and their association with diseases. Phenotyping, an integral part of PM, is aimed at translating the data generated at cellular and molecular levels into clinically relevant information.Precision Medicine Moves Care from Population-Based Protocols to Truly Individualized Medicine as President of the US announced the Precision Medicine Initiative in his 2015 State of the Union address. Under the initiative, medical care would transition from a one-size-fits-all approach to an individualized approach, in which data on each patients genomic makeup, environment, and lifestyle (the exposome) helps medical professionals tailor treatment and prevention strategies. To achieve the Precision Medicine Initiative mission statement, to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care, researchers and clinicians need vast and varied amounts of data and the technology to ensure that data is widely accessible and usable.

Browse Complete Report with TOC https://univdatos.com/report/precision-medicine-market-current-analysis-and-forecast-2020-2026

Insights Presented in the Report

Based on technology type, the market is fragmented into big data analytics, bioinformatics, gene sequencing, drug discovery, companion diagnostics, and others.Recent technological and analytical advances in genomics, have now made it possible to rapidly identify and interpret the genetic variation underlying a single patients disease, thereby providing a window into patient-specific mechanisms that cause or contribute to disease, which could ultimately enable the precise targeting of these mechanisms

Based on the market segment by application type, the market is segmented into oncology, respiratory diseases, central nervous system disorders, immunology, genetic diseases and others. With the advent of precision medicine, cancer treatment is moving from a paradigm in which treatment decision isprimarily based on tumor location and histology followed by molecular information to a new paradigm whereby treatment decisions will be primarily based on molecular information followed by histology and tumor location

Based on the market segment by end-user, the market is fragmented into hospitals & clinics, pharmaceuticals, diagnostic companies, Healthcare-IT firms and others. The precision medicine suppliers that understand technology and the goals of value-based healthcare can create value in the precision medicine value-chain by offering value-based solutions and platforms to interpret and connect data points. There are a number of technology companies who work in the field of precision medicine and more will be founded in the years to come

For better understanding on the market dynamics of Precision Medicine market, detailed analysis was conducted for different countries in the region including North America (United States, Canada, Mexico and Rest of North America), Europe (Germany, UK, France, Italy, Spain and Rest of Europe), Asia-Pacific (China, Japan, Australia, India and Rest of APAC), and Rest of World

Some of the major players operating in the market includeHoffmann-La Roche, Medtronic, Qiagen, Illumina, Abbott Laboratories, GE Healthcare, NanoString Technologies, bioMrieux SA, Danaher Corporation, and AstraZeneca

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Reasons to buy this report:

The study includes market sizing and forecasting analysis validated by authenticated key industry experts

The report presents a quick review of overall industry performance at one glance

The report covers in-depth analysis of prominent industry peers with a primary focus on key business financials, product portfolio, expansion strategies, and recent developments

Detailed examination of drivers, restraints, key trends and opportunities prevailing in the industry.

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The study comprehensively covers the market across different segments

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COVID-19 Impact on Precision Medicine Market: Outlook, Growth, Key Driving Players and Industry Analysis Report 2026 - Cole of Duty

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Why do you have that eye colour?: Exploring Health with Bamba – The Daily Herald

Wednesday, June 3rd, 2020

Authors: Bamba; Golden Jackson, PhD; Cristina Hernandez; Delroy Daley; and David Rodda, PhD, Associate Professor of Molecular Cell Biology of the AUC School of Medicine.

Hey friends! Its Bamba here and I cant wait to talk to you about some exciting, cool science today! This self-quarantine gave me a lot of time to think and I wondered, How do humans get the colour of their eyes?

Genetic expert, Dr. Rodda of AUC School of Medicine helped me explore this eye-opening mystery get it? Eye-opening? Ha-ha! Well, the answer to that question is in your genes not the ones you wear!

Did you know that humans are born with pre-made instructions? Yes, thats right! Humans and all other organisms have DNA that holds instructions, like a users manual, for how our bodies grow and develop!

DNA is a tiny, little molecule found inside every cell of our bodies and the instructions in the DNA are called genes. Genes determine how tall you will be, the texture of your hair, the colour of your eyes, and much more.

You have two copies of all your genes, one copy you received from your mother, the other copy you received from your father. Next, your genes in DNA are wrapped up in chromosomes the bundle that packages your genes together.

So, how do your genes determine your eye colour? According to experts, there are eight genes that control the colour of your eyes. You have two sets of these genes that came from each of your parents. Sometimes you might receive different versions of these genes from your parents.

For example, you may receive a gene that makes blue eyes from your father, and a gene that makes brown eyes from your mother. So, what colour would your eyes be then? That depends on what scientists call the dominance of the genes.

With eye colour, brown eyes are dominant, so if you have genes for both brown and blue eyes, your eyes will be brown. You can only have blue eyes if you don't have a gene for brown eyes. What about people who have green or hazel eyes? A different gene makes those colours, but still brown eyes are dominant, so just like with blue eyes, a person can only have green or hazel eyes if they dont have a gene for brown eyes.

Did you know you can have different coloured eyes than your parents? If a child is born to parents who both have brown eyes, there is a greater chance of their child having brown eyes, but there is also a chance their child can have blue or green eyes. The chart shows the likelihood (chance) of a child having eyes of a particular colour based on the colour of their parents eyes.

Did you know the amount of melanin you have in your eyes is another factor that helps determine eye colour? Melanin is a pigment that people have that normally determines how dark or light their features are. For example, a darker skinned person has more melanin in their skin than a lighter skinned person.

This is also true in eye colour. If your melanin gene is turned on high, then your eyes will be darker and browner. The less melanin in your eyes, then the lighter your eyes will be, resulting in green or blue eyes. No matter the size, shape, or shade of your skin, the colour of your eyes is based on genetics and chance!

Well there you have it! Another fun science exploration with you guys! Until next time, stay safe!

~Bamba out!

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Why do you have that eye colour?: Exploring Health with Bamba - The Daily Herald

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Venture capital found its footing in biotech. Then came the virus. – BioPharma Dive

Wednesday, May 27th, 2020

Amir Nashat has spent nearly two decades building biotechnology companies. The first he worked on, Alnylam Pharmaceuticals, pioneered a new way to make genetic medicine. He's since helped advise and nurture at least 16 others, several of which were acquired for hundreds of millions of dollars.

Despite this track record, Nashat, a partner at the venture firm Polaris Partners, says most of his career in venture capital took place under "really crappy circumstances" that made it challenging to invest in young drug companies. Only in the last five or so years did things really start to change.

It was during this period that public markets came to love young biotechs, buying into record stock offerings. Large drugmakers, starved for innovation, also turned to them for their next drugs. This created a "hyper-compressed, hyper-intense environment," according to Nashat, where venture firms had much clearer and quicker paths to earn returns on their investments. For venture capitalists, there had never been a better time to invest in drug startups and, coming into 2020, many expected another big year.

Their predictions were quickly upended by the spread of the new coronavirus, which has infected millions and brought the global economy to a halt. In the past, economic downturns shaped how venture firms fund and incubate drug companies. Now, a pandemic threatens to do the same.

BioPharma Dive spoke with half a dozen venture capitalists who grow drug companies, as well as legal and financial advisors who work with healthcare venture firms. Almost all said the spread of the new coronavirus is affecting to some degree how they manage existing investments or think about new ones.

"It used to be that we had a lot of chaos, but the rest of the world was predictable," said Noubar Afeyan, CEO of Flagship Pioneering, the biotech incubator which founded coronavirus vaccine developer Moderna along with more than 25 other companies. "Now, we have chaos and the rest of the world has chaos, and so there are some adjustments being done."

As venture capitalists assess the damage caused by the pandemic, they appear to be treading lightly financial data provider Pitchbook found biopharma venture deals are down roughly 16% compared to last year. Some firms told BioPharma Dive that, in the current environment, they'd be apprehensive to invest in certain kinds of drug companies.

Even small adjustments could have a lasting impact on the drug industry, given the vital role venture firms play in it. Many biotechs wouldn't exist without venture money and support, making these investors a powerful force over the drugs that could become available in the future.

After the recession in the early 2000s, scientific breakthroughs led to a surge in biotech investments, many of which would ultimately disappoint. When the financial crisis hit in 2008, healthcare-focused venture firms found it extremely difficult to raise money from their investors, who viewed biotech as a risky bet.

Their attitude didn't start to change until about 2013, by which time the recession was over and advances in drug research had made biotech more attractive to a wider group of investors and potential buyers. Biopharma acquisitions and initial public offerings, typically the two main ways venture firms receive returns, would hit record highs in the following years, giving these firms and their backers the confidence to keep putting in money.

Indeed, since 2013 there's been an annual uptick in the number of funding deals venture firms are doing, with almost every year having about 70 more than the one prior, according to Pitchbook. By 2019, the deal count had hit 941.

The collective value of these deals, which range from small angel investments to the larger funding rounds that follow, has grown too. In four of the last five years it surpassed $10 billion.

The favorable conditions also made it so that venture firms could go back to their investors for more money. Polaris Partners, 5AM Ventures, Third Rock Ventures and Versant Ventures, among others, each secured hundreds of millions of dollars across 2018 and 2019, while Flagship, Arch Venture Partners and venBio closed new funds this spring worth almost $3 billion combined.

Deerfield, a type of investor known as a "crossover" because it invests in both private and publicly traded companies, also just completed raising $840 million to put into healthcare companies.

While money has been plentiful, the economic disruption caused by the coronavirus raises doubts about whether that will continue.

Bob Nelsen, managing director at Arch, said he'd be surprised if any new, first-time funds can raise cash at all this year. Firms with existing networks of investor relationships may be able to pull off follow-on funds, he added, but they'd likely take longer to complete.

If a slowdown persists, young biotechs could find it difficult to close their next rounds of financing. Already, the pace of biopharma venture deals appears to be lagging, as Pitchbook counted 228 deals between early February and mid-May this year, down from the 271 seen in a similar time frame in 2019.

One top concern is that crossover investors, who often come in later and supply a substantial amount of the funding that props up a company until it goes public, will back away from biotech startups. Without those investors, early-stage venture backers might have to dig deeper in their pockets to push their companies forward.

"It can take $1 billion to get a drug to market," said Kristopher Brown, a partner in the life sciences group at law firm Goodwin. "There are few venture capitalists who can afford to fund that."

Nelsen predicts some crossover investors will take a break from biotech startups and focus on public stocks that are now cheaper because of a turbulent market. But Jon Norris, a managing director at Silicon Valley Bank who works on deals with healthcare venture firms, isn't so sure.

Biotech stocks have held up relatively well this year compared to the rest of the market, which Norris said bodes well for continued crossover interest. What's more, the number of biotechs that have gone public this year 14 as of May 26 is just a tick down from the 17 IPOs completed by the same date in 2019.

"It just means to me that people continue to see this sector as one that's worthy of investing," Norris said. "If you see good returns, people are not going to be quick to exit the market."

After dip, biotech stocks have outperformed the market

XBI vs S&P; 500, values indexed to Jan. 2, 2020=100

Still, much is unknown about how the pandemic will further unfold.

For drug companies, the impact of social distancing and its ripple effects on the economy are expected to be more dramatic in the second and third quarters. In a possibly foreboding sign, industry bellwethers Merck & Co. and Johnson & Johnson have lowered their revenue forecasts for the year by billions of dollars.

"I do worry about the delays that are inherent to having this whole economy come to a stop and hospital systems being overwhelmed," Norris said. "To me, that's a big deal over the next quarter."

In the meantime, venture firms need to put the money they've already raised to work.

Early-stage investors who spoke to BioPharma Dive said their core strategies are still intact in spite of the coronavirus. Flagship and Arch prefer companies with technology platforms that, in theory, can give rise to multiple drugs. Polaris, as it has in the past, works its close relationships with academic institutions to find new startup opportunities. Atlas Venture remains fairly agnostic, while San Francisco-based venBio looks for companies on track to hit a meaningful milestone in the next three to five years.

And yet, the pandemic does weigh on their thinking.

To attract new investors, development partners and potential acquirers, biotech startups need to hit goals like moving a drug into and through human testing. But they've found a new obstacle in the coronavirus. By late May, nearly 100 drug companies of all sizes had reported impacts to their clinical trials related to the pandemic.

"There could be significant dollars lost and significantly extended timelines" for biotechs on the verge of, or already in, clinical testing, said James Flynn, managing partner at Deerfield.

As such, some firms are investing more selectively. Aaron Royston, a managing partner at venBio, said his team will be "very cautious" when putting money into any drug company that's close to starting an important trial or launching a new product.

Funding also might be harder to come by for biotechs built around a single drug program, as there's not much cushioning if that program runs into complications.

"Companies that are purely based on single assets with a clinical readout are in deep shit," Nelsen said.

By contrast, companies at the earliest stages of research may benefit. Investors assume that, by the time these companies reach human trials, some of the challenges and uncertainties surrounding the coronavirus will have been ironed out.

Royston, for instance, said he has little apprehension investing in biotechs that will be working on early research for the next 12 to 18 months.

"Preclinical investment is almost a safe place to hide while everybody else is on the later-stage side, trying to figure out how to deal with delays in clinical trials," SVB's Norris said.

For now, venture firms say they've been more frequently checking in with companies that could face setbacks because of the disruption and, if needed, helping devise plans to conserve cash.

"At the end of the day, data is the currency of how we value our progress," said Atlas Venture partner Bruce Booth. "So, as long as the biotech has enough capital to get it through those data collections and can get out from some of those R&D delays, then I think we'll be in an OK place coming out of this crisis."

In responding to the disruption brought by the pandemic, venture capitalists may revisit approaches honed after the last big economic downturn in 2008.

Then, a dried up IPO market alongside difficulties raising money led some venture firms to leave life sciences investing altogether. Others doubled down on their existing strategies or adopted new ways to build companies.

Versant, for example, was known to start companies with a prearranged buyer in place. Atlas gave some companies, like Nimbus Therapeutics, a limited liability structure that made it easier to sell individual drugs to buyers, though more complicated to go public. Such tools are "less critical now than they were during that challenging period" because biotechs can still conduct IPOs, Booth says.

At Polaris, hard economic times reinforced the firm's trust in a type of group investing called syndicates, which can spread risk between firms. Flagship, on the other hand, backed away from forming biotechs with other investors because the process felt too restrictive.

"What we found was that, when people were traumatized through financing risks and through uncertainty, a syndicate was only as strong as its weakest link," Afeyan said. "In other words, if you had five investors sitting around a board table, the weakest one was the one that got to decide what you did."

Flagship has since shifted resources to focus almost exclusively on creating startups in its own labs. And it isn't alone. Firms such as Third Rock have become known for an intensely hands-on approach, incubating companies and ultimately owning significant stakes when those biotechs go public.

Another popular strategy has been to stagger, or tranche, investments to limit risk. Typically, this means firms give smaller chunks of cash early on and larger chunks later, once a startup has provided more evidence that its medicines might pan out.

And yet, despite the unprecedented challenges posed by the pandemic, venBio and others appear optimistic that a 2008-like shakeout isn't coming, and that they won't have to rely on unorthodox strategies to navigate the future. Royston's view on 2020 opportunities hasn't changed; Nelsen doesn't foresee the pandemic preventing Arch from investing right now; and Flagship is still on track to spin around 10 projects into full companies over the next year and a half, Afeyan said.

There's a key difference this time around, several firms and advisors said, and that's the money which has so far stayed readily available to healthcare investors. Cowen Healthcare Investments just last week finished raising nearly half a billion dollars, adding to the string of recent hauls from other firms.

"We've seen these things come and go, and frankly we've done some of our best companies in the down cycles," Nelsen said.

A pandemic, however, isn't just another down cycle.

Past downturns didn't threaten to overwhelm the healthcare system, as the outbreak of the coronavirus has. Hundreds of thousands of Americans have been sickened by coronavirus infections. And for millions of people with diseases other than COVID-19, how they seek and receive care changed overnight.

The widespread shutdown of businesses across the country, meanwhile, has created economic hardship not seen since the Great Depression, and it's unlikely a stop-and-start reopening will quickly heal those wounds.

"No one fully can comprehend, even in a world as smart as the biotech scientific world, the trajectory and the impact of the current situation," said Amy Schulman, a managing partner at Polaris.

Whether the pandemic persists into next year or lingers much longer, venture capitalists do acknowledge it will have profound effects on society and, by extension, the drug industry.

Nashat envisions that "new kinds of entrepreneurs" will rise amid the chaos, while others will be "scared off." Nelsen predicts big changes in how healthcare is delivered, which will "shock" the system and create new opportunities.

That means investors will need to adapt too.

"It would be incredible, to me," Afeyan said, "if people just forgot this and resumed their old normal."

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COVID-19: How many strains of the new coronavirus are there? – Medical News Today

Wednesday, May 27th, 2020

Since the emergence of the new coronavirus, called SARS-CoV-2, several researchers have proposed that there is more than one strain, and that mutations have led to changes in how infectious and deadly it is. However, opinions are divided.

Genetic mutations are a natural, everyday phenomenon. They can occur every time genetic material is copied.

When a virus replicates inside the cell it has infected, the myriad of new copies will have small differences. Why is this important?

When mutations lead to changes in how a virus behaves, it can have significant consequences. These do not necessarily have to be detrimental to the host, but in the case of vaccines or drugs that target specified viral proteins, mutations may weaken these interactions.

Since the emergence of SARS-CoV-2, several research studies have highlighted variations in the viruss genetic sequence. This has prompted discussion about whether or not there are several strains, if this has an impact on how easily the virus can infect a host, and whether or not this affects how many more people are likely to die.

Many scientists have called for caution. In this Special Feature, we summarize what researchers currently know about SARS-CoV-2 mutations and hear from experts about their views on what these mean for the pandemic.

SARS-CoV-2 is an enveloped RNA virus, which means that its genetic material is encoded in single-stranded RNA. Inside a host cell, it makes its own replication machinery.

RNA viruses have exceptionally high mutations rates because their replications enzymes are prone to errors when making new virus copies.

Virologist Prof. Jonathan Stoye, a senior group leader at the Francis Crick Institute in London in the United Kingdom, told Medical News Today what makes virus mutations significant.

A mutation is a change in a genetic sequence, he said. The fact of a mutational change is not of primary importance, but the functional consequences are.

If a particular genetic alteration changes the target of a drug or antibody that acts against the virus, those viral particles with the mutation will outgrow the ones that do not have it.

A change in a protein to allow virus entry into a cell that carries very low amounts of receptor protein could also provide a growth advantage for the virus, Prof. Stoye added.

However, it should be stressed that only a fraction [of] all mutations will be advantageous; most will be neutral or harmful to the virus and will not persist.

Mutations in viruses clearly do matter, as evidenced by the need to prepare new vaccines against [the] influenza virus every year for the effective prevention of seasonal flu and the need to treat HIV-1 simultaneously with several drugs to [prevent the] emergence of resistant virus.

Prof. Jonathan Stoye

MNT recently featured a research study by a team from Arizona State University in Tempe. The paper described a mutation that mimics a similar event that occurred during the SARS epidemic in 2003.

The team studied five nasal swab samples that had a positive SARS-CoV-2 test result. They found that one of these had a deletion, which means that a part of the viral genome was missing. To be precise, 81 nucleotides in the viral genetic code were gone.

Previous research indicated that similar mutations lowered the ability of the SARS virus to replicate.

Another study, this time in the Journal of Translational Medicine, proposed that SARS-CoV-2 had picked up specific mutation patterns in distinct geographical regions.

The researchers, from the University of Maryland in Baltimore and Italian biotech company Ulisse Biomed in Trieste, analyzed eight recurrent mutations in 220 COVID-19 patient samples.

They found three of these exclusively in European samples and another three exclusively in samples from North America.

Another study, which has not yet been through the peer review process, suggests that SARS-CoV-2 mutations have made the virus more transmissible in some cases.

In the paper, Bette Korber from the Los Alamos National Laboratory in New Mexico and collaborators describe 13 mutations in the region of the viral genome that encodes the spike protein.

This protein is crucial for infection, as it helps the virus bind to the host cell.

The researchers note that one particular mutation, which changes an amino acid in the spike protein, may have originated either in China or Europe, but [began] to spread rapidly first in Europe, and then in other parts of the world, and which is now the dominant pandemic form in many countries.

Prof. Stoye commented that the results of this study are, in some ways, not surprising.

Viruses are typically finely tuned to their host species. If they jump species, e.g., from bat to human, a degree of retuning is inevitable both to avoid natural host defenses and for optimum interaction with the cells of the new host, he said.

Random mutations will occur, and the most fit viruses will come to predominate, he added. Therefore, it does not seem surprising that SARS-CoV-2 is evolving following its jump to, and spread through, the human population. Clearly, such changes are currently taking place, as evidenced by the apparent spread of the [mutation] observed by Korber [and colleagues].

However, Prof. Stoye does not think that it is clear at this point how mutations will drive the behavior of SARS-CoV-2 in the long term.

Fears about SARS-CoV-2 evolution to resist still-to-be-developed vaccines and drugs are not unreasonable, he explained. Nevertheless, it is also possible that we will see evolution to a less harmful version of the virus, as may well have occurred following initial human colonization by the so-called seasonal coronaviruses.

Earlier this year, researchers from Peking University in Beijing, China, published a paper in National Science Review describing two distinct lineages of SARS-CoV-2, which they termed S and L.

They analyzed 103 virus sequence samples and wrote that around 70% were of the L lineage.

However, a team at the Center for Virus Research at the University of Glasgow in the U.K. disagreed with the findings and published their critique of the data in the journal Virus Evolution.

Given the repercussions of these claims and the intense media coverage of these types of articles, we have examined in detail the data presented [] and show that the major conclusions of that paper cannot be substantiated, the authors write.

Prof. David Robertson, head of Viral Genomics and Bioinformatics at the Centre for Virus Research, was part of the team. MNT asked his views on the possibility of there being more than one strain of SARS-CoV-2.

Until there is some evidence of a change in virus biology, we cannot say that there are new strains of the virus. Its important to appreciate that mutations are a normal byproduct of virus replication and that most mutations we observe wont have any impact on virus biology or function, he said.

Some of the reports of, for example, amino acid changes in the spike protein are interesting, but at the moment, these are at best a hypothesis. Their potential impact is currently being tested in a number of labs.

Prof. Stoye thinks that it is more a case of semantics rather than anything else at the moment.

If we have different sequences, we have different strains. Only when we have a greater understanding of the functional consequences of the evolutionary changes observed does it make sense to reclassify the different isolates, he said.

At that point, we can seek to correlate sequence variation with prognostic or therapeutic implications. This may take a number of years.

So, what kind of evidence are skeptical scientists looking for in the debate around multiple SARS-CoV-2 strains?

MNT asked Prof. Martin Hibberd, from the London School of Hygiene and Tropical Medicine in the U.K., to weigh in on the debate.

For virologists, strain is rather a subjective word that does not always have a clear specific meaning, he commented.

More useful in the SARS-CoV-2 situation would be the idea of serotype, which is used to describe strains that can be distinguished by the human immune response an immune response to one serotype will not usually protect against a different serotype. For SARS-CoV-2, there is no conclusive evidence that this has happened yet.

To show that the virus has genetically changed sufficiently to create a different immune response, we would need to characterize the immune protection and show that it worked for one serotype and not for another, he continued.

Prof. Hibberd, who has been researching SARS-CoV-2 mutations, explained that scientists are studying neutralizing antibodies to help them define a serotype for SARS-CoV-2. These antibodies can prevent the virus from infecting a host cell, but they may not be effective against a new strain.

Several groups around the world have identified a specific mutation in the SARS-CoV-2 spike protein, and they are concerned that this mutation might alter this type of binding, but we cannot be sure it does that at the moment. More likely, this mutation will likely affect the virus binding to its receptor [], which might affect transmissibility.

Prof. Martin Hibberd

We ideally need experimental evidence, [such as a] demonstration of a mutation leading to a functional change in the virus in the first instance, and secondly a demonstration that this change will have an impact in [people with the infection], Prof. Robertson suggested.

He pointed to lessons that experts learned during the 20142018 Ebola outbreak in West Africa, where several research groups had suggested that a mutation had resulted in the virus becoming more easily passed between people and more deadly.

Cell culture experiments showed that the mutated virus was able to replicate more rapidly. However, when scientists subsequently studied this in animal models, they found that it did not behave any differently than stains without the mutation.

Scientists around the world continue to search for answers to the many outstanding questions around SARS-CoV-2. No doubt, we will see more research emerge in the coming months and years that will assess the impact of SARS-CoV-2 mutations on the COVID-19 pandemic and the future of this new coronavirus.

For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.

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More insight into the cytokine storm caused by Covid-19 could lead to a treatment – Health24

Wednesday, May 27th, 2020

The immune system response triggered by Covid-19, causing an overproduction of cytokines, has been big news during the pandemic.

While Covid-19 deaths are usually caused by acute respiratory distress syndrome (ARDS), especially in older adults and those with co-morbidities, some younger Covid-19 patients have suffered severe symptoms because of an overreaction by their immune systems, rather than the virus itself.

Now, a new clinical trial will test a treatment that targets this immune response, according to a press release from the Howard Hughes Medical Institute.

The mechanism behind the cytokine storm

According to leading immunologists in Japan, a molecular mechanism could lead to possible ways to treat this overreaction by the immune system. The research was published in the journal Immunity.

The immune system response to the coronavirus may lead to ARDS, causing patients to struggle for oxygen in their inflamed, fluid-filled lungs.

"To rescue the patients from this condition, it is vital to understand how SARS-CoV-2 triggers the cytokine storm that leads to ARDS," stated Masaaki Murakami, the head of the immunology laboratory at Hokkaido University's Institute for Genetic Medicine.

His study suggested that the novel coronavirusenters human cells by attaching to the ACE2 surface receptor. Then, a human enzyme called TMPRSS2 is utilised.

"Drugs that block the ACE2 receptor or that inhibit the enzyme could help treat the initial stages of the disease," says Murakami. "However, ARDS with cytokine storm starts to appear in the later phase of infection even when the numbers of the virus decrease. So, there must be another pathway that causes the cytokine storm, Murakami explained in a news statement.

Closer to a treatment?

The treatment that will be tested in a clinical trial by the Howard Hughes Medical Institute involves a common type of alpha-blocker. Through mouse studies, the team determined that this drug might break the hyperinflammation before it causes the severe symptoms seen in Covid-19 patients.

"The approach we're advocating involves treating people who are at high risk early in the course of the disease, when you know they're infected but before they have severe symptoms. If the trial's results suggest the drug is safe and effective against Covid-19, it could potentially help many people recover safely at home and lessen the strain on hospital resources, stated Howard Hughes Medical Investigator Bert Vogelstein.

Together with his team at the John Hopkins University School of Medicine, Vogelstein is currently recruiting patients aged 45 to 85 at the John Hopkins Hospital to participate in the trial. The prerequisites are that they have to be hospitalised, but not ventilated or in ICU.

How will an alpha blocker stop the cytokine storm?

A hyperactive immune system isnt a new response solely seen in Covid-19. Usually, this type of response is seen in people already suffering from autoimmune diseases or cancer.

What happens during a cytokine storm is that cells called macrophages, which are either found in the tissues or in the blood as white blood cells, are activated to detect and fight the pathogen. As soon as this happens, cytokines are released to help the body fight off the intruder.

Unfortunately, the macrophages dont only release cytokines, but also molecules called catecholamines, which trigger the immune system to release even more cytokines.

According to the news release, Vogelsteins team was already investigating how this reaction in cancer patients could be halted with immunotherapy.

They then looked at alpha-blockers which are usually prescribed for prostate conditions and high blood pressure. This medication is meant to help curb the cells that trigger cytokine storms.

The initial research in mice was published in the journal Nature in 2018.

How likely is this method to be successful?

While alpha-blockers were already approved for human use, Vogelsteins team needed to look at medical claims data to see how patients with pneumonia and ARDS responded to alpha-blockers for unrelated conditions.

The conclusion was that the use of alpha-blockers were correlated to lower death risk, but this simply wasnt enough evidence for a new condition such as Covid-19.

Now, the patients on trial will take increasing doses of an alpha-blocker over six days. The team will then evaluate whether those patients had lower risk of ICU admission and being placed on ventilators.

A second trial will be needed to establish whether this approach is safe and effective. According to Vogelstein, this method may be great for helping to mitigate symptoms before they become severe and deadly.

"Eventually, hopefully, a vaccine will be produced, and that will be the essence of prevention," he stated. "But until vaccines are available, secondary prevention makes a lot of sense."

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With big talk and hurled insults, the gloves come off in the race for the coronavirus vaccine – CNN

Wednesday, May 27th, 2020

While several vaccine developers have issued statements looking into the future -- setting possible timetables for study completion and vaccine manufacturing -- the ethicists and doctors say one group in particular stands out as being the most aggressive in painting the rosiest picture: the University of Oxford in England.

Oxford has recently walked back some of its optimism, but for months, it set a tone that its vaccine was the most promising, without any solid evidence that this was based in fact.

First, in a field fraught with potential failure, two Oxford researchers stated that they're "80% confident" that the vaccine will work, and that they might be able to complete large-scale clinical trials in just six weeks, a fraction of what some other vaccine companies estimate they can do.

Second, some experts have accused Oxford scientists of spinning results of their vaccine research in monkeys to make the vaccine look more powerful than it is, which Oxford denies.

Third, one leader in the Oxford team has gone so far as to denigrate other teams trying to get a Covid vaccine on the market, calling their technology "weird" and labeling it as merely "noise." Such name-calling is highly unusual and aggressive among scientists.

Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center, said he "sat straight up" when he heard one of the Oxford scientists talk about how well their vaccine is progressing.

"Some of us in the scientific community here in the US have been a little surprised at the sprightly competitiveness of some of the comments from our colleagues at Oxford. We don't usually see that in public pronouncements," said Schaffner, a longtime adviser to the US Centers for Disease Control and Prevention. "We've been grumpy with our national political leaders about providing inaccurate information, and we should hold scientific leaders to those same standards."

Dr. Paul Offit, a University of Pennsylvania pediatrician who developed a vaccine for rotavirus, agrees.

"At this point, the Oxford researchers have no idea whether they have something or not," Offit said. "You just get so tired of this 'science by press release.' "

But one of the leaders of the Oxford research team says he and his colleagues are just being straightforward.

"We're going to be first to finish," said Dr. Adrian Hill, one of the lead Oxford researchers. "How can you criticize us for giving our honest opinion?"

On April 16, CNN's Erin Burnett pressed Hill on his predictions.

"Do you have any concern that you're being overly optimistic, that that just seems, for lack of a better word, too good to be true?" Burnett asked.

"We don't think so," Hill answered.

Weeks later, Hill would have to backtrack on his own optimism, warning against "over-promising" and ratcheting down his expectations of success.

Most vaccine efforts will fail

Five Chinese companies have vaccines in human trials. Oxford is the only one in Europe. Worldwide, there are 114 more candidates in pre-clinical trial stages.

Vaccine development is a risky business. Sometimes even ones that get to large-scale clinical trials fail.

Even so, scientists from various experimental vaccine teams have made public statements about their interim results.

On May 18, Massachusetts-based Moderna put out a press release declaring that results in eight human study subjects showed that its vaccine "was generally safe and well tolerated."

Moderna CEO Stphane Bancel referred to the results as "positive interim Phase 1 data" and that "the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July."

Moderna's stock soared, and the company was criticized for announcing results on just eight study subjects when the data hadn't even been peer-reviewed or published in a scientific journal.

The Oxford scientists have voiced less caution, frequently appearing in the media and making public proclamations that theirs will likely be successful and first.

On April 11, lead researcher Sarah Gilbert told The Times of London that she was "80% confident" that the Oxford vaccine will work.

Her own colleague questioned that statement a few weeks later.

But Hill, the director of the Jenner Institute at Oxford, which specializes in vaccine development, dismissed Bell's comments.

"It's like asking me about a renal drug, asking John about a vaccine. It's not what he does. It's what Sarah does every day and has done for 25 years," Hill said.

Bell did not respond to CNN's multiple requests for comments.

On May 19, Hill told CNN he stood by Gilbert's estimate.

"We did not exaggerate anything. We're not backtracking at all from the 80%," he said.

The wisdom of Spider-Man

Inovio and Moderna have said they expect their large-scale clinical trials, known as Phase 3 trials, to last around six months. Pfizer hasn't given a timetable for its Phase 3 trial.

On May 19, Hill told CNN that his group is planning to start its Phase 3 trial sometime before July 1, and that they could finish by the end of the July, which means the trial would be between a month and six weeks long, although he thought August or September was more likely.

"I've not seen anyone wrap up a Phase 3 trial in a month to six weeks," said Dr. Saad Omer, a Yale University infectious disease expert who's done clinical trials on polio, pertussis and influenza vaccines. "We need to benchmark this against realistic expectations."

Hill said he thought it was important to benchmark his trial progress because "it has huge public policy implications" for officials who are trying to make rules about when to open up communities.

But Omer said that's exactly why it's important to be realistic about how long the vaccine development process will take.

"I buy that this is a pandemic and we may need to show progress and show steps, and I'm OK with making forecasts if decision makers want that, but do it with a level of uncertainty, because that's what's warranted," said Omer, director of the Yale Institute for Global Health.

He said the issue isn't Oxford's specific vaccine technology -- he said they were "scientifically solid" -- but rather that unexpected events can happen during a vaccine trial.

One big stumbling block for any vaccine trial is that Covid-19 infection rates in many areas of the world are flattening out or declining. The point of Phase 3 is to vaccinate people and then see if they naturally become infected, and with lower rates of circulating virus, the study subjects are less likely to be exposed to the virus in the first place.

"Just because things have gone right does not mean the next steps will go exactly on time, and won't go sideways, even if eventually we'll get there," Omer said.

That's why he encourages humility in making any projections about reaching the finish line.

"As Spider-Man says, with great power comes great responsibility, and being responsible is not projecting things with more precision than the field and the history of vaccine development suggests," he added.

Oxford scientist insults other vaccine teams

Hill, the Oxford scientist, has several arguments about why he thinks his vaccine is more promising than the others currently in human clinical trials.

First, he cites his team's many years of research on the technology used in their Covid vaccine.

The Oxford vaccine uses what's called an adenovirus vector. Adenoviruses cause the common cold, but in this case, the adenoviruses are weakened and modified to deliver genetic material that codes for a protein from the novel coronavirus. The body then produces that protein and, ideally, develops an immune response to it.

Despite all this research, none of the Oxford vaccines has made it on the market, Hill said.

Still, Hill told CNN in the May 19 interview that his vaccine, plus one in China that also uses an adenovirus vector, are "the front runners" among the vaccines in clinical trials.

Hill then proceeded to disparage other teams' vaccines -- a highly unusual and aggressive move.

The four US vaccine candidates use a different technology -- or vaccine "platform" -- than Oxford.

Two of them, Moderna and Pfizer, use RNA vaccines, which inject a piece of genetic material from the novel coronavirus into human cells to stimulate immunity.

Hill described RNA vaccines as merely "noise from the new boys."

A Harvard University blog describes it differently.

Hill was particularly disparaging of Moderna, which he said has "weird and wonderful technology." When asked what he meant by "wonderful," Hill said, "I was being sarcastic."

"They've got an unproven technology," he said.

CNN asked Moderna for its response, as well as Pfizer.

"Our only competitors in this race are the virus and the clock. We are rooting for multiple vaccines to succeed because we believe no manufacturer can make enough doses for the planet," according to the Moderna statement.

"Our industry peers, the other pharmaceutical and biotechnology companies as well as health authorities, have come together like never before. We're acutely aware that we are all on the same side, and COVID-19 and other diseases are the enemy," Pfizer spokeswoman Amy Rose wrote in an email to CNN.

Hill also took a jab at Inovio, a US vaccine maker in clinical trials, saying "they can't scale up to get into phase three," clinical trials.

Inovio's technology uses a brief electrical pulse to deliver plasmids, or small pieces of genetic information, into human cells. Inovio says those cells then produce the vaccine, which leads to an immune response.

Jeff Richardson, a spokesman for the company said that "our competition is the virus, not other companies. There needs to be three or four winners to vaccinate the world. Most likely, there will be a number of vaccines that make it, and that's a good thing."

As for the four Chinese companies in clinical trials with a potential Covid vaccine, Hill said "they have a problem."

For a vaccine clinical trial to be successful, there needs to be sufficiently high levels of the virus circulating in the community. If there isn't enough virus around, it will be impossible to tell if the vaccine protected the study subjects, or if they were just never exposed to the virus.

"There's no Covid left in China. They can't finish," Hill said.

There is still a bit of Covid left in China, with a few dozen cases left, according to the latest briefings by the nation's National Health Commission. While this is likely not enough for a full-scale clinical trial, the researchers could conduct trials in other countries where the vaccine is still circulating more widely.

Oxford not in 'slam dunk' territory

The Oxford scientists have sometimes tempered their positive statements with more cautious ones.

"Nobody can be absolutely sure it's possible. That's why we have to do trials. We have to find out. I think the prospects are very good, but it's clearly not completely certain," Gilbert answered.

But the US and British media have focused more on the positive statements, often writing glowing reports about the vaccine's progress.

A few weeks ago, a headline in a US newspaper story proclaimed that the "Oxford group leaps ahead" even though it's not clear there's a single front runner among the vaccines.

"Should be careful when talking about #COVID19 vaccine progress. As a vaccine researcher, I am cautiously optimistic; but we must be mindful of projecting too much confidence. We are not in slam dunk territory," he wrote.

Oxford's monkeys, in particular, have received attention.

BioRxiv.org is a pre-print server, meaning the articles have not been reviewed by other scientists and have not been published in the medical literature.

After the monkeys were vaccinated and then exposed to the virus, they were euthanized and examined for lung damage. According to the Oxford study, none of the vaccinated animals had signs of pneumonia or other lung problems, but two out of three unvaccinated monkeys did develop some degree of viral pneumonia.

"We were very excited by seeing that in the first try," he added.

But William Haseltine, a virologist and former professor at Harvard Medical School, said Hill was being "misleading."

"In this interview Hill is like a magician who distracts the audience with one shiny object to detract you from the fact that his accomplice is picking your pocket," Haseltine told CNN in an email.

Also, he said the monkeys had just as much viral RNA in their nasal secretions compared to the unvaccinated monkeys, an indication to him that the vaccine didn't work and the monkeys could possibly spread the virus to others.

Thirdly, Haseltine pointed to neutralizing antibodies. A vaccine should elicit high levels of antibodies capable of disabling the virus and preventing it from infecting human cells. Haseltine said the level of these antibodies in the monkeys who received the Oxford vaccine was "extremely low."

Haseltine told CNN that the monkey study on the Oxford vaccine was an "outright failure."

The Oxford scientists quickly wrote a statement rebutting Haseltine's article. They had been given the novel coronavirus directly into their noses -- called an intranasal challenge -- and so the presence of virus in the nasal swabs "may reflect use of a very high intranasal challenge dose greater than that transmitted in natural infections," according to the statement.

They also wrote that there were neutralizing antibodies present in all the monkeys who were vaccinated, but not in the unvaccinated monkeys.

"The comment by Haseltine appears to misunderstand the impressive efficacy of the [Oxford] vaccine in the non-human primate model," according to the statement.

Offit, the co-inventor of the rotavirus vaccine, said he thinks it's not a deal breaker that the vaccinated monkeys got infected. People sometimes still get the flu when they get a flu vaccine, but they often get only mild symptoms. Children still can get rotavirus after getting his vaccine, but again, typically a milder version that's less life-threatening.

He said the fact that the monkeys did not develop pneumonia after receiving the Oxford vaccine is "encouraging," but he was not convinced that the Oxford vaccine would ultimately work, since vaccines that show signs of success in animals sometimes fail in humans.

"As vaccine researchers like to say, mice lie and monkeys exaggerate," Offit said.

Offit and others say they sometimes cringe when they hear Oxford scientists talk about their vaccine.

Bioethicist Alta Charo said sometimes scientists can become "overly optimistic" about their work, especially as they race to put an end to the pandemic.

"It is very easy to get caught up in the potential of a new medical product when early development and testing seem to show promise. It is very easy to believe in your own work," said Charo, a professor at the University of Wisconsin Law School.

Art Caplan, a bioethicist at NYU Langone Health and CNN medical analyst, said it's especially important to be circumspect about vaccines, since so many people have lost trust in vaccines and are hesitant to vaccinate their children, or downright refuse to do so.

"The world is watching, and if you're puffing something up that's uncertain, that's really troubling," he said.

On Saturday, after months of rosy predictions, Hill deflated his predictions of success considerably and softened his competitive tone.

In that interview, Hill warned against "over-promising" and said that developing a vaccine is "not a race against the other guys. It's a race against the virus disappearing, and against time."

Offit said this was much more realistic.

"This tells you he's starting to back away from his original statements, as he's noticed the impracticality of his original statements," he said.

Offit has some advice for Covid vaccine developers: Be quiet.

"Now researchers can't wait to step out to the microphone -- and there are so many microphones out there -- to say, 'I've got it! This looks really good!' " Offit said.

When he and his team were developing the RotaTeq vaccine, he said they didn't speak to the media until they received final approval from the US Food and Drug Administration in 2006.

Today that vaccine saves hundreds of lives a day worldwide, Offit said, mostly children under the age of 2.

"When we discovered our rotavirus vaccine was safe in mice, we didn't say anything. When we finished our Phase one clinical trials, we didn't say anything. We just moved forward," he said.

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Questions about COVID-19 test accuracy raised across the testing spectrum – NBC News

Wednesday, May 27th, 2020

For Sarah Bowen, it all started with a sore throat. Not the kind of searing pain shed feel with strep, she said, but a throat irritation that just didnt feel right.

By the end of the day, it just got a little worse and I didnt feel great. I felt like I might be coming down with something. And the next day, things got worse, Bowen, 31, of Portland, Oregon, said.

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Bowen works at a doctors office, where she was immediately able to get tested for COVID-19, on May 8. It came back negative, and her doctor said the symptoms were most likely allergies or another virus.

But from there, things snowballed. Bowen developed headaches, a stuffy nose, hot flash symptoms and constant headaches. By day six, she felt like she was hit by a truck. She had extreme fatigue and a burning sensation in her chest.

I started getting shortness of breath if I went upstairs to get water or something, Bowen said. It got worse when I moved around.

Two days later, she took another test for COVID. Again, it came back negative.

But despite her symptoms, her doctor didnt believe she had the virus, because there werent many cases in the Portland suburb where she lives. Frustrated, Bowen continued to isolate alone in the downstairs of her home. She didnt want to take any chances.

Its one thing to get sick and know its a cold or the flu. But to get sick during a pandemic and to be kind of dismissed, makes you feel crazy, she said.

Bowens diagnosis remains unclear, but her experience raises questions about the accuracy of diagnostic tests for the disease. Indeed, as more and more people have access to testing, new data show that false negatives on COVID-19 tests may be more common than first realized.

And as the U.S. starts to reopen, accurate testing is one of the most important tools in states' arsenals to track and stop the spread of the coronavirus.

Since the pandemic started spreading across the United States in March, nearly 70 tests have received emergency use authorization from the Food and Drug Administration. Many of these tests were developed at a breakneck pace in an effort to get tests out to the American people.

But while no test is perfect, experts told NBC News that these particular tests used to diagnose COVID-19 may be missing up to 20 percent of positive cases.

One key reason behind these so-called false negatives may be how the testing samples are collected.

The false negatives are mainly due to specimen acquisition, not the testing per se, said Dr. Alan Wells, medical director for the University of Pittsburgh Medical Center clinical laboratories and a professor of pathology at the University of Pittsburgh.

Most tests use a method called polymerase chain reaction or PCR. It detects coronavirus genetic material thats present when the virus is active. Clinicians typically collect a sample for testing from the back of a persons throat where the virus is presumed to be with a long nasopharyngeal swab.

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But scientists say that collection method is ripe for error.

Youre sampling blindly. Youre hoping you get the right spot. Then as the disease progresses, the virus might migrate down into your lungs, Wells said, adding that once its in the lungs, that nasopharyngeal swab may not pick up any virus if its already been cleared from the throat.

You have to be at the right place at the right time, he said.

Another type of diagnostic test forgoes the uncomfortable swab altogether, and instead uses saliva collected in a test tube. Once the sample arrives in the lab, its tested the same way, with PCR.

But Wells said those tests could fare even worse.

The reason for pharyngeal swabs is the virus preferentially infects and replicates starting way back in the inner cavities of the nose and not out in front, where it may come into contact with saliva, he said, adding that saliva tests could end up missing up to 50 percent of asymptomatic positive cases.

Making things even more complicated, a May 13 study in Annals of Internal Medicine, from researchers at the Johns Hopkins Bloomberg School of Public Health in Baltimore, found that test timing is also essential to getting an accurate result.

Lead study author Dr. Lauren Kucirka, a medical resident at Johns Hopkins Medicine, said testing too early after exposure to the virus substantially raises the risk of a false negative.

If you have someone who has been exposed and theyve started to develop symptoms, it probably makes sense to wait a few days before testing, Kucirka told NBC News.

Her study found that three days after the onset of symptoms is when the test is most likely valid.

But besides issues with how and when test samples are collected, questions are also being raised about the quality of the diagnostic tests themselves.

The biggest problem with that is you create a false sense of security.

In other words, even if samples are collected perfectly, at the ideal time, the tests could turn up incorrect results. A commentary published in April in Mayo Clinic Proceedings criticized the reliance on PCR tests, saying that even when tests are 90 percent accurate, that still leaves a substantial number of false test results.

The articles co-author, Dr. Priya Sampathkumar, an infectious disease specialist at the Mayo Clinic, used California as an example in a statement: If the entire population of 40 million people were tested, there would be 2 million false negative results. Even if only 1 percent of the population was tested, there would be 20,000 false negatives.

The biggest problem with that is you create a false sense of security, Wells said.

Another type of COVID-19 diagnostic test, Abbott Labs popular ID NOW point-of-care test, has also come under fire in recent weeks, after the FDA issued an alert that it may not always be accurate.

The test, which uses a method different from PCR, called isothermal nucleic acid amplification, can deliver results in five to 13 minutes. Its used by doctors across the country and touted by the White House as whats used to test President Donald Trump and other staffers.

One small study by NYU Langone Health found that the test returned false negatives for nearly 50 percent of certain samples that a rival test had found to be positive. The study has not yet been peer-reviewed.

In response, Abbott last week released interim data on several of its own studiesfinding that accuracy was significantly better, in some cases nearly 100 percent, especially when performed in patients who were tested early after their onset of symptoms.

But anecdotal reports have also found issues with accuracy, leading some of the nations largest medical centers to stop or never even start using it.

NBC News spoke with 10 medical centers and hospitals across the country; seven said they werent using the Abbott test.

All seven cited issues with accuracy, including Jackson Memorial Hospital System in Miami, which said in a statement that they identified some issues with the accuracy, which is to be expected when the medical science is so new and evolving so quickly around this virus. The best fit for Jackson was to transition to other testing platforms that have high-quality accuracy rates and quick turnaround times for results.

A Vanderbilt University Medical Center spokesman told NBC News that No patient at Vanderbilt University Medical Center has been tested via the Abbott ID NOW rapid test. Here, there were concerns about the sensitivity of that test.

Some hospitals continuing to use the Abbott test, such as Sutter Health Hospitals in California, said they often will confirm any negative results with another PCR test if there is clinical suspicion of COVID-19.

Abbott told NBC News in a statement that to date, the company has delivered more than 2 million tests to all 50 states.

"Our customers are telling us that theyre seeing positivity rates from ID NOW testing at or above local community infection rates, which means that ID NOW is detecting the virus at the same level as lab-based testing," the statement said in part. "If there were any systemic problem with ID NOW producing false negatives, that wouldnt be the case."

The bigger issue may be that test manufacturers just havent caught up to science. Its not just COVID-19 tests that have issues with accuracy. In fact, diagnostic tests for all sorts of common diseases are not even close to perfect.

Take rapid strep throat tests, for instance. According to a Cochrane Review, those tests have a sensitivity of just 86 percent. The Centers for Disease Control and Prevention says rapid flu tests are even worse, with a sensitivity ranging from 50 to 70 percent.

Rapid strep and rapid flu tests look for antigens proteins made by the infectious pathogen rather than genetic material. The first antigen test for COVID-19 received an emergency use authorization from the FDA earlier this month, but questions have already been raised about its accuracy.

Taken together, its why Dr. Ania Wajnberg, associate director of medicine at the Icahn School of Medicine at Mount Sinai, said that diagnostic tests need to be put together with clinical suspicion.

We still have a lot to learn, but testing itself is hugely important, Wajnberg said. If its not perfect, it doesnt mean its not useful.

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The Time of Trials: Waiting for a Coronavirus Vaccine – Discover Magazine

Wednesday, May 27th, 2020

The Covid-19 coronavirus has knocked our world off its axis. We wont return to anything approaching normal that is, life without social distancing, quarantines, masks, school closures and other control measures until most of the world has been vaccinated against the virus. Everyone, therefore, has the same question on their mind: How fast will a vaccine be ready?

The history of vaccine development is not encouraging. Ive been working on vaccines for a long time, says Barney Graham, deputy director of the Vaccine Research Center at the US National Institute of Allergy and Infectious Diseases. Ive never seen one take less than about 20 years. It took 26 years to develop a vaccine for the human papilloma virus, for instance, and 25 years to secure one for rotavirus. And researchers have been trying for more than 50 years to find a vaccine against respiratory syncytial virus, one of the leading causes of infectious disease mortality in infants. Even after Grahams group figured out a better approach in 2013, the vaccine is still only in the testing phase.

These are not normal times, however, and a vaccine for the Covid-19 virus, formally known as SARS-CoV-2, is the focus of unprecedented research efforts. Already, over 100 research groups have vaccine candidates under development, and a few are already being tested in people. In mid-May, the US government announced Operation Warp Speed, an initiative that aims to have a vaccine ready for general use by the end of 2020.

Almost all experts say that target is too optimistic, generally citing the spring of 2021 as a best-case scenario. But to hit even that later target, a lot of things have to break right, and a lot of logistic hurdles have to be cleared away. Heres a look at some of the key issues in vaccine development.

All vaccines aim for the same goal: exposing the bodys immune system to protein or carbohydrate fragments, or antigens, displayed by a virus or other pathogen. If all goes as planned, memory cells within the immune system remember this introduction. If the vaccinated person is later exposed to the actual virus, these cells enable the immune system to react quickly, suppressing the disease or reducing its severity.

Where vaccines differ is in how they present those antigens. Some vaccines, such as ones against measles and polio, use the entire virus that has been either killed or damaged so that it no longer causes disease. Because these vaccines use the whole virus, researchers dont need to know as much about the virus and its proteins. But because a whole virus offers many antigens to the immune system and because of the slight risk that a live virus could become pathogenic again more can go wrong. So whole-virus vaccines need extensive safety testing, a process that can take years.

Other vaccines extract the viral gene that codes for the desired antigen and insert it into another, less harmful virus that is then delivered to the patient (the recently approved vaccine for Ebola is a case in point). Still others use bacteria or yeast to manufacture the antigen in fermentation vats. The antigen can then be injected directly, as in the hepatitis B vaccine, or used to build empty shells of viruses that lack genetic material, as in the vaccine against human papilloma virus.

Newer, more experimental vaccines are on the table too. They deliver not the antigen itself but the genetic material that codes for it, either as RNA or DNA, usually encapsulated in a fatty membrane. This enters the bodys cells and directs them to make the relevant protein themselves to trigger the immune response. Such vaccines could be quicker to create because genetic material is easier to mass-produce than proteins are. But RNA and DNA vaccines are so new that none have yet been approved for use by the general public.

Before a vaccine is ready for public use, researchers must prove to government regulators that it is both effective and safe to use. That takes time.

Like all medicines, after vaccines are tested in experimental animals, they go through three phases of testing in people. First, a few healthy volunteers receive the vaccine: This Phase 1 trial tests for safety and gives a rough idea of how much vaccine is needed. After that, researchers work out dosing and safety in more detail in a somewhat larger group the Phase 2 trial.

These preliminaries can be dealt with in a few months, if all goes well. But before a vaccine can be approved for general use, it must be given to a much larger group and compared with an unvaccinated control group, to see whether it really prevents disease. This Phase 3 trial is the most time-consuming step in testing, because researchers have to wait for enough participants to be exposed to a virus naturally. You cannot compress time when youre relying on a natural exposure to occur, says Michael Yeaman, an infectious disease specialist at UCLA and coauthor of a 2017 overview on vaccines in the Annual Review of Pharmacology and Toxicology.

Building manufacturing capacity also takes time. Vaccines for clinical trials are generally made in small batches in pilot facilities that arent capable of producing commercial quantities. But because very few candidate vaccines make it through clinical trials successfully Graham puts the number at less than 10 percent manufacturers are understandably reluctant to invest in large-scale production facilities until they know the vaccine will work. This adds an additional time lag to the vaccine-development process.

As of May 18, 2020, there were 169 Covid-19 vaccines under development, using a wide range of approaches. Heres a breakdown of those efforts. Columns indicate how far along each vaccine is: Preclinical means the vaccine is not yet ready for testing in people. Phase 1, 2 and 3 refer to the three phases of clinical trials in people (see text for more detail). Rows indicate type of vaccine: Live attenuated virus vaccines use live SARS-CoV-2 that has been weakened so it no longer causes disease; Inactivated virus vaccines use SARS-CoV-2 that is no longer viable. Viral vector vaccines put genes for SARS-CoV-2 antigens into another, nonpathogenic virus. Protein subunit vaccines use the antigens only, either injected directly or formed into empty protein shells. RNA and DNA vaccines are the newest kind. They deliver genetic material that codes for SARS-CoV-2 antigens, which the recipients cells use to make antigen. Note that most vaccine candidates are still in the earliest stages of development and none have yet entered Phase 3 trials, the most time-consuming step.

With Covid-19, scientists already have a big head start, because this isnt the first coronavirus theyve tried to make a vaccine for. They had begun making vaccines for SARS and MERS during their outbreaks in 2003 and 2012, respectively, only to abandon the efforts when the outbreaks receded.

So when Covid-19 came along, researchers already knew a good target for a vaccine: the spike protein that sits on the surface of the virus, and especially the part that binds to human cells, enabling the virus to gain entry. Researchers even knew how to stabilize that key part of the spike protein so it holds its shape during vaccine production.

This advance knowledge enabled the biotech company Moderna, in collaboration with the US governments Vaccine Research Center, to decide on a vaccine candidate within three days of the Covid-19 genome being sequenced. Thats nearly a year quicker than it took to find a candidate for a SARS vaccine in 2003-04.

Ideally, a steady stream of vaccine candidates should be entering clinical trials, so that each new trial can learn from its predecessors. If Im coming behind, I can design my studies better so I dont make the same mistakes, says Maria Elena Bottazzi, a vaccinologist at Baylor College of Medicine in Houston and coauthor of an article about vaccines for developing countries in the Annual Review of Medicine.

Graham is hopeful that vaccine developers can also speed through the time-consuming, large-scale Phase 3 trials by riding the wave of new Covid-19 infections that is widely expected this fall. By testing the vaccine in locations where large outbreaks are already occurring, researchers should be able to tell more quickly whether it really works.

Once testing shows that a vaccine candidate is safe and effective, regulators are likely to expedite its approval. Everyone recognizes that this is a crisis, including the regulatory authorities. In this case, the benefit of having a vaccine earlier is very high, Graham says. But that should not mean cutting corners on safety testing, he adds. We have to be cautious, even though we have to go fast. I think we can do those things together if we pay attention.

Its unwise to pin too much hope on any given vaccine, because most candidate vaccines Graham puts the number at more than 90 percent fail during their clinical trials, usually at early stages. Thats why its essential to have many potential vaccines to test. Youve got to try multiple shots on goal, and some of them will work, Yeaman says.

One big reason why vaccines fail is that they lead to the wrong kind of immune response. Theres a big difference between an immune response and a protective immune response, Yeaman says. To be effective, a vaccine must do more than merely provoke the body to make antibodies. Those antibodies must also be able to neutralize the virus so it can no longer invade host cells. A good vaccine should also prompt the right sort of activity from the bodys T cells, the part of the immune system thats responsible for orchestrating the bodys immune response to the virus. Vaccines that do these things well in lab animals often disappoint in human trials, and only testing can weed out these failures.

Sometimes, vaccines can even make a disease worse. Two different processes can cause this. In one, certain types of antibodies induced by the vaccine can help the virus more easily invade a host cell. They do so by attaching both to the virus and to a receptor for antibodies on the cell surface, serving as a bridge between the two.

In the other process, the vaccine primes the immune system too vigorously, so that an infection by the virus later on provokes an immune overreaction a cytokine storm that can prove lethal.

Both of these problems have been reported in the past with animal studies of coronavirus vaccines, including vaccines that were being developed for SARS and MERS. But there is as yet no indication that people would react in the same way. I dont think the risk is extremely high not as much as the risk of not having a vaccine and having the kind of mortality were going to have if everyone becomes infected with this virus, Graham says.

Its possible, but unlikely. There are a few viruses out there that have stubbornly resisted all efforts to develop a vaccine, including hepatitis C, herpes simplex and HIV. But many of these viruses have special features that help the virus evade a vaccine. There is no indication that the virus causing Covid-19 has any such features, Yeaman says.

On the positive side, veterinary researchers have successfully developed vaccines for other coronaviruses that infect livestock. And earlier attempts to develop vaccines for SARS and MERS both closely related to the Covid-19 virus showed promising initial results before those diseases receded and the vaccine programs were abandoned. Were hopeful that this virus is going to be amenable to vaccine, Graham says.

Indeed, in mid-May, Grahams group, working with Moderna, reported that eight healthy volunteers who received their candidate Covid-19 RNA vaccine developed a protective antibody response. (Much testing remains to be done, of course. It is still unknown whether the antibody response actually prevents disease, and Moderna has yet to share its full results.) Also in May, other researchers reported a promising T-cell response in patients who had recovered from Covid-19. Taken together, these results suggest that a vaccine is likely to succeed, Yeaman says.

Its still better than nothing. Some existing vaccines flu is a good example are useful even though vaccinated people still sometimes get sick, because they reduce the incidence of severe illness and death, Bottazzi says. Its also possible that a partially effective vaccine, in combination with a partially effective antiviral drug, could add up to nearly full protection, Yeaman points out.

Not yet. Even at the point when manufacturers are producing vast quantities of a vaccine, the job isnt done. A vaccine is not just going to magically appear in peoples homes, says Bruce Y. Lee, a vaccine logistics expert at the City University of New York. Coming up with a clear distribution and implementation plan is very important and its challenging.

Lee studies the supply chain for vaccines that is, the intermediary steps needed to deliver vaccines from the manufacturer to the point of vaccination. This chain can involve many layers. During the 2009 influenza pandemic, for example, vaccine manufacturers shipped to central hubs, which then delivered to individual states, and those state governments distributed the doses more locally. The system was plagued by mismatches between supply and demand, with far too little vaccine early on, and too much later.

At every step, this distribution process requires people, space and often refrigeration, because many vaccines are unstable at room temperature. A sudden surge of hundreds of millions, or even billions, of Covid-19 vaccine doses is likely to overwhelm the system, especially in lower-income countries where adequate refrigeration is already an issue. The existing supply chains are not ready for this, Lee says.

Even if vaccine production ramps up gradually, the supply chain will need to ensure that the vaccine initially goes to those in greatest need, such as health care workers, the elderly and others at higher risk. Health officials may also want to integrate vaccination with testing, Lee suggests, so that scarce vaccines do not go to people who have already had Covid-19.

Even something as simple as the size of vials for the vaccine and their packaging can make a huge difference in ease of delivery. Packaging for a rotavirus vaccine distributed in the early 2000s, for example, was so bulky that it clogged supply chains in Latin America and slowed distribution of all vaccines until manufacturers reformulated to allow smaller packaging, Lee says.

The problem gets even harder if the Covid-19 vaccine, like some existing vaccines, turns out to require two doses. Not only would that double the number of doses to be shipped, but front-line workers would need to do careful tracking to ensure that each recipient got exactly two doses, with the proper interval between them.

These logistical issues need attention now, not when the vaccine is ready, Lee says. Indeed, supply chain requirements might even affect which candidate vaccines we choose to pursue. A single-dose, unrefrigerated vaccine, for example, would be much preferable to a two-dose vaccine with strict refrigeration needs. This has to be looked at as a whole-system issue, Lee says.

In a sense, the world caught a break with Covid-19. We were lucky, in this case, that this was a coronavirus, because we sort of knew how to make an antigen, Graham said in an online lecture in April.

We might not be so lucky next time and there will be a next time.

To have the best chance of developing a vaccine quickly, experts should start now to develop at least one prototype vaccine for each virus family known to infect people, Graham says. (So far, thats only been done for about half of the roughly two dozen families.) That way, whatever virus emerges next, vaccine developers will have a known starting point, as they did with the Covid-19 virus. The more information you can have ahead of time, the better off youre going to be in responding, Graham says.

New vaccine technologies, such as RNA vaccines, would allow authorities to build vaccine factories that could quickly adapt to produce new vaccines, since the same production line could copy any RNA sequence, whereas producing proteins or whole viruses requires more bespoke production. This would eliminate the need for new construction. Such vaccines could also be made in smaller, more decentralized factories, which could ease supply-chain problems.

This time around, we probably wont have a vaccine until next spring at the earliest, or perhaps the fall of 2021. Eighteen months may seem like a long time to wait, but its worth remembering that if scientists hit that optimistic target, they will have developed a vaccine far faster than its ever been done before.

Bob Holmesis a science writer based in Edmonton, Canada. This article originally appeared inKnowable Magazine, an independent journalistic endeavor fromAnnual Reviews. Read the original storyhere.

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$5 million supports research into neglected tropical diseases Washington University School of Medicine in St. Louis – Washington University School of…

Friday, May 22nd, 2020

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Grants fund studies of parasitic infections affecting millions worldwide

Makedonka Mitreva, PhD, (right) works with Hyeim Jung, a doctoral student in her lab at Washington University School of Medicine in St. Louis. Mitreva has received two grants totaling $5 million to develop genomic tools to study two types of parasitic infection that are endemic in Peru and parts of sub-Saharan Africa. The research could help fight drug-resistant parasitic infections and build maps to track drug-resistant parasites.

Researchers at Washington University School of Medicine in St. Louis have received two grants from the National Institutes of Health (NIH) totaling more than $5 million to study two types of parasitic worm infection that cause devastating illness in millions of people worldwide.

The two infections are on the World Health Organizations (WHO) list of neglected tropical diseases, a group of about 20 illnesses that together affect more than 1 billion people. One project will focus on onchocerciasis, commonly known as river blindness, caused by a parasitic roundworm spread by black flies that live and reproduce near rivers. The second project will target fascioliasis, caused by a foodborne parasitic flatworm commonly found in cattle-farming operations.

Led by Makedonka Mitreva, PhD, a professor of medicine and of genetics, both projects involve large-scale genome sequencing of the parasites to develop genetic tools to help monitor the infections spread and track resistance these parasites already have developed against drugs intended to eradicate them. The genomic information also could lead to new therapies to combat the drug-resistant strains.

These parasites are becoming very good at evading the drugs that target them, and we have no idea how they are doing that, said Mitreva, also a research member of the McDonnell Genome Institute at Washington University School of Medicine. We need a better understanding of these parasites genomes so we can discover how they resist standard drugs. That knowledge then could result in identification of genetic markers that predict whether a drug will fail to effectively treat infected individuals, thus guiding the design of new treatments.

In collaboration with Miguel Cabada, MD, of the University of Texas in Galveston, Mitreva is studying fascioliasis in the highlands of Peru, where farmers and their families are often in close contact with infected livestock. Cabada, who also runs a clinic in Cusco, Peru, treats adults and children with fascioliasis infection, caused by the flatworm Fasciola hepatica. A drug called triclabendazole is the first-line treatment for fascioliasis, but resistance to the treatment is widespread in livestock and a growing problem among people who become infected.

This parasite burrows through the intestinal wall and makes its way to the liver and bile ducts, Mitreva said. It causes substantial liver damage. This sets up a long-term, chronic infection that can really have an impact on nutritional status, leading to anemia and weight loss.

Children are especially vulnerable to fascioliasis infections, which can contribute to malnutrition and lifelong consequences, including stunted growth, dysfunctional brain development and impaired immune systems. In the Andes Mountains of Peru and Bolivia, an estimated 70% of children are infected.

The researchers will sequence the genomes of fascioliasis parasites that are sensitive and resistant to triclabendazole in an effort to identify genetic reasons for the resistance and to develop a quick test to distinguish between drug-susceptible and drug-resistant worms.

In collaboration with Warwick Grant, PhD, of La Trobe University in Melbourne, Australia, Mitreva is studying river blindness in parts of sub-Saharan Africa. River blindness is caused by the parasitic roundworm Onchocerca volvulus, which is spread by black flies.

This roundworm can make its way to the eye and cause permanent blindness in some people, Mitreva said. The parasites migrate through the skin, causing nodules and extreme itching. Not all strains of the worm cause blindness that can depend on the geographic area that the worm comes from.

The drug ivermectin has been used to treat and prevent river blindness for decades. It is often given to entire communities as part of mass drug-administration programs to prevent the disease in areas where the parasite has a long history of being endemic.

We need better diagnostic tools to understand which strains dont respond well to ivermectin, identify where those strains are and develop maps of infection patterns, Mitreva said. We would like to develop ways to predict areas where the parasites are most likely to recur and, in contrast, areas where the disease is likely to be well controlled and public health officials can safely stop the long-running, mass drug-administration programs.

Being able to stop giving these drugs to entire communities may lift some of the evolutionary pressure that drives the development of drug resistance, according to the researchers. The tools they aim to develop will be suitable for genetic epidemiology. For example, should the parasite return after mass drug administration, such tools would allow the researchers to trace the likely source of the recurrence.

While these two parasites are very different in how they are spread and in the specific damage they cause, the human populations they affect overlap considerably, Mitreva said. We hope our projects can help understand these parasites better, so we can make meaningful contributions to reducing the devastating burden they place on so many people in developing countries worldwide.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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UBC scientist identifies a gene that controls thinness – UBC Faculty of Medicine – UBC Faculty of Medicine

Friday, May 22nd, 2020

Why can some people eat as much as they want, and still stay thin?

In a study published today in the journal Cell, Life Sciences Institute Director Dr. Josef Penninger and a team of international colleagues report their discovery that a gene called ALK (Anaplastic Lymphoma Kinase) plays a role in resisting weight gain.

We all know these people, who can eat whatever they want, they dont exercise, but they just dont gain weight. They make up around one per cent of the population, says senior author Penninger, professor in the Faculty of Medicines department of medical genetics and a Canada 150 research chair.

Dr. Josef Penninger

We wanted to understand why, adds Penninger. Most researchers study obesity and the genetics of obesity. We just turned it around and studied thinness, thereby starting a new field of research.

Using biobank data from Estonia, Penningers team, including researchers from Switzerland, Austria, and Australia, compared the genetic makeup and clinical profiles of 47,102 healthy thin, and normal-weight individuals aged 20-44. Among the genetic variations the team discovered in the thin group was a mutation in the ALK gene.

ALKs role in human physiology has been largely unclear. The gene is known to mutate frequently in several types of cancer, and has been identified as a driver of tumour development.

Our work reveals that ALK acts in the brain, where it regulates metabolism by integrating and controlling energy expenditure, says Michael Orthofer, the studys lead author and a postdoctoral fellow at the Institute of Molecular Biology in Vienna.

When Penningers team deleted the ALK gene in flies and mice, both were resistant to diet-induced obesity. Despite consuming the same diet and having the same activity level, mice without ALK weighed less and had less body fat.

As ALK is highly expressed in the brain, its potential role in weight gain resistance make it an attractive mark for scientists developing therapeutics for obesity.

The team will next focus on understanding how neurons that express ALK regulate the brain at a molecular level, and determining how ALK balances metabolism to promote thinness. Validating the results in additional, more diverse human population studies will also be important.

Its possible that we could reduce ALK function to see if we did stay skinny, says Penninger. ALK inhibitors are used in cancer treatments already, so we know that ALK can be targeted therapeutically.

The study was supported by the Estonian Research Council, the European Union Horizon 2020 fund, and European Regional Development Fund, the von Zastrow Foundation, and the Canada 150 Research Chairs Program.

Excerpt from:
UBC scientist identifies a gene that controls thinness - UBC Faculty of Medicine - UBC Faculty of Medicine

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Coronavirus Vaccine Trials Have Delivered Their First Results–But Their Promise Is Still Unclear – Scientific American

Friday, May 22nd, 2020

As coronavirus vaccines hurtle through development, scientists are getting their first look at data that hint at how welldifferent vaccines are likely to work. The picture, so far, is murky.

On May 18, US biotech firm Moderna revealed the first data from a human trial: its COVID-19 vaccine triggered an immune response in people, and protected mice from lung infections with the coronavirus SARS-CoV-2. The results which the company, based in Cambridge, Massachusetts, announced in apress release were widely interpreted as positive and sent stock prices surging. But some scientists say that because the data havent been published, they lack the details needed to properly evaluate those claims.

Tests of other fast-tracked vaccines show that they have prevented infections in the lungs of monkeys exposed to SARS-CoV-2 but not in some other parts of the body. One a vaccine being developed at the University of Oxford, UK, that is also in human trials protected six monkeys from pneumonia, but the animals noses harboured as much virus as did those of unvaccinated monkeys, researchers reported last week in a bioRxiv preprint. A Chinese group reported similar caveats about its own vaccines early animal tests this month.

Despite uncertainties, all three teams are pressing ahead with clinical trials. These early studies are meant mainly to test safety, but larger clinical trials designed to determinewhether the vaccines can actually protect humansfrom COVID-19 could report in the next few months.

Still, the early data offer clues as to how coronavirus vaccines might generate a strong immune response. Scientists say that animal data will be crucial for understanding how coronavirus vaccines work, so that the most promising candidates can be identified quickly and then refined. We might have vaccines in the clinic that are useful in people within 12 or 18 months, says Dave OConnor, a virologist at the University of WisconsinMadison. But were going to need to improve on them to develop second- and third-generation vaccines.

Modernas vaccine, which is being co-developed with the US National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, began safety testing in humans in March. The vaccine consists of mRNA instructions for building the coronaviruss spike protein; it causes human cells to churn out the foreign protein, alerting the immune system. Althoughsuch RNA-based vaccinesare easy to develop, none has yet been licensed anywhere in the world.

In its press release, the company reported that 45 study participants who received one or two doses of the vaccine developed a strong immune response to the virus. Researchers measured virus-recognizing antibodies in 25 participants, and detected levels similar to or higher than those found in the blood of people who have recovered from COVID-19.

Tal Zaks, Modernas chief medical officer, said in a presentation to investors that these antibody levels bode well for the vaccine preventing infection. If you get to the level of people who had disease, that should be enough, Zaks said.

But its not at all clear whether the responses are enough to protect people from infection, because Moderna hasnt shared its data, says Peter Hotez, a vaccine scientist at Baylor College of Medicine in Houston, Texas. Im not convinced that this is really a positive result, Hotez says. He points to a May 15bioRxiv preprint3that found that most people who have recovered from COVID-19 without hospitalization do not produce high levels of neutralizing antibodies, which block the virus from infecting cells. Moderna measured these potent antibodies in eight trial participants and found their levels to be similar to those in recovered patients.

Hotez also has doubts about the Oxford teams first results, which found that monkeys produced modest levels of neutralizing antibodies after receiving one dose of the vaccine (the same regime that is being tested in human trials). It looks like those numbers need to be considerably higher to afford protection, says Hotez. The vaccine is a made from a chimpanzee virus that has been genetically altered to produce a coronavirus protein.

Hotez says that the vaccine being developed by Sinovac Biotech in Beijing seems to have elicited a more promising antibody response in macaque monkeys that received three doses, as reportedin a May 5 paper inScience. That vaccine is comprised of chemically inactivated SARS-CoV-2 particles.

No one yet knows the precise nature of the immune response that protects people from COVID-19, and the levels of neutralizing antibodies made by the monkeys in the Oxford Study might be enough to protect people from infection, says Michael Diamond, a viral immunologist at Washington University in St. Louis, Missouri, who is a member of Modernas scientific advisory board. If not, a second injection would probably boost levels appreciably. What we dont know is how long theyll last, he adds.

Still more questions hover over experiments showing that vaccines can protect animals from infection. Moderna said its vaccine stopped the virus replicating in the lungs of mice. The rodents had been infected with a version of the virus that was genetically modified to let it attack mouse cells, which are not ordinarily susceptible to SARS-CoV-2, according to Zakss presentation. But the mutation affects the protein that most vaccines, including Modernas, use to stimulate the immune system, and this could change the animals response to infection.

The Oxford monkeys were given an extremely high dose of virus after receiving the vaccine, says Sarah Gilbert, an Oxford vaccinologist who co-led the study with Vincent Munster, a virologist at NIAIDs laboratories in Hamilton, Montana. This could explain why the vaccinated animals had just as much SARS-CoV-2 genetic materials in their noses as control animals, even though the vaccinated monkeys didn't develop any signs of pneumonia. Administering high doses ensures that the animals are infected with the virus, but it might not replicate natural infections. The Oxford study did not measure whether the virus was still infectious, Diamond says, and the genetic material could represent virus particles inactivated by the monkeys immune response, or the viruses the researchers administered, rather than an ongoing infection.

Still, the result is a concern that raises the possibility that vaccinated people could still spread the virus, says Douglas Reed, an aerobiologist at the University of Pittsburgh Center for Vaccine Research in Pennsylvania. Ideally, you want a vaccine that would protect against disease and against transmission, so that we can kind of break the chain, he says.

One way to find out whether vaccines can prevent transmission would be to study them in animals that are naturally susceptible to the virus and seem capable of spreading it, such as ferrets and hamsters, says Reed. He and other researchers also point out that macaques display only mild symptoms of coronavirus infection, and they wonder whether vaccines should be trialled in animals that develop more severe disease.

Although assessing vaccines potential efficacy is difficult, the latest data are clearer on safety, say researchers. The Moderna vaccine caused few severe and no lasting health problems in trial participants. The vaccinated Oxford and Sinovac monkeys did not develop an exacerbated disease after infection a key fear, because an inactivated vaccine for the related coronavirus that causes SARS (severe acute respiratory syndrome) showed signs of this in macaques.

Stanley Perlman, a coronavirologist at the University of Iowa in Iowa City, says that the animal studies conducted so far can tell vaccine developers only so much. People are doing as best they can, he says. None of the data that hes seen should dissuade developers from pressing on with trials in humans to determine whether the vaccines work, he says.

Moderna will soon begin a phase II trial involving 600 participants. It hopes to begin a phase III efficacy trial in July, to test whether the vaccine can prevent disease in high-risk groups, such as health-care workers and people with underlying medical problems. Zaks said that further animal studies, including some in monkeys, were under way, and that it wasnt yet clear which animal would best predict whether and how the vaccine works.

The Oxford team has already enrolled more than 1,000 people in its UK trial. Some volunteers have received a placebo, so the trial could allow researchers to determine whether the vaccine works in humans over the coming months. The lack of safety problems in the teams monkey study was reassuring, Gilbert says.

We dont really need any more data from animal trials to continue, she says. If we get human efficacy, weve got human efficacy, and thats what matters.

This article is reproduced with permission and wasfirst publishedon May 19 2020.

Read more about the coronavirus outbreak from Scientific American here. And read coverage from our international network of magazines here.

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Coronavirus Vaccine Trials Have Delivered Their First Results--But Their Promise Is Still Unclear - Scientific American

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