StemCell Therapy

The novel coronavirus behind the COVID-19 pandemic may have jumped from its original animal host into humans as early as October, according to the latest analysis of the changing viral genome.

Scientists analysing the genetic trees of 7,666 SARS-CoV-2 genomes collected from around the world estimated a common ancestor to the circulating COVID virus strains as having most likely appeared in China at some point between Oct. 6 and Dec. 11, 2019.

The genomic diversity of the global SARS-CoV-2 population being recapitulated in multiple countries points to extensive worldwide transmission of COVID-19, likely from extremely early on in the pandemic, they write in a paper just published in the peer-reviewed journal Infection, Genetics and Evolution.

This suggests that the virus was probably infecting people in multiple countries weeks or even months before the official outbreak began in January 2020 in Wuhan, China.

All these ideas about trying to find a Patient Zero are pointless because there are so many patient zeros, genetics researcher Francois Balloux of the University College London Genetics Institute told CNN. It has been introduced and introduced and introduced in almost all countries.

However, despite this evidence of the virus already circulating globally much earlier than previously suspected, the scientists squashed the hopeful notion that sufficient numbers of people might already have been exposed to the virus to build up substantial herd immunity around the world.

This rules out any scenario that assumes SARS-CoV-2 may have been in circulation long before it was identified, and hence have already infected large proportions of the population, the scientists wrote in their paper, entitled Emergence of genomic diversity and recurrent mutations in SARS-CoV-2.

The latest analysis provides no evidence to support recent conspiracy theories asserting that the COVID-19 virus was deliberately created or released, intentionally or otherwise, from a lab. The authors reference earlier genetic analysis making clear that SARS-CoV-2 has natural origins, most likely having jumped into humans originally from bats.

SARS-CoV-2 shares 96 percent of its genome with a horseshoe bat virus called BatCoV RaTG13, which researchers say shows no evidence of recombination events. An intermediate animal host connecting this bat virus to human COVID has still not been definitively identified, but is thought to have been pangolins an endangered animal illegally traded in Asian wildlife markets and also widely used in non-scientific Chinese medicine.

Dr. Anthony Fauci,director of the United States National Institute of Allergies and Infectious Diseases, has also spoken out strongly against ideas of deliberate or even accidental release from a Chinese lab. Everything about the stepwise evolution over time strongly indicates that [this virus] evolved in nature and then jumped species, Fauci told National Geographic.

There is some good news from this latest genomic analysis because it shows only a limited rate of mutations among the multiple strains of SARS-CoV-2, which still have enough of their genes and proteins in common to mean that any vaccine or treatment drug should have long-term efficacy.

The study also helps identify the parts of the SARS-CoV-2 genome which are conserved meaning they stay the same despite other genetic variations helping vaccine researchers better identify targets for their differing approaches. The researchers write that it is important to stress that there is no evidence for the evolution of distinct phenotypes in SARS-CoV-2 at this stage.

According to the World Health Organization, there are now more than 100 COVID-19 candidate vaccines in development around the world.

Go here to see the original:
Covid pandemic might have begun as early as October, experts say - Alliance for Science

SAN FRANCISCO, May 5, 2020 /PRNewswire/ -- Invitae Corporation (NYSE: NVTA), a leading medical genetics company, today announced financial and operating results for the first quarter ended March 31, 2020.

"We started the year with a very strong quarter, delivering record growth in volume and first quarter revenues and giving us strong momentum as we began experiencing impacts from the pandemic. As healthcare has shifted, we have been able to quickly leverage our pre-existing strengths, notably our telehealth offerings and our ability to deliver genetic testing remotely," said Sean George, co-founder and chief executive officer of Invitae. "Looking ahead, our investments in diversified products, services, technologies and geographies mean we are well-equipped to drive growth across an increasing number of customer segments as we drive genetics into mainstream medicine."

First Quarter 2020 Financial Results

Total operating expense, excluding cost of revenue, for the first quarter of 2020 was $121.6 million. Non-GAAP operating expense, which excludes amortization of acquired intangible assets and acquisition-related stock-based compensation, was $101.9 million in the first quarter of 2020. Interest and other expense, net and net loss are preliminary and subject to change as we finalize acquisition-related adjustments. These adjustments will be incorporated in Invitae's Form 10-Q to be filed with the SEC on or before May 11, 2020.

Preliminary net loss for the first quarter of 2020 was $102.2 million, or $1.03 preliminary net loss per share, compared to a net loss of $37.7 million in the first quarter of 2019, or $0.47 net loss per share. Preliminary non-GAAP net loss was $79.8 million in the first quarter of 2020, or $0.80 preliminary non-GAAP net loss per share.

At March 31, 2020 cash, cash equivalents, restricted cash, and marketable securities totaled $301.0 million. Net decrease in cash, cash equivalents and restricted cash for the quarter was $61.0 million. Cash burn, including various acquisition-related expenses, was $98.5 million for the quarter; $66.2 million when excluding $32.3 million cash paid to acquire Diploid.

In April, the company completed a public offering of common stock, resulting in gross proceeds of $184.0 million and $173.0 million in net proceeds after deducting underwriting discounts and commissions and offering expenses.

COVID-19 ImpactGlobal stay-at-home orders, lockdowns and shutdown of non-emergency healthcare and elective procedures began impacting Invitae during the second half of March. Invitae took a number of steps in response, including:

The impact of the pandemic on testing volume has and is likely to continue to vary based on clinical area, geography and clinician type. In response, the company has taken a number of steps to reduce cash burn.

The company is continuing to closely monitor the impact of the COVID-19 pandemic and plans to continue to reduce previously communicated cash burn through the remainder of 2020.

Given the unknown duration and extent of COVID-19's impact on our business, and the healthcare system in general, Invitae has previously withdrawn its 2020 guidance.

Corporate and Scientific Highlights

Webcast and Conference Call DetailsManagement will host a conference call and webcast today at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss financial results and recent developments. The dial-in numbers for the conference call are (866) 324-3683 for domestic callers and (509) 844-0959 for international callers, and the reservation number for both is 9557177. Please note, after dialing in, you will be prompted to enter the Conference ID and then the pound "#" sign to enter the call. Following prepared remarks, management will respond to questions from investors and analysts, subject to time limitations.

The live webcast of the call and slide deck may be accessed by visiting the investors section of the company's website atir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company's website.

About InvitaeInvitae Corporation(NYSE: NVTA)is a leading medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website at invitae.com.

Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to preliminary financial results, including preliminary net loss and net loss per share; the company's belief that it has been able to quickly leverage its telehealth offerings and its ability to deliver genetic testing remotely; he company's belief that it is well-equipped to drive growth across an increasing number of customer segments as it drives genetics into mainstream medicine; the impact of the COVID-19 pandemic on the company's business, and the measures it has taken or may take In the future with respect thereto; the impact of the company's acquisitions, partnerships and product offerings; and the company's beliefs regarding the growth of its business, its position and impact on the genetic testing industry, its success in executing on its mission and achieving its goals, and the benefits of genetic testing. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic on the company, and the effectiveness of the efforts it has taken or may take in the future in response thereto; the completion of the closing process, including finalization of acquisition-related adjustments and the magnitude thereof; the company's ability to continue to grow its business, including internationally; the company's history of losses; the company's ability to compete; the company's failure to manage growth effectively; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the company's failure to successfully integrate or fully realize the anticipated benefits of acquired businesses; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; and the other risks set forth in the company's Annual Report on Form 10-K for the year ended December 31, 2019. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

Non-GAAP Financial MeasuresTo supplement Invitae's consolidated financial statements prepared in accordance with generally accepted accounting principles in the United States (GAAP), the company is providing several non-GAAP measures, including non-GAAP gross profit, non-GAAP cost of revenue, non-GAAP operating expense, including non-GAAP research and development, non-GAAP selling and marketing and non-GAAP general and administrative, as well as non-GAAP net loss and net loss per share and non-GAAP cash burn. These non-GAAP financial measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similarly-titled measures presented by other companies. Management believes these non-GAAP financial measures are useful to investors in evaluating the company's ongoing operating results and trends.

Management is excluding from some or all of its non-GAAP operating results (1) amortization of acquired intangible assets and (2) acquisition-related stock-based compensation related to inducement grants. These non-GAAP financial measures are limited in value because they exclude certain items that may have a material impact on the reported financial results. Management accounts for this limitation by analyzing results on a GAAP basis as well as a non-GAAP basis and also by providing GAAP measures in the company's public disclosures.

Cash burn excludes (1) changes in marketable securities and (2) cash received from exercises of warrants. Management believes cash burn is a liquidity measure that provides useful information to management and investors about the amount of cash consumed by the operations of the business. A limitation of using this non-GAAP measure is that cash burn does not represent the total change in cash, cash equivalents, and restricted cash for the period because it excludes cash provided by or used for other operating, investing or financing activities. Management accounts for this limitation by providing information about the company's operating, investing and financing activities in the statements of cash flows in the consolidated financial statements in the company's most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and by presenting net cash provided by (used in) operating, investing and financing activities as well as the net increase or decrease in cash, cash equivalents and restricted cash in its reconciliation of cash burn.

In addition, other companies, including companies in the same industry, may not use the same non-GAAP measures or may calculate these metrics in a different manner than management or may use other financial measures to evaluate their performance, all of which could reduce the usefulness of these non-GAAP measures as comparative measures. Because of these limitations, the company's non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. Investors are encouraged to review the non-GAAP reconciliations provided in the tables below.

INVITAE CORPORATION

Consolidated Balance Sheets

(in thousands)

(unaudited)

March 31,2020

December 31,2019

Assets

Current assets:

Cash and cash equivalents

$

90,220

$

151,389

Marketable securities

204,388

240,436

Accounts receivable

37,734

32,541

Prepaid expenses and other current assets

25,085

18,032

Total current assets

357,427

442,398

Property and equipment, net

41,085

37,747

Operating lease assets

37,588

36,640

Restricted cash

6,343

6,183

Intangible assets, net

163,378

125,175

Goodwill

177,432

126,777

Other assets

7,635

6,681

Total assets

$

790,888

$

781,601

Liabilities and stockholders' equity

Total liabilities and stockholders' equity

$

790,888

$

781,601

Certain line items have been condensed as we finalize acquisition-related adjustments. These adjustments will be incorporated in Invitae's Form 10-Q to be filed with the SEC on or before May 11, 2020.

INVITAE CORPORATION

Consolidated Statements of Operations

(in thousands, except per share data)

(unaudited)

Three Months EndedMarch 31,

2020

2019

Revenue:

Test revenue

$

63,078

$

39,619

Other revenue

1,170

934

Total revenue

64,248

40,553

Cost of revenue

40,422

21,254

Research and development

55,668

17,994

View post:
Invitae Reports More Than $64 Million in Revenue Driven by More Than 154,000 Samples Accessioned in the First Quarter of 2020 - PRNewswire

The novel coronavirus causing COVID-19 seems to hit some people harder than others, with some people experiencing only mild symptoms and others being hospitalized and requiring ventilation. Though scientists at first thought age was the dominant factor, with young people avoiding the worst outcomes, new research has revealed a suite of features impacting disease severity. These influences could explain why some perfectly healthy 20-year-old with the disease is in dire straits, while an older 70-year-old dodges the need for critical interventions.

These risk factors include:AgeDiabetes (type 1 and type 2)Heart disease and hypertensionSmokingBlood typeObesityGenetic factors

About 8 out of 10 deaths associated with COVID-19 in the U.S. have occurred in adults ages 65 and older, according to the U.S. Centers for Disease Control and Prevention (CDC). The risk of dying from the infection, and the likelihood of requiring hospitalization or intensive medical care, increases significantly with age. For instance, adults ages 65-84 make up an estimated 4-11% of COVID-19 deaths in the U.S, while adults ages 85 and above make up 10-27%.

The trend may be due, in part, to the fact that many elderly people have chronic medical conditions, such as heart disease and diabetes, that can exacerbate the symptoms of COVID-19, according to the CDC. The ability of the immune system to fight off pathogens also declines with age, leaving elderly people vulnerable to severe viral infections, Stat News reported.

Related: Coronavirus in the US: Latest COVID-19 news and case counts

Diabetes mellitus a group of diseases that result in harmful high blood sugar levels also seems to be linked to risk of more severe COVID-19 infections.

The most common form in the U.S. is type 2 diabetes, which occurs when the body's cells don't respond to the hormone insulin. As a result, the sugar that would otherwise move from the bloodstream into cells to be used as energy just builds up in the bloodstream. (When the pancreas makes little to no insulin in the first place, the condition is called type 1 diabetes.)

In a review of 13 relevant studies, scientists found that people with diabetes were nearly 3.7 times more likely to have a critical case of COVID-19 or to die from the disease compared with COVID-19 patients without any underlying health conditions (including diabetes, hypertension, heart disease or respiratory disease), they reported online April 23 in the Journal of Infection.

Even so, scientists don't know whether diabetes is directly increasing severity or whether other health conditions that seem to tag along with diabetes, including cardiovascular and kidney conditions, are to blame.

That fits with what researchers have seen with other infections and diabetes. For instance, flu and pneumonia are more common and more serious in older individuals with type 2 diabetes, scientists reported online April 9 in the journal Diabetes Research and Clinical Practice. In a literature search of relevant studies looking at the link between COVID-19 and diabetes, the authors of that paper found a few possible mechanisms to explain why a person with diabetes might fare worse when infected with COVID-19. These mechanisms include: "Chronic inflammation, increased coagulation activity, immune response impairment and potential direct pancreatic damage by SARS-CoV-2."

Related: 13 coronavirus myths busted by science

Mounting research has shown the progression of type 2 diabetes is tied to changes in the body's immune system. This link could also play a role in poorer outcomes in a person with diabetes exposed to SARS-CoV-2, the virus that causes COVID-19.

No research has looked at this particular virus and immune response in patients with diabetes; however, in a study published in 2018 in the Journal of Diabetes Research, scientists found through a review of past research that patients with obesity or diabetes showed immune systems that were out of whack, with an impairment of white blood cells called Natural Killer (NK) cells and B cells, both of which help the body fight off infections. The research also showed that these patients had an increase in the production of inflammatory molecules called cytokines. When the immune system secretes too many cytokines,a so-called "cytokine storm" can erupt and damage the body's organs. Some research has suggested that cytokine storms may be responsible for causing serious complications in people with COVID-19, Live Science previously reported. Overall, type 2 diabetes has been linked with impairment of the very system in the body that helps to fight off infections like COVID-19 and could explain why a person with diabetes is at high risk for a severe infection.

Not all people with type 2 diabetes are at the same risk, though: A study published May 1 in the journal Cell Metabolism found that people with diabetes who keep their blood sugar levels in a tighter range were much less likely to have a severe disease course than those with more fluctuations in their blood sugar levels.

Scientists aren't sure whether this elevated risk of a severe COVID-19 infection also applies to people with type 1 diabetes (T1D). A study coordinated by T1D Exchange a nonprofit research organization focused on therapies for those with type 1 diabetes launched in April to study the outcomes of T1D patients infected with COVID-19. When a person with T1D gets an infection, their blood sugar levels tend to spike to dangerous levels and they can have a buildup of acid in the blood, something called diabetic ketoacidosis. As such, any infection can be dangerous for someone with type 1 diabetes.

People with conditions that affect the cardiovascular system, such as heart disease and hypertension, generally suffer worse complications from COVID-19 than those with no preexisting conditions, according to the American Heart Association. That said, historically healthy people can also suffer heart damage from the viral infection.

The first reported coronavirus death in the U.S., for instance, occurred when the virus somehow damaged a woman's heart muscle, eventually causing it to burst, Live Science reported. The 57-year-old maintained good health and exercised regularly before becoming infected, and she reportedly had a healthy heart of "normal size and weight." A study of COVID-19 patients in Wuhan, China, found that more than 1 in 5 patients developed heart damage some of the sampled patients had existing heart conditions, and some did not.

In seeing these patterns emerge, scientists developed several theories as to why COVID-19 might hurt both damaged hearts and healthy ones, according to a Live Science report.

In one scenario, by attacking the lungs directly, the virus might deplete the body's supply of oxygen to the point that the heart must work harder to pump oxygenated blood through the body. The virus might also attack the heart directly, as cardiac tissue contains angiotensin-converting enzyme 2 (ACE2) a molecule that the virus plugs into to infect cells. In some individuals, COVID-19 can also kickstart an overblown immune response known as a cytokine storm, wherein the body becomes severely inflamed and the heart could suffer damage as a result.

People who smoke cigarettes may be prone to severe COVID-19 infections, meaning they face a heightened risk of developing pneumonia, suffering organ damage and requiring breathing support. A study of more than 1,000 patients in China, published in the New England Journal of Medicine, illustrates this trend: 12.3% of current smokers included in the study were admitted to an ICU, were placed on a ventilator or died, as compared with 4.7% of nonsmokers.

Cigarette smoke might render the body vulnerable to the coronavirus in several ways, according to a recent Live Science report. At baseline, smokers may be vulnerable to catching viral infections because smoke exposure dampens the immune system over time, damages tissues of the respiratory tract and triggers chronic inflammation. Smoking is also associated with a multitude of medical conditions, such as emphysema and atherosclerosis, which could exacerbate the symptoms of COVID-19.

A recent study, posted March 31 to the preprint database bioRxiv, proposed a more speculative explanation as to why COVID-19 hits smokers harder. The preliminary research has not yet been peer-reviewed, but early interpretations of the data suggest that smoke exposure increases the number of ACE2 receptors in the lungs the receptor that SARS-CoV-2 plugs into to infect cells.

Many of the receptors appear on so-called goblet and club cells, which secrete a mucus-like fluid to protect respiratory tissues from pathogens, debris and toxins. It's well-established that these cells grow in number the longer a person smokes, but scientists don't know whether the subsequent boost in ACE2 receptors directly translates to worse COVID-19 symptoms. What's more, it's unknown whether high ACE2 levels are relatively unique to smokers, or common among people with chronic lung conditions.

Several early studies have suggested a link between obesity and more severe COVID-19 disease in people. One study, which analyzed a group of COVID-19 patients who were younger than the age of 60 in New York City, found that those who were obese were twice as likely as non-obese individuals to be hospitalized and were 1.8 times as likely to be admitted into critical care.

"This has important and practical implications" in a country like the U.S. where nearly 40% of adults are obese, the authors wrote in the study, which was accepted into the journal Clinical Infectious Diseases but not yet peer-reviewed or published. Similarly, another preliminary study that hasn't yet been peer-reviewed found that the two biggest risk factors for being hospitalized from the coronavirus are age and obesity. This study, published in medRxiv looked at data from thousands of COVID-19 patients in New York City, but studies from other cities around the world found similar results, as reported by The New York Times.

A preliminary study from Shenzhen, China, which also hasn't been peer-reviewed, found that obese COVID-19 patients were more than twice as likely to develop severe pneumonia as compared with patients who were normal weight, according to the report published as a preprint online in the journal The Lancet Infectious Diseases. Those who were overweight, but not obese, had an 86% higher risk of developing severe pneumonia than did people of "normal" weight, the authors reported. Another study, accepted into the journal Obesity and peer-reviewed, found that nearly half of 124 COVID-19 patients admitted to an intensive care unit in Lille, France, were obese.

It's not clear why obesity is linked to more hospitalizations and more severe COVID-19 disease, but there are several possibilities, the authors wrote in the study. Obesity is generally thought of as a risk factor for severe infection. For example, those who are obese had longer and more severe disease during the swine flu epidemic, the authors wrote. Obese patients might also have reduced lung capacity or increased inflammation in the body. A greater number of inflammatory molecules circulating in the body might cause harmful immune responses and lead to severe disease.

Blood type seems to be a predictor of how susceptible a person is to contracting SARS-CoV-2, though scientists haven't found a link between blood type per se and severity of disease.

Jiao Zhao, of The Southern University of Science and Technology, Shenzhen, and colleagues looked at blood types of 2,173 patients with COVID-19 in three hospitals in Wuhan, China, as well as blood types of more than 23,000 non-COVID-19 individuals in Wuhan and Shenzhen. They found that individuals with blood types in the A group (A-positive, A-negative and AB-positive, AB-negative) were at a higher risk of contracting the disease compared with non-A-group types. People with O blood types (O-negative and O-positive) had a lower risk of getting the infection compared with non-O blood types, the scientists wrote in the preprint database medRxiv on March 27; the study has yet to be reviewed by peers in the field.

In a more recent study of blood type and COVID-19, published online April 11 to medRxiv, scientists looked at 1,559 people tested for SARS-CoV-2 at New York Presbyterian hospital; of those, 682 tested positive. Individuals with A blood types (A-positive and A-negative) were 33% more likely to test positive than other blood types and both O-negative and O-positive blood types were less likely to test positive than other blood groups. (There's a 95% chance that the increase in risk ranges from 7% to 67% more likely.) Though only 68 individuals with an AB blood type were included, the results showed this group was also less likely than others to test positive for COVID-19.

The researchers considered associations between blood type and risk factors for COVID-19, including age, sex, whether a person was overweight, other underlying health conditions such as diabetes mellitus, hypertension, pulmonary diseases and cardiovascular diseases. Some of these factors are linked to blood type, they found, with a link between diabetes and B and A-negative blood types, between overweight status and O-positive blood groups, for instance, among others. When they accounted for these links, the researchers still found an association between blood type and COVID-19 susceptibility. When the researchers pooled their data with the research by Zhao and colleagues out of China, they found similar results as well as a significant drop in positive COVID-19 cases among blood type B individuals.

Why blood type might increase or decrease a person's risk of getting SARS-CoV-2 is not known. A person's blood type indicates what kind of certain antigens cover the surfaces of their blood cells; These antigens produce certain antibodies to help fight off a pathogen. Past research has suggested that at least in the SARS coronavirus (SARS-CoV), anti-A antibodies helped to inhibit the virus; that could be the same mechanism with SARS-CoV-2, helping blood group O individuals to keep out the virus, according to Zhao's team.

Many medical conditions can worsen the symptoms of COVID-19, but why do historically healthy people sometimes fall dangerously ill or die from the virus? Scientists suspect that certain genetic factors may leave some people especially susceptible to the disease, and many research groups aim to pinpoint exactly where those vulnerabilities lie in our genetic code.

In one scenario, the genes that instruct cells to build ACE2 receptors may differ between people who contract severe infections and those who hardly develop any symptoms at all, Science magazine reported. Alternatively, differences may lie in genes that help rally the immune system against invasive pathogens, according to a recent Live Science report.

For instance, a study published April 17 in the Journal of Virology suggests that specific combinations of human leukocyte antigen (HLA) genes, which train immune cells to recognize germs, may be protective against SARS-CoV-2, while other combinations leave the body open to attack. HLAs represent just one cog in our immune system machinery, though, so their relative influence over COVID-19 infection remains unclear. Additionally, the Journal of Virology study only used computer models to simulate HLA activity against the coronavirus; clinical and genetic data from COVID-19 patients would be needed to flesh out the role of HLAs in real-life immune responses.

Originally published on Live Science.

Go here to read the rest:
Why COVID-19 kills some people and spares others. Here's what scientists are finding. - Livescience.com

Six weeks ago, with little fanfare, a network of geneticists launched an obscure but potentially game-changing initiative. Their aim: to learn why people with particular DNA profiles end up dying from the coronavirusor completely avoiding its effects. Ultimately, they want to devise ways for scientists to cook up new therapies that might alter how our nanosize genes operate as a way of reversing or accelerating the pathogens progress. Called the COVID-19 Host Genetics Initiative, the project now involves close to 700 scientists and researchers, worldwide, who are busily comparing DNA data from pandemic victims to literally millions of existing DNA profiles of millions of people.

To appreciate how our genes might be impacted by the onslaught of COVID-19, imagine this: that a tiny, invisible bug is hovering over the surface of a cell inside your bodysay a lung cell. You dont know it yet, but youve just been infected with SARS-Cov-2. Maybe it came from that jogger who whizzed past you on the sidewalk, or that tabletop you touched before rubbing your eyes. Whatever its source, there it is, circulating inside you: a fuzzy, sphere-shaped pathogen thats less than 1/1000 the width of a human hair. Prickly, with spikes on its outside, its searching for a place to plug into and enter your cell. Its a little like a key and a lock, where the key (the virus) wants to slip into the keyhole (a receptor on the cell) and then release a payload that will be up to no good.

Except that, in some people, the virus-key doesnt fit the lock and is blocked from entering the cell. In others, it slips right in, leading to illness and sometimes to rapid deterioration and even death. One potential differencesay geneticists who are working day and night to better understand how SARS-Cov-2 invades and attacks our cellsmight be because your DNA code differs from mine. Yours might inherently spurn the virus at the cellular level; mine might make me more susceptible.

So what determines who gets dangerously sick? We know that people who are older and have underlying diseases like diabetes and heart disease are at higher risk for having a bad response to COVID-19, explained Mark Daly, a 52-year-old geneticist and the director of the Institute for Molecular Medicine in Helsinki, Finland. Other factors include higher risk biases that involve ethnicity, class, vocation, geographic location, and the medical resources available at the time of treatment. And yet, according to Daly, this doesnt explain why relatively healthy people, including young people, are sometimes having severe and life-threatening reactions such as very high fevers, pneumonia, and difficulty with breathing that requires oxygen and sometimes a ventilator. Most likely this has something to do with differences in their genes.

Daly should know. With his Paul Reverelike ponytail, circular hippie glasses, and lean, determined face, hes a pioneer of modern genetics who was a key player during and after the Human Genome Project, the huge international effort in the 1990s and early 2000s that sequenced the first-ever human genome. And as the pandemic has been raging, Daly, a physicist, decided to help spearhead a remarkable hive-mind effort: the COVID-19 Host Genetics Initiative.

The project was announced on March 16 in a tweet posted by Dalys cohort Andrea Ganna: Goal: aggregate genetic and clinical information on individuals affected by COVID-19. The response was immediate. Within days, scientists from over 150 organizations in more than 30 countries on six continents agreed to join. Thats the ideal use of the hive mind: a conglomeration of big brains and, in this case, their disparate data sources, to solve one huge problem. Participants have come not only from Harvard and MIT (institutions with which Daly has ongoing affiliations) and the usual institutional suspects in North America, Europe, and the wealthier Asian countries, but also from the Qatar Genome Program, Vietnams SARS-Cov-2 Susceptibility Program, and CLHORAZbased in Burkina Faso.

View original post here:
What Do Your Genetics Have to Do With Your Chances of Dying From Coronavirus? - Vanity Fair

Well come clean the pints and pub grub lifestyle often associated with the great British local hasnt dovetailed all that smoothly with the NHS since its launch on 5 July 1948, even if the community spirit that underpins arguably this countrys greatest piece of modern policy-making is broadly shared by pubs.

Born from a long-standing ideal that healthcare should be readily available based on clinical need rather than ability to pay, health minister Aneurin Bevan unveiled the nascent NHS at Park Hospital in Manchester after the passage of the National Health Service Act in 1946.

Despite extensive cutbacks in recent years, today, total health spending in England stands at around 130bn more than the annual GDP of Ukraine or Morocco with the NHS employing more people across the UK than live in Birmingham. According to a report by the Department of Health in December 2005, the NHS deals with more than 1m patients every 36 hours.

The Ram Inn, in Brundall, Norfolk, has raised close to 1,000 by asking locals to leave their rainbow images for the pub to display in return for a donation to theNorfolk & Norwich Hospitals Charity.

The operators of the Garden House in Norwich have pledged to use 2,000 worth of tech vouchers received as winners of BT Sports latest Manager of the Month prize to treat staff at local NHS services.

East Anglian pub operator Chestnut has teamed up with Food4Heroes to provide tens of thousands of free meals to the regions front-line NHS staff during the Covid-19 emergency.

Camden Town Brewery has produced a Heroes version of its flagship Hells lager which will be sold online and handed out to 20,000 NHS hospital workers - with proceeds from sales going to NHS charities.

Rendezvous & Royal Oak in Weymouth, Dorset, has raised 13,200 for Dorset County Hospital after live streaming 20-act music festival Quayfest.

Cornish brewer and pub operator St Austell Brewery has joined forces with takeaway and delivery service Pub Grub to deliver 800 bottles of soft drink to frontline staff at Royal Cornwall Hospital.

Publican Sylvia Ferron of the Foaming Tankard in Birmingham has returned to full-time work on the NHS front line during the Covid-19 emergency just months after entering the on-trade.

SallyAbof Michelin star-holding Estrella Damm Top 50 Gastropub frontrunner Harwood arms in London has cooked 100 meals per day for NHS staff through charity Hospitality for Heroes

Furloughed Stonegate Pub Company general manager, Cee-Jay Williams of the Junction Tap in Woking, Surrey, is using a 3D printer to help the NHS tackle a shortfall of 80,000 plastic visor clips.

Publican Eduardo Dantas of Tia Maria Bar & Restaurant in Vauxhall, south London, was reduced to tears by Staff at Londons Kings College Hospital after they surprised him with a round of applause during one of his daily deliveries of 60 free meals.

Lisa Staples of the Crown Inn, Gayton, Norfolk, has set up a website Free NHS Rooms for publicans to list their rooms so that NHS workers can find living quarters near hospitals.

The onset of the Covid-19 pandemic which has seen NHS staff treat close to 200,000 confirmed cases across the UK thus far has led to an unprecedented wave of gratitude from the public, with pubs more than playing their part.

Though the on-trade has regularly shown its support for the NHS over the years notable mentions include 2020 Great British Pub Awards-winning Best Local, the Chandos Arms in north London, throwing a street party for the NHSs 70th anniversary in 2018 and Beavertown Brewery offering free beer to blood donors the current outpouring is arguably the greatest show of support pubs have shown this countrys health service.

From Rendezvous & Royal Oak in Weymouth, Dorset, raising 13,200 for Dorset County Hospital by live streaming a 20-act music festival, for example, to pubs delivering tens of thousands of free meals and even joining efforts to make personal protective equipment, the on-trade has branched into some surprising areas to help the NHS through the ongoing emergency.

Whats more, while turning blue is medically speaking a very bad sign, a number of Britains pubs have chosen to do so in tribute to front-line workers battling Covid-19 though it wont obviously fall on the NHS to resuscitate them when operators are cleared to reopen.

The honour of having your face painted onto the front of a pub is usually one reserved for lords, ladies or royalty, but such is Britains rich medical history that a number of its nurses and scientists have had their names or tributes emblazoned above the door of a one of the nations many watering holes.

While London pubs the Sir Alexander Fleming in Paddington named after the Scottish inventor credited with the discovery of penicillin and the Florence Nightingale in Waterloo have sadly shut up shop since the turn of the Millennium, the NHSs chief architect, Bevan, has been immortalised by beverage behemoth JD Wetherspoon, which named Cardiff pub the Aneurin Bevan in his honour.

Other on-trade tributes to medicine include the Old Doctor Butlers Head in Masons Avenue, London, which was named after physician William Butler, a doctor at the court of James I who is credited with inventing the popular 17th century medicinal drink Dr Butlers purging ale.

Whats more, the namesake of Grade II-listed pub the William Harvey in Ashford, Kent, discovered the circulation of blood and once lived in what is now the pub. Though the local hospital is also named after Harvey, the pub is said to have got there first.

In a less direct tribute, the Air Balloon pub in Gloucestershire is named in tribute to physician Edward Jenner who popularised vaccination with his work to tackle smallpox. Jenner, who spent a fair amount of his time away from his work enthusing over hydrogen balloons, took to the skies from Berkeley Castle in Gloucestershire in September 1784 before landing more than 20 miles away in Birdlip where the local pub is now named in tribute to his flight.

Its not an understatement to suggest that James Watson and Francis Crick discovering the structure of DNA and how it carries genetic information in 1953 laid the groundwork for almost 75 years of game-changing medical discoveries and treatment.

Yet while images of DNAs double helix structure are among the most recognisable and iconic in science, what isnt as commonplace is the fact the pairs discovery was first announced in Cambridge pub, the Eagle.

The Grade II-listed venue was the local watering hole for scientists working at the University of Cambridges Cavendish Laboratory such as Watson and Crick, who would claim the Nobel Prize in Physiology or Medicine in 1962 for their discovery.

The pairs work to unravel DNAs structure essentially clarified how genes work. By uncovering the molecular properties of genes, Watson and Cricks discovery meant that scientists could understand how they could be damaged, why mutations could cause harmful diseases and allowed experts to work out ways to fix them. For example, in April 2020, Rhys Evans became the first child in Britain to be cured of an inherited disorder as a result of gene therapy stemming from Watson and Cricks work.

While MPs voted to ban smoking in enclosed public spaces including pubs as of summer 2007, more than 30 years prior a publican in Yorkshire created Britains first licensed smokeless zone.

According to the Pub History Society, Essex-born publican John Showers declaring the New Inn in Appletreewick near Skipton, in North Yorkshire, the worlds first no smoking inn in the early 1970s generated global media attention and even a congratulatory letter from then health minister George Godber.

While the publicans initial objection to customers smoking on his premises focused on the amount of damage it caused his pubs carpets, floors and furniture on top of nicotine staining his walls and ceilings and the fire risk the death of a close friend from lung cancer saw Showers shift his ire from building damage to disease.

Showerss then sensational ban featured on television, radio and newspapers both at home and abroad, with the publican advertising the New Inn as Englands First Fresh Air Inn.

Go here to see the original:
NHS: what role have pubs played in medical breakthroughs? - MorningAdvertiser.co.uk

CALGARY, May 6, 2020 /CNW/ - We are surrounded by data. Lots of it. It is particularly true for genomics data, and the interpretation of complex sets of information have a significant role in improving the speed and effectiveness of applying genomic data in a number of areas.

When the Enabling Bioinformatics Solutions funding competition was first announced, we identified agriculture and human health as two key areas that were generating large amounts of genomics data. Applicants were asked to submit proposals that would support the development of bioinformatic and computational approaches to help users overcome limitations in understanding, analyzing, and drawing conclusions from the genomic data being collected. An independent panel reviewed the proposals and we are pleased to announce that a total of $1.1 million has been awarded to 5 projects.

One of the successful projects is led by Tarah Lynch, Clinical Assistant Professor in the Department of Pathology & Laboratory Medicine at the University of Calgary. Her project will help store and organize the terabytes worth of data generated by new high-throughput sequencing technology.HTS is used to gather all the genetic information contained within a microorganism. This provides a high-resolution genetic fingerprint to characterize and compare isolates to each other which is important for surveillance and infection control (e.g. outbreak investigations or antimicrobial resistance trends).

The resulting database from the project can be used by researchers in public health and clinical settings and will be compatible with Alberta Precision Laboratories current databases. Tara Lynch said about her work, "This project focuses on building a strong foundation for genomics use in Alberta Precision Laboratories by creating infrastructure to organize, analyze and interpret genomic data from microorganisms such as bacteria and viruses. This project is co-led by collaborators in Calgary and Edmonton with the intention that these tools will be open source to extend their use for other genomic applications in the province."

In addition to the project led by Tara Lynch at the University of Calgary, 4 other projects were selected:

David Bailey, President and CEO of Genome Alberta sees Alberta as home to global leaders in both health and agriculture genomics and said "Investments in bioinformatics will allow researchers to better understand and derive meaning from large, complex, genomic data sets. This will not only maximize the utility of previously generated data, but also help grow Alberta's capacity for big-data analyses. This is extremely relevant for improving the quality of care for Albertans in the era of precision medicine, as well as advancing Alberta's agricultural productivity and economy."

The Enabling Bioinformatics Solutions funding was made possible through a partnership involving Genome Alberta, Genome Canada, the Government of Alberta, and Alberta Innovates.

BACKGROUNDER

1. An Open Platform for Rapid, Reproducible, Phenotype-Centric Variant Prioritization in Poorly Characterized Rare Genetic DiseaseTotal budget - $200,000Project lead: Jason de Koning, University of Calgary

In rare disease research, identifying the genetic variants that cause an individual patient's disease can be like looking for a needle in a haystack by making informed guesses about where the needle may be. This project is intended to help enable more systematic, reproducible, and objective guesses via probabilistic reasoning and systematic prioritization models. The translational software platform developed by Dr. Jason de Koning, PhD, and team will allow these models to be customized, evaluated, and shared. It will be based on a variety of state-of-the-art and highly discriminating predictors derived from open data sources. Predictions will be made in the context of what scientists think they know about a patient's disease, and on measures of confidence in those beliefs.

2. Computational tools for viral pathogenesis and epidemiology using third-generation sequencingTotal budget: $200,000Project lead: Quan Long, University of Calgary

Third-Generation Sequencing (TGS) technology offers an exciting breakthrough opportunity for virology researchers. TGS can sequence the whole genome (including methylation status) in a single read, thereby, offering unprecedented opportunities to answer clinical and scientific questions related to viral evolution, transmission and pathogenesis. Dr. Quan Long, PhD, and his team will develop novel tools for the TGS and apply them to human immunodeficiency viruses (HIV). These tools will enhance our understanding of HIV, and will be widely applicable to study other viruses.

3. From sequencer to results: enabling routine genomics use for clinical and public health microbiology in AlbertaTotal budget: $201,750Project Lead: Tarah Lynch, University of Calgary

Academic scientists in Alberta currently use high-throughput sequencing (HTS) to gather vast amounts of data, such as detailed sets of genomic information in plants and animals. For public health, the data from microbial genomes can be used to enhance virus outbreak surveillance, patient treatment plans and infection prevention programs in hospitals.Dr. Tarah Lynch, PhD, and her team are building a database to better organize and share HTS data across the province. The project also aims to improve the process used to interpret data and the way the analyzed data is displayed, ensuring it is in a format that is easier to interpret.

4. Sustaining bee population health for Alberta's agriculture system. BeeBiome Data PortalTotal budget: $384,288Project lead: Rodrigo Ortega-Polo, Agriculture and Agri-Food Canada

Bees are fundamental to Alberta's agriculture, but are suffering severe declines worldwide due to multiple factors. The bee gut microbiome is the complex community of microorganisms living within the bee digestive system, and it directly impacts bee health and immunity. Now that a large amount of data on the bee microbiome is available, there is an urgent need for those data to be more accessible so that information can be applied for scientific discoveries and can be translated for stakeholder use.The goal of this project is to advance the development of the BeeBiome Data Portal, which will allow analysis and sharing of information on the microorganisms and viruses associated with bees.The outcome of the project will be greater accessibility to bee microbiome data and its use for new scientific discoveries and for translation efforts. This increased accessibility will benefit the scientific community, stakeholders and policy makers by enabling data-driven approaches to decision making regarding bee health.

5. Better cattle breeding predictions for Alberta producersTotal budget - $160,00Project lead Graham Plastow, University of Alberta

Results from the latest run of the 1000 bull genomes project, together with phenotypes and genotypes on tens of thousands of Alberta beef cattle, provides a vast amount of information that could greatly improve the accuracy of genomic prediction for economically important traits. The main challenge is to develop statistically powerful and efficient methods for largescale analysis of this information. The goal of this project is to develop a computing algorithm for such analysis. We plan to evaluate the algorithm for accuracy and develop a cloud-based platform that automatically runs the process.This project will provide the Alberta beef industry and research institutions with a powerful tool for fast integration of sequence information into genomic research and applications. It should also improve the accuracy of genomic prediction compared to current methods.

About Genome AlbertaGenome Alberta is a publicly funded not-for profit corporation which invests primarily in large-scale genome sciences research projects and technology platforms focused on areas of strategic importance to the province (e.g. human health, forestry, plant and animal agriculture, energy, and environment). By working collaboratively with government, universities, and industry, Genome Alberta is a catalyst for a vibrant life sciences cluster with far reaching social and economic benefits for Alberta and Canada. To date, the organization has managed a research portfolio with approved budgets totaling more than $255 million. Please visit Genome Alberta's website for more information.

SOURCE Genome Alberta

For further information: Mike Spear, Director of Corporate Communications, Genome Alberta, [emailprotected], 403-813-5843

Home

Go here to read the rest:
Alberta Bioinformatics Expertise at Work in Health and Agriculture - Canada NewsWire

CAMBRIDGE, Mass. and NEW YORK, May 06, 2020 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, today announced that its President and Chief Executive Officer, David M. Epstein, Ph.D., will present an update about the Companys business at the Bank of America Global Research Health Care Conference 2020. The presentation will take place on Tuesday, May 12, 2020, at 4:20 PM ET.

About Black DiamondBlack Diamond Therapeutics is a precision oncology medicine company pioneering the discovery of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Companys proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families, and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations. Black Diamond was founded by David M. Epstein, Ph.D., and Elizabeth Buck, Ph.D., and, beginning in 2017, together with Versant Ventures, began building the MAP platform and chemistry discovery engine. For more information, please visit http://www.blackdiamondtherapeutics.com.

Contacts:

For Investors:Natalie Wildenradtinvestors@bdtherapeutics.com

For Media:Kathy Vincent(310) 403-8951media@bdtherapeutics.com

Here is the original post:
Black Diamond Therapeutics to Present at the Bank of America Global Research Health Care Conference 2020 - GlobeNewswire

FILE: Medical researchers perform serology, testing blood samples to find out whether someone already had and recovered from COVID-19, in Stanford University's Clinical Virology Lab in March 2020.

FILE: Medical researchers perform serology, testing blood samples to find out whether someone already had and recovered from COVID-19, in Stanford University's Clinical Virology Lab in March 2020.

Photo: Steve Fisch/Stanford Medicine

FILE: Medical researchers perform serology, testing blood samples to find out whether someone already had and recovered from COVID-19, in Stanford University's Clinical Virology Lab in March 2020.

FILE: Medical researchers perform serology, testing blood samples to find out whether someone already had and recovered from COVID-19, in Stanford University's Clinical Virology Lab in March 2020.

Why so many people are convinced that they had COVID-19 already

The week before Thanksgiving, Barbara O'Donnell came down with a wretched cough.

"It was just really bad, and it was constant," says O'Donnell, 62. "I would turn purple," gasping for breath. She could barely walk up the hills near her home outside of Philadelphia. Though she is a smoker, she was healthy and strong - "I don't get the flu, ever" - and had never experienced anything like this before.

It "felt like my lungs were so full that I wasn't going to make it," she says.

Two weeks of resting at home, and the illness vanished as quickly as it came. Two months later, California reported the country's first case of covid-19 that wasn't acquired via travel or direct contact with someone who had been abroad. Three weeks after that, Philadelphia closed nonessential businesses and issued a stay-at-home order. O'Donnell's job, as a privately employed aide for an elderly patient in a nursing home, was put on hold - the nursing home permitted only its own staff on the premises.

Sitting in her apartment, the thought occurred to her: "What if it was here way before they think it was?" she wondered. Was that cough covid?

The virus was here before anyone thought it was, we now know. Health officials in Santa Clara County, south of San Francisco, recently determined that at least two people who died in early and mid-February tested positive for the virus. But that doesn't answer the question that has been spreading, afflicting anyone who recently - or even kind of recently - experienced any covid symptoms:

Did I have it? I think I had it.

"I've been getting emails from hundreds, maybe thousands of people telling me, 'I'm sure I had it,' " Eran Bendavid, an associate professor of medicine specializing in infectious disease who is studying covid-19 at Stanford University.

"I am 99 percent sure I had it," says Janet Truchard, 58, who woke up in her Las Vegas home on Jan. 15 "sick as a dog" with a fever, dry cough, migraine and chest pain. She visited several doctors who prescribed various courses of antibiotics, diagnosing her with sinusitis and then allergies. The cough persisted all the way through March 25, but a chest X-ray came back clear.

Thinkihadititis is a condition afflicting people who experienced covid-like illnesses that befell them long before coronavirus was a thing. It happens when bits of news and scientific findings lodge in the parts of the brain that incubate hope - Oh hey, maybe I already beat it! - and anxiety - Oh God, maybe I gave it to a bunch of people.

Like covid-19, Thinkihadititis has infected some high-profile patients. "Sopranos" star Michael Imperioli told Page Six he was "certain" he caught the virus in early February. A star of the reality series "Love Island" thinks she "had the 'rona" while the show was filming in South Africa in January. And Patti Stanger, star of the Bravo show "Millionaire Matchmaker," was stricken with shallow breathing, a fever, fatigue and nausea after a January vacation in Miami, despite flying with a face mask at the advice of her nail technician. She had to skip the Grammys and had a panic attack when her fever spiked to 102.

"I didn't get up for three weeks," she says. "I didn't eat a thing. I lived on bone broth and crackers."

Later on, when news broke that the coronavirus had arrived in America earlier than we ever knew, "I thought, I could be one of those people," she says.

"I started hearing from all these friends saying, 'I think I had it, I think I had it.'"

- - -

No one wants to have covid-19, but everyone wants to have had it.

And recent research suggests that many people have already had it without knowing. Epidemiologists have said that the number of infections greatly exceeds the official count of cases, potentially by a factor of 10 or more, since people can be asymptomatic carriers of the illness, and because not every victim has been tested.

The World Health Organization has cautioned against the assumption that those who have already had the illness can't get it again. Researchers are still learning about the protective benefits that the disease's antibodies might bestow on survivors.

But after two long months of bad news about the painful effects and unpredictable deadliness of covid-19 - the sudden crashes, the mysterious strokes, the wide-ranging attacks on the body - who could be blamed for wondering, optimistically, about whether they've already joined the ranks of the Recovered?

JoAnna Fischer is sure she had covid-19. She lost her sense of smell, and for three months, she had a cough and chest pain so bad she needed supplemental oxygen. Her husband came down with a respiratory illness, and so did her cat.

One problem: Fischer fell ill all the way back in September, when she was living in northeast Pennsylvania. That's far earlier than epidemiologists believe the disease could have come to the United States.

"There is 0.0% probability that #SARSCoV2 was circulating with community transmission in the US in or before Nov 2019," tweeted Trevor Bedford, a computational biologist at Fred Hutchinson Cancer Research Center who has been tracking the virus' genetic code and spread.

Fischer isn't willing to give up her theory. "When you're thinking about how this thing spread so fast," the 63-year-old says, "it couldn't have just gotten here in December."

Bendavid, the Stanford professor, said one person who wrote to him believed they caught the virus in 2018. "That, I think, is stretching it," says Bendavid.

Thinkihadititis usually involves stretching the imagination to some degree. After all, covid-19 shares some symptoms with the seasonal flu and common allergies. Currently fewer than 20 percent of covid-19 tests are coming back positive, according to data reported to the Centers of Disease Control and Prevention, suggesting that the great majority of people who thought they had it - even in the middle of the pandemic - didn't actually have it.

To the extent that having already beat covid-19 is preferable to wondering if you're one of the people it's going to put in the hospital, Thinkihadititis may be a form of positive thinking. Humans are hardwired to anticipate positive outcomes, says Tali Sharot, a professor of cognitive neuroscience at the University College London who studies optimism and expectations.

"When there is something we want to believe, we are very good at interpreting the evidence in a way that would support that belief," says Sharot.

The reverse is also true. "Say there was a doctor saying that if you had it before, then the likelihood that you would get it again is higher, and it would be even more dangerous," says the professor. If that were the case, people "would probably look back to their illnesses and interpret certain symptoms as definitely not covid-19."

Whether it's a comfort or a source of anxiety, Thinkihadititis represents a state of limbo.

The good news? There's a cure.

Kind of.

- - -

"The only way to know is to get an antibody test," says Rachael Ayscue. "And I don't know anywhere around here that'll give one."

Ayscue, 47, lives in the suburbs of Raleigh, North Carolina. On Jan. 6, she felt sick, and before long she was coughing so much that it sometimes hurt to breathe. Then her daughter got sick, too. Raleigh didn't see its first confirmed covid case until March 3, but Ayscue wondered whether the tech workers of the Research Triangle had traveled to Asia over the holidays, and brought the virus back. (Epidemiologists believe the earliest American cases originated in Europe, not Asia.)

Antibody tests may provide relief from the fever of doubt. Also known as serology tests, they determine whether a patient's blood contains antibodies, which are proteins that help us fight off infection. The presence of antibodies means the patient's immune system has already been exposed to the virus.

Those tests are now becoming available nationwide, although experts warn that their accuracy can vary.

Since it began offering appointments for antibody tests, the telemedicine provider PlushCare saw "a pretty overwhelming response (from) people who are interested," especially in harder-hit areas like New York, says James Wantuck, the platform's chief medical officer and co-founder.

PlushCare's doctors remind patients that immunity is not a given and that they must continue social distancing and other protective measures. And if the tests come back negative, some patients - confident in their self-diagnosis and wary of possible testing inaccuracies - might not believe them.

"Some of the patients are certainly disappointed," says Wantuck. "I think everyone wants to have this in their rearview mirror or feel some sense of relief."

Fischer, the woman who got sick last September, says she couldn't be convinced so easily. "If I get tested," she says, "and I don't have the antibodies, I think I would ask for a different test."

Ayscue says she plans to get an antibody test if she can, but she doesn't need one to feel comfortable returning to life as usual. She does not hesitate to go to the grocery store, sometimes without a mask. She says she supports the protesters who have demonstrated against strict lockdown rules in North Carolina.

"I've chosen not to be afraid," she says.

Read more:
Why so many people are convinced that they had COVID-19 already - Chron.com

Middlefield Dr. Heng Wang, a board certified pediatrician and the Medical Director of the DDC Clinic located in Middlefield, OH, announced today that their Amish Genetic Disease Panel will now test for 160 rare conditions. This important tool allows faster diagnosis of unidentified genetic conditions at a reduced cost. DDC Clinic delivers personalized and life-changing medical care to special needs children affected by rare genetic disorders.

Were very excited to be able to now screen for an additional 40 conditions as part of this panel, said Dr. Wang. Early diagnosis leads to early treatments, and those effective treatments can be lifesaving.

Dr. Wang credited the hard work of his staff with bringing this project to fruition months ahead of schedule. This project was partially funded by the Elisabeth Severance Prentiss Foundation and the Fowler Family Foundation. Their support allows us to keep the cost of the new panel the same as the previous panel.

The improved Amish Genetic Disease Panel will be used in DDC Clinics collaboration with the Care Center in Middlefield. Parents of newborn infants at the birthing center can have a sample of their babys cord blood sent to DDC Clinic for analysis. Parents would then know if their child is affected by any of these 160 rare conditions. If a condition is identified, no additional testing would be needed and support services could be initiated early in the babys life. Thanks to our generous donors and the United Way of Geauga County, parents are asked to pay only $25.00 for this testing as part of their birthing fee.

The Amish Genetic Disease Panel has proven to be an important tool and is a great example of personalized medicine in action. It is a resource for doctors serving Amish and Mennonite patients in both Geauga County and neighboring communities.

Read the original post:
Amish Genetic Disease Panel created by DDC Clinic can now test for 160 rare conditions - The Weekly Villager

While researchers are working to advance drugs to treat COVID-19 and vaccines to give people immunity against the virus, the mental health impact of the pandemic will also have to be managed. This is where PGx testing may be most useful, experts in the field said.

"It is worthwhile to consider not just the utility of PGx in preventing hospitalization or changing the course of COVID-19 care," but also the impact it could have on managing "the burden on the patients that do survive a COVID-19 infection [and] those that are suffering from the isolation of social distancing, as well as the financial hardships," said David Thacker, a clinical pharmacogenetics content specialist at Translational Software.

According to a recent JAMA editorial, during the SARS outbreak in 2003, there was a greater incidence of post-traumatic stress syndrome and psychological distress among patients and doctors. In communities impacted by Hurricane Ike in 2008, around 5% of individuals met the criteria for major depressive disorder, while one in 10 adults in New York City had symptoms of the disorder after 9/11.

"In the context of the COVID-19 pandemic, it appears likely that there will be substantial increases in anxiety and depression, substance use, loneliness, and domestic violence; and with schools closed, there is a very real possibility of an epidemic of child abuse," wrote Sandro Galea from Boston University School of Public Health, Raina Merchant from the Perelman School of Medicine, and Nicole Lurie from the Coalition for Epidemic Preparedness Innovations in Norway.

A survey in March by the American Psychiatric Association found that more than a third of polled individuals said that the pandemic was seriously impacting their mental health, nearly half said they were scared about getting the virus, and 62% said they feared a loved one would get it. Meanwhile, calls to substance abuse and mental health help lines increased eightfold from February to March.

As the pandemic continues, people may increasingly turn to medications to deal with the psychological wounds left by the pandemic. Drugs to treat mental health conditions, including major depressive disorder, are some of the most widely prescribed drugs in the U.S., but they're also highly variable and associated with unwanted side effects.

As such, one of the main areas where PGx testing has seen uptake is for personalizing psychiatry drugs. Myriad Genetics recently published a meta-analysis involving more than 1,500 patients with major depressive disorder who were enrolled in four studies, which showed that patients who received treatment based on PGx information had significantly better outcomes than those who did not.

Although PGx testing in psychiatry is not without its naysayers, doctors may reach for such testing if the use of mental health drugs increases during or after the pandemic. Genomind, a mental health-focused PGx testing company, recently took a number of steps to make it easier for physicians to deliver psychiatric care during the pandemic. Doctors can order Genomind's PGx test and send a saliva collection kit to patient's homes, which can then be mailed to the lab for analysis. Through Genomind, doctors also have access to Sharecare's HIPAA-compliant telemedicine platform for free until September, which they can use to remotely see patients and discuss PGx test results, if ordered.

"The utility of PGx during the COVID-19 crisis is more important than ever," a spokesperson for the company said. "This service is helping enable critical mental health treatment during the pandemic and Genomind is doing its best to enable as many mental health professionals as possible."

This story first appeared in our sister publication, Genomeweb.

Read the rest here:
Drug-gene testing could give experts insight into COVID-19 treatment - ModernHealthcare.com

For a few years now, scientists at Washington University have been working on techniques to turn stem cells into pancreatic beta cells as a way of addressing insulin shortages in diabetics. After some promising recent strides, the team is now reporting another exciting breakthrough, combining this technique with the CRISPR gene-editing tool to reverse the disease in mice.

The pancreas contains what are known as beta cells, which secrete insulin as a way of tempering spikes in blood-sugar levels. But in those with diabetes, these beta cells either die off or dont function as they should, which means sufferers have to rely on diet and or regular insulin injections to manage their blood-sugar levels instead.

One of the ways scientists are working to replenish these stocks of pancreatic beta cells is by making them out of human stem cells, which are versatile, blank slate-like cells that can mature into almost any type of cell in the human body. The Washington University team has operated at the vanguard of this technology with a number of key breakthroughs, most recently with a cell implantation technique that functionally cured mice with diabetes.

The researchers are continuing to press ahead in search of new and improved methods, and this led them to the CRISPR gene-editing system, which itself has shown real promise as a tool to treat diabetes. The hope was that CRISPR could be used to correct genetic defects leading to diabetes, combining with the stem cell therapy to produce even more effective results.

As a proof of concept, the scientists took skin cells from a patient with a rare genetic type of diabetes called Wolfram syndrome, which develops during childhood and typically involves multiple insulin injections each day. These skin cells were converted into induced pluripotent stem cells, which were in turn converted into insulin-secreting beta cells. But as an additional step, CRISPR was used to correct a genetic mutation that causes Wolfram syndrome.

These edited beta cells were then pitted against non-edited beta cells from the same batch in test tube experiments and in mice with a severe type of diabetes. The edited cells proved more efficient at secreting insulin and when implanted under the skin in mice, reportedly caused the diabetes to quickly disappear. The rodents that received the unedited beta cells remained diabetic.

This is the first time CRISPR has been used to fix a patients diabetes-causing genetic defect and successfully reverse diabetes, said co-senior investigator Jeffrey R. Millman. For this study, we used cells from a patient with Wolfram syndrome because, conceptually, we knew it would be easier to correct a defect caused by a single gene. But we see this as a stepping stone toward applying gene therapy to a broader population of patients with diabetes.

The researchers are now continuing to work on improving the beta cell production technique, which in the future could involve cells taken form the blood or even urine, rather than the skin. They believe that further down the track this therapy could prove useful in treating both type 1 and type 2 diabetes, by correcting mutations that arise from genetic and environmental factors, and possibly be used to treat other conditions, as well.

We basically were able to use these cells to cure the problem, making normal beta cells by correcting this mutation, said co-senior investigator Fumihiko Urano. Its a proof of concept demonstrating that correcting gene defects that cause or contribute to diabetes in this case, in the Wolfram syndrome gene we can make beta cells that more effectively control blood sugar. Its also possible that by correcting the genetic defects in these cells, we may correct other problems Wolfram syndrome patients experience, such as visual impairment and neurodegeneration.

The research was published in the journal Science Translational Medicine.

Source: Washington University

See more here:
CRISPR combines with stem cell therapy to reverse diabetes in mice - New Atlas

TBTAK has invested TL 2.3 billion ($ 300 million) for the development of 16 vaccine and other medicine projects over the past five years in Turkey, the president of the Scientific and Technological Research Council of Turkey (TBTAK) said Saturday.

A platform consisting of 41 Turkish institutions has mobilized to develop medicines and vaccines against COVID-19 pandemic, professor Hasan Mandal noted, adding that efforts to develop anti-coronavirus drugs and vaccines were launched late December in coordination with the Ministry of Industry and Technology and proposals to be carried out within a 9 to 12 month period were taken into account and evaluated.

There are 16 projects working in synergy both in medicine and vaccine groups thanks to the COVID-19 Turkey Platform, which includes 225 researchers from 25 universities, eight public research bodies and eight private firms, Mandal added.

For medicine in pre-clinical phases, we'll be in the production phase this summer, probably much earlier. For vaccine, pre-clinical phase will be completed within a nine-month period, Mandal said. He added that it is now time for institutions cooperating with the science body to prove their valor.

The modeling of molecules in the medicine group began with the identification of over 10,026 molecules that could provide a solution for this virus, Mandal explained, adding synthesis works regarding this and its production are now underway.

In order to fight with a virus that you recently came across, you have to know it and define it correctly. All proceeding phases are tied to this. For that, it should be isolated from all external conditions and genetic characterization of the virus should be carried out. We will have genetic characterization of this virus determined next week. This situation shows the competence of this country. We now know this virus and this will be among the most important indicators how we will fight it both on the medicine side and vaccine side, Mandal said.

Read more:
Turkey's top scientific body invests TL 2.3 billion on 16 vaccine projects over 5 years | Daily Sabah - Daily Sabah

Researchers identify molecular markers that can help in developing better varieties of black pepper

Dubbed as the 'king of spices', black pepper has a lot to offerwhether as a flavouring agent or as a traditional medicine to relieve common cold, chest congestion or sore throat. A vital ingredient in many cuisines, it is the only spice that finds its way on nearly everything on the dining table. Piperine, a chemical in the black pepper, gives it a sharp taste. It is a native plant of the Western Ghats, and the crop is of immense agronomic value in today's world trade. However, insufficient genomic resources pose as main barriers in cultivating disease-resistant varieties of this master spice.

In a recent study, researchers from ICAR-National Bureau of Plant Genetic Resources, New Delhi, have identified a type of DNA sequence, called Simple Sequence Repeats (SSRs), which aims to ease and promote the genetic analysis of black pepper. The findings of the study, published in the journal PLoS ONE, could lead to enhanced productivity with better traits of the plant.

Simple Sequence Repeats, also called microsatellites, are repeating stretches of DNA that contain one to six nucleotide bases, and are randomly present throughout the genome. These can be passed from one generation to the next. Hence, they are used as a 'signpost' to keep track of a gene of interest. They play critical roles in genetic studies and plant breeding. The location of these SSRs in the genome remain the same in related species, thus enabling cost-effectiveness of similar studies on them.

Unlike other commercial crops like watermelon, cotton or finger millets, very few genetic studies have been done on black pepper, due to lack of resources. Although the Western Ghats harbours the maximum genetic diversity of black pepper, it remained "largely untouched from genomic interventions," say the researchers. The identification of cross-species SSRs will save time, effort and resources in the development of SSRs in these species, and aid future genetic and evolutionary studies.

The researchers first sequenced the entire genome isolated from the leaf samples of black pepper (Piper nigrum) and then scanned it for the presence of SSRs. The genome was then amplified with a method called Polymerase Chain Reaction, using short nucleic acid sequences called primers, designed to identify the right SSRs. The researchers compared the results of their analysis in thirty different types of black pepper. The researchers also explored ten species of Piper (including P. nigrum) for the presence of these SSRs by looking at an online database of the genetic sequence.

In all, 69,126 SSRs were identified in the study, with the majority of SSRs composed of two nucleotide repeatsthymine and adenosine (TA). Out of 85 primers, 74 produced the required results of appropriate-sized SSRs. Genetic diversity study of the thirty cultivars reported four distinct groups. A few SSRs were found in closely-related species, implying that they could be used in studying other species of black pepper with limited genomic knowledge.

The current study seeks to fill the void in genomic knowledge of black pepper species by identifying easy-to-detect molecular markers to enable its genetic and breeding studies. The SSRs, which indicate the location of a gene related to the desired trait, can help in choosing the right plants for breeding experiments, which is otherwise a difficult activity.

"The genomic microsatellite markers identified in black pepper in this study would form valuable and long-awaited resources for researchers and plant breeders", say the researchers.

The findings can also be used for diversity studies, linkage mapping, evolutionally biology, DNA fingerprinting and trait association shortly.

Originally posted here:
Paparazzi on the black pepper - Research Matters

As many people yearn to return to some form of normalcy, states are beginning to consider what the reopening of nonessential businesses should look like. In his daily press briefing Gov. Andrew Cuomo (D-N.Y.) said a crucial first step for reopening is widespread COVID-19 testing which New York State currently lacks.

On that same day, Dr. Augustine M.K. Choi, Weill Cornell Dean, announced a new initiative to begin antibody testing employees of Weill Cornell.

Current testing efforts across the state are focused on detecting those with the SARS-CoV-2 virus, but in order to begin reopening businesses people must be tested for previous exposure to the virus.

The current diagnostic used to test patients suspected of having COVID-19 at WCM is a real time reverse transcription polymerase chain reaction, an effective and relatively fast method to detect genetic material. It can be used to detect the RNA present in the SARS-CoV-2 virus.

PCR is the gold standard because its such a highly sensitive and specific test and can deliver reliable and accurate diagnosis in as fast as 2-5 hours. Compared to other available platforms its much faster and more accurate, said Dr. Melissa Cushing, pathology, in Chois update.

However, as institutions begin to test for people who were exposed to the virus and recovered, another method is required antibody testing. Instead of testing for the genetic material of the virus itself, antibody tests search for the antibodies that the body creates in response to COVID-19. These antibodies are formed between three and 15 days after experiencing symptoms, according to Cushing.

As of April 17, testing was made available for New York Presbyterian staff that tested positive for COVID-19 or had a COVID-19-like illness and returned to work.

WCM plans to make more testing available to its staff, as it works to increase its testing capabilities. Cushing predicted that this public testing is at least several weeks away. Experiencing the brunt of statewide shortages of certain materials, WCM also requires access to reagents and more high output platforms to increase its testing capabilities.

We need to really scale up with the amount of reagents we have with our current tests. Then we are really looking to some of the commercial labs to provide the large, high frequency platforms that we already use in our labs so that the process can be much more automated, Cushing said. That is our goal to be testing as many people that need to be tested in our city.

In order to address the testing insufficiencies on a statewide level, the governor issued an executive order on April 17 that directs all public and private labs capable of conducting virology testing to coordinate with the State Department of Health to prioritize coronavirus testing.

The testing and tracing is the guideposts through this. As we are working our way through the next several months the testing, which is informing us as to who can go back to work helping us isolate people, its about testing, Cuomo said in his daily briefing on April 17. Testing is a totally new challenge. Nobody has done this and what we need to do on testing.

According to Cuomo, the lack of infrastructure to facilitate widespread testing mirrors the earlier lack of coordination between hospitals, which the Surge and Flex initiative addressed the initiative coordinated the distribution of scarce medical supplies between public and private hospitals across the state.

Besides the lack of infrastructure, another impasse to wide scale testing is the availability of the materials specifically chemical reagents necessary to run the tests.

Currently, this order will not affect the labs on Cornells Ithaca campus.

Cornell University is not offering any human testing for COVID-19 on campus at this point. We will always follow all state/federal government regulations as appropriate, John Carberry, a University spokesperson, wrote in a statement to The Sun.

Cornell is affiliated with two of the 301 laboratories and hospitals capable of performing viral testing the Allyn B Ley Clinical Laboratory housed in Cornell Health and the Hospital for Special Surgery Dept of Pathology and Laboratory Medicine in New York City.

Initially, 28 laboratories with clinical laboratory permits from the state health department and experience in molecular-based virology could conduct testing. However, this system is unable to meet the demand for the widespread testing needed to reopen New York State.

We dont have a testing system that can do this volume, or that can be ramped up to do this volume. We dont have a public health testing system, its de minimis if you look at what our government department of health have, Cuomo said.

The state has begun its efforts to perform antibody tests on 3,000 individuals to better understand what percentage of the population is currently immune to the virus. The plan is being supported financially by former New York City mayor Michael Bloomberg, who pledged more than $10 million to create a test and trace program.

See original here:
As Cuomo Issues New Executive Order, Weill Cornell Medicine Ramps Up COVID-19 Testing - Cornell University The Cornell Daily Sun

Many people dislike drug companies. Drug companies often charge a lot of money for their products. Sometimes their drugs dont work. Sometimes they have side effects. Sometimes they are addictive. Even the best drugs wont keep us alive forever.

But, during the coronavirus pandemic, we are relying on drug companies and other healthcare companies to save our lives and the lives of our loved ones.

While government plays a vital role in managing the response to the COVID-19 pandemic, its the private sector that will provide the solutions to identify and fight the disease. Who would you rather depend on profit-making private companies or bureaucratic government agencies?

The CDC response

In the United States, the Centers for Disease Control, a federal agency, was initially tasked with providing tests for COVID-19. Its test kits could not detect the difference between COVID-19 and lab-grade water.

The CDC also limited testing to patients who had recently traveled to China and were symptomatic. Whoops!

The lack of reliable test kits enabled the disease to spread throughout the United States. The U.S. Food and Drug Administration determined on Feb. 29 that certified labs, including commercial lab testing companies, could develop and distribute COVID-19 test kits.

Private companies and clinics stepped up quickly. Some examples:

The Cleveland Clinic developed an eight-hour test kit.

Hackensack Meridian Health developed a rapid response test kit that can provide results within a few hours.

On March 23, Everlywell became the first company to offer a test kit that consumers can use at home.

Roche shipped 400,000 test kits to labs across the United States beginning March 13, and an additional 400,000 the following week.

Thermo Fisher Scientific developed a test kit that can detect COVID-19 within four hours.

Drug companies in the United States and throughout the world are also working to develop a vaccine to fight COVID-19.

Cambridge-based Moderna Inc. has already begun Phase 1 testing of its mRNA-1273 vaccine that is based on the genetic sequence of COVID-19. Regeneron Pharmaceuticals of Tarrytown, New York, is working on an antibody treatment that uses the virus to build up antibodies that fight COVID-19. Inovio Pharmaceuticals of Plymouth Meeting, Pennsylvania., is developing INO-4800, a vaccine similar to Modernas that is made from optimized DNA plasmids.

But thats just a sample. At least 16 U.S. pharmaceutical companies are working on vaccines for COVID-19.

The government has been doing its part. President Trump declared a national emergency and Congress has been negotiating a massive spending bill, while the Federal Reserve Board dropped interest rates back to zero, resumed bond buying and provided liquidity to the banking system. None of these actions reassured investors and stopped the stock market from tanking. Recall that during the financial crisis, the Obama Administration invested more than $800 billion in a stimulus that stimulated the federal debt, but not the economy.

Communism vs. capitalism

While the government and private sector have both been working hard to battle the coronavirus, the Chinese government has been working hard to preserve the Communist Party by blaming the United States for the pandemic.

When Wuhan doctor Li Wenliang warned his colleagues in late December about a possible coronavirus that resembled SARS, local police reprimanded him for spreading rumors and he was called before a disciplinary council of the local Communist Party and forced to repent and confess, in writing, that he had spread rumors harmful to the glory of the Party, according to City Journal.

In early January, news of the virus started circulating on Chinese social media accounts. The government responded by shutting them down. By silencing news about the outbreak of COVID-19, Communist leaders allowed it to spread, resulting in the pandemic and thousands of deaths that could have been avoided.

Xu Zhiyong, an activist who criticized Chinese President Xi Jinpings response to the coronavirus, was jailed for subversion. Journalists Li Xehua, Fang Bin and Chen Qiushi, who tried to inform the public about the coronavirus outbreak, are all missing. And Western journalists who brought these stories to the worlds attention have been expelled from China.

Wuhan activists, professors and lawyers who had asked for President Xis resignation have all virtually disappeared. In addition to stifling the news at home, Chinas leaders failed to inform other countries about the severity of the coronavirus or to prevent its spread outside of China.

Should China be paying reparations to the rest of the world? Should it at least admit its guilt and apologize? According to an editorial in state-run media agency Xinhua, We should say righteously that the U.S. owes China an apology, the world owes China a thank you.

In addition, while the United States has shipped medical supplies to China to help fight the outbreak, China is threatening to impose export controls on pharmaceuticals needed by the U.S. to fight COVID-19.

In an article in Xinhua, Beijing bragged about its handling of COVID-19, according to Fox News. The article also claimed that China could impose pharmaceutical export controls which would plunge America into the mighty sea of coronavirus.

Without disclosing which drug or drugs are in short supply, the U.S. Food and Drug Administration announced a shortage of raw materials made in China that are needed to produce the drug.

While the United States is the world leader in medical research, China supplies 80% to 90% of antibiotics used in the United States, 70% of acetaminophen and about 40% of heparin, according to Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations.

Government vs. private sector

In other countries where health care is socialized, such as Italy and the United Kingdom, government responses have been underwhelming and politically charged.

Some 4,032 have died in Italy, more than in China, with 627 Italian deaths reported Friday (March 20) the highest daily toll for any country so far, according to The Wall Street Journal.

Which brings us back to the United States, where many Americans believe we would be better off with a socialized healthcare system. After all, many other countries have socialized medicine.

Some believe we should have price controls on drugs. Others believe that drug companies should not make profits and should make life-saving drugs available at no cost.

That belief would lead to no more life-savings drugs being developed, because there would be no incentive for companies to do so. Even if companies wanted to be able to give away free drugs, doing so would quickly put them out of business. Jobs would be eliminated and their stock would become worthless.

The average cost to develop a new drug is $2.6 billion. Post-approval research and development costs, such as the cost of monitoring effectiveness and safety, average $312 million and boost the total cost for each approved drug to almost $3 billion.

Most drugs never make it to market. Only about 12% of drugs that enter clinical testing are eventually approved for public use.

Some drug companies have made a great deal of money. Some have taken advantage of the drug-approval process and charged outrageous prices for their products.

Weve all heard about companies like Theranos, which achieved a valuation of $9 billion based on fraudulent blood-testing technology, or Mylans price gouging for its EpiPen. Companies in any industry that take advantage of their customers usually pay in the end, but in such cases, government involvement is necessary.

Regardless, even with no vaccine yet available, special interest groups that pretend that their interest is our interest are calling for President Trump to prohibit profiteering by Big Pharma during the coronavirus pandemic.

If Big Pharma develops a vaccine that works, the company that does so should make a significant profit. Is there a sector more deserving of a profit than one that saves lives? While small businesses are suffering most during the pandemic, large companies have also had to deal with major losses, a huge drop in their stock price and mounting expenses in an attempt to staunch the bleeding.

In 1900, 37% of all American deaths were from infectious diseases, George Will wrote. Today the figure is 2%.

Id rather the drug companies get a cut of my hard-earned money than the more than 70 groups that are trying to stop them from earning a profit. To my knowledge, none of the 70 groups has criticized President Xi.

Brenda P. Wenning of Newton is president of Wenning Investments LLC in Newton. She can be reached at Brenda@WenningInvestments.com or 617-965-0680. For additional information, visit her blog at http://www.WenningAdvice.com.

Link:
Drug companies are the good guys - MetroWest Daily News

CLAIM

"this coronavirus genome contained sequences of another virus [] the HIV virus (AIDS virus)"

DETAILS

Inaccurate: Genomic analyses indicate that the virus has a natural origin, and was not engineered. The so-called unique protein sequence insertions found in the 2019 novel coronavirus can be found in many other organisms, not just HIV.

KEY TAKE AWAY

Genomic analyses of the novel coronavirus show that it was not engineered. In addition, the claim that its genome contains inserted HIV sequences is based on a now-withdrawn preprint of a study that contained significant flaws in design and execution. The so-called HIV insertions identified by the authors are in fact gene sequences that can also be found in many other organisms besides HIV.

REVIEW Numerous articles published in April 2020 report that Nobel laureate Luc Montagnier claimed that SARS-CoV-2 is a manipulated virus that was accidentally released from a laboratory in Wuhan, China and that Indian researchers have already tried to publish the results of the analyses that showed that this coronavirus genome contained sequences of another virus [] the HIV virus (AIDS virus). The claim that SARS-CoV-2 contains HIV insertions began circulating in January 2020, and was propagated by outlets such as Zero Hedge and Infowars. Health Feedback covered this claim in early February 2020, and found it to be inaccurate.

Firstly, genomic analysis of the novel coronavirus, published in Nature Medicine, has demonstrated that the virus is not the product of bioengineering, but is rather of natural origin[1]. The current most likely theory, based on what scientists know about viral evolution, is that the virus first emerged in pangolins or bats (or both) and later developed the ability to infect humans. This ability to infect human cells is conferred by the so-called spike (S) protein, which is located on the surface of the enveloping membrane of SARS-CoV-2.

After the 2003-2005 SARS outbreak, researchers identified a set of key amino acids within the S protein which give SARS-CoV-1 a super-affinity for the ACE2 target receptor located on the surface of human cells[2,3]. Surprisingly, the S protein of the current SARS-CoV-2 does not contain this optimal set of amino acids[1], yet is nonetheless able to bind ACE2 with a greater affinity than SARS-CoV-1[4]. This finding suggests that SARS-CoV-2 evolved independently and undermines the claim that it was manmade[1]. Indeed, the best engineering strategy would have been to harness the known and efficient amino acid sequences already described in SARS-CoV-1 order to produce a more optimal molecular design for SARS-CoV-2. The authors of the Nature Medicine study[1] concluded that Our analyses clearly show that SARS-CoV-2 is not a laboratory construct or a purposefully manipulated virus.

Secondly, the claim that SARS-CoV-2 contains HIV insertions is based on a preprint of a research study uploaded to bioRxiv on 2 February 2020. A preprint is a study in progress that has not been peer-reviewed by other scientists. The authors of the preprint, titled Uncanny similarity of unique inserts in the 2019-nCoV spike protein to HIV-1 gp120 and Gag, claimed to have found 4 insertions in the spike glycoprotein (S) which are unique to 2019-nCoV and are not present in other coronaviruses. The authors further asserted that all of [these inserts] have identity/similarity to amino acids residues in key structural proteins of HIV-1 [which] is unlikely to be fortuitous in nature.

The work was swiftly criticized by experts. In this Forbes article, Arinjay Banerjee, a postdoctoral fellow at McMaster University who has studied coronaviruses, said that:

The authors compared very short regions of proteins in the novel coronavirus and concluded that the small segments of proteins were similar to segments in HIV proteins. Comparing very short segments can often generate false positives and it is difficult to make these conclusions using small protein segments.

Researchers also took to Twitter to demonstrate this problem first-hand. Trevor Bedford, a faculty member at the Fred Hutchinson Cancer Research Center who studies viral evolution, re-analyzed the gene and protein sequences used by the authors and found that the so-called unique inserts appeared in many other organisms, including Cryptosporidium and Plasmodium malariae, which cause cryptosporidiosis and malaria, respectively.

Assistant professor at Stanford University Silvana Konermann also checked the authors findings and came to the same conclusion, calling the similarity spurious.

This has also been independently confirmed in another published analysis[5]. In other words, these sequences are not insertions, but are rather common sequences found in numerous other organisms such as bacteria and parasites. Therefore, the existence of these sequences in SARS-CoV-2 does not provide evidence of a link to HIV, nor that scientists purposely inserted HIV sequences into the SARS-CoV-2 genome.

In summary, genomic analysis of the virus indicates that it does not contain so-called HIV insertions and that it was not engineered in a lab. Evidence points to the virus having a natural origin.

The only thing accurate about these articles is that Nobel Prize winner and virologist Luc Montagnier did in fact make these claims. Although he holds impressive scientific credentials, his claims run contrary to credible scientific evidence. And despite having won the Nobel Prize in Physiology or Medicine in 2008 for his co-discovery of the link between HIV and AIDS, Montagnier now promotes widely discredited theories such as the pseudoscience of homeopathy and that autism is caused by bacteria that emit electromagnetic waves. Articles which repeat Montagniers claims without critically evaluating their veracity exhibit the common appeal to authority fallacy, in which something is assumed to be true simply because the person saying it is considered to be an expert, thereby misleading readers into believing that this theory is scientifically credible. This demonstrates the importance of verifying scientific claims with other experts in the same field, rather than simply taking such claims from a single expert at face value.

SCIENTISTS FEEDBACK [These comments come from an evaluation of a related claim.] Aaron T. Irving, Senior Research Fellow, Duke-NUS Medical School:Its easier to believe misinformation when it is mixed with truth. The region highlighted in the pre-print is indeed an insertion in nCoV-2019 relative to its bat ancestors and indeed it has high identity to the HIV gp120/gag. However, the authors chose to align only this small region and not do a basic check on whether there were other sequences which were also homologous (showing high degree of similarity/identity). As it turned out, the region is also homologous to many unrelated sequences. As such, the conclusions drawn from the data are no longer valid and there are many open-ended questions regarding this region highlighted. I see the authors themselves agree with this criticism by other scientists and have voluntarily withdrawn their preprint pending a much deeper investigation.

The author of this article by European Scientist also compared the genome sequences of SARS-CoV-2 and HIV using the Basic Local Alignment Search Tool (BLAST), developed by the U.S. National Institutes of Health, and found no significant similarity, explaining that In plain English, SARS-CoV-2 is not made of the bat coronavirus and small bits of the HIV virus. Readers who wish to verify the level of sequence identity between the two viruses for themselves are welcome to follow the steps listed in the article.

Here is the original post:
Nobel laureate Luc Montagnier inaccurately claims that the novel coronavirus is man-made and contains genetic material from HIV - Health Feedback

So when does the world get back to normal? It is a question that is on the mind of half of the worlds 7.8 billion people who have been asked to stay put at home to avoid a virus that has made millions sick. Not until a good vaccine is developed, Dr Anthony Fauci, Americas top infectious diseases expert, told reporters recently at a White House press briefing.

In normal times, experts say developing an effective vaccine would take anywhere between five and 10 years. But these are unprecedented times, and even scientists are being compelled to find newer ways to develop and test vaccines. Best-case scenarios for vaccine development have already shrunk the time frame to 12 to 18 months; globally, more than 100 vaccine candidates are at different stages of development. Five of these have reached the Phase 1 trials, and 18 are in pre-clinical stage, said Dr Shahid Jameel, virologist and CEO, Wellcome Trust/DBT India Alliance.

Closer home, Indian scientists, researchers and vaccine manufacturers are racing ahead, after Prime Minister Narendra Modi, in his speech on April 14, asked Indias young scientists and researchers to come forward to work on a vaccine against Covid-19.

For those working on vaccines, what has helped, said Premas Biotech cofounder and managing director Prabuddha Kundu, is that regulatory pathways are being fast-tracked and regulators are now willing to consider new scientific processes, and collaborations are happening.

Bharat Biotech is collaborating with virologists at the University of Wisconsin-Madison and vaccine company FluGen on a unique intranasal vaccine called CoroFlu.

For a country that is a leading manufacturer and supplier of vaccines, India definitely has some advantages in building one. According to the department of biotechnology, the government body that is leading the hunt for the vaccine development, four major companiesSerum Institute of India, Zydus Cadila, Bharat Biotech, Biological E Ltdhave a candidate each, besides academic research groups from the Indian Institute of Science, International Centre for Genetic Engineering and Biotechnology, National Institute of Immunology, and Translational Health Science and Technology Institute.

Vaccines are built by taking different approaches, said Jameel. They can either use inactivated viruses (for instance, the injectable polio vaccine); or live attenuated or weakened virus (the oral polio vaccine built in the 1950s) that is weakened to the point that it infects and multiplies, but does not cause disease; or subunit vaccines, where you take a part of the virus (protein), produce en masse and purify it and use it as a vaccine. The idea is to choose the antigens that best stimulate the immune system. One method of production involves isolating the specific protein from the virus or producing it using recombinant DNA technology and then administering it on its own. This reduces the likelihood of adverse reactions to the vaccine. The hepatitis-B vaccine is one example of that approach, said Jameel. Besides, vaccines being developed are also either based on DNA, RNA, or vector vaccine-based approaches.

The selection of an antigen and the antigenic design of the potential candidate will have a profound effect in generating an effective immune response. Since spike protein of the SARS-CoV-2 is a potential target, one will need to decide whether full-length spike glycoprotein or part of the protein that binds with the receptor needs to be selected, said Professor Sunit K. Singh, head, molecular biology unit, faculty of medicine, Institute of Medical Sciences, Banaras Hindu University.

For now, Premas Biotech seems to have worked around some of those issues. The Gurugram-based company, in collaboration with US-based Akers Biosciences, is working on its vaccine candidate using a mixture of three antigens produced in bakers yeast. Its cofounder and managing director, Prabuddha Kundu, said that traditionally vaccines were made by injecting heat-killed or attenuated whole viruses or bacteria, but since that had side effects, the approach of late has been to take a part of surface proteins, purify and produce it recombinantly (by rearranging genetic material) to elicit an antibody response.

In the case of SARS-CoV-2, one of the top targets is the spike protein present on the outer surface of the virus, and is understood to be the weapon with which it binds to the human cells (receptors) and gains entry. But since there were concerns about mutations in spike proteins, Kundu said that his team had created a mixture of the spike protein and two other proteins found on the outer membrane of the virus. These, said Kundu, would be replicated on its genetically engineered platform of bakers yeast (D-CryptTM). The platform has worked in the past, tooit has been successful in expressing 30 proteins similar to those in the structure of the selected Covid-19 antigens. It is also safer, and cost-effective, said Kundu, adding that the company has applied for animal trials with the Review Committee on Genetic Manipulation.

In Hyderabad, Bharat Biotech is collaborating with virologists at the University of Wisconsin (UW)-Madison and vaccine company FluGen on a unique intranasal vaccine called CoroFlu. The new vaccine is being built on the backbone of the trios flu vaccine candidate known as M2SR, developed a couple of years ago. M2SR is a self-limiting version of the influenza virus that induces an immune response against the flu, said Dr Krishna Ella, chairman and managing director, Bharat Biotech. [FluGen cofounder Yoshihiro] Kawaokas lab will insert gene sequences from SARS-CoV-2 into M2SR so that the new vaccine will also induce immunity against the novel coronavirus.

CoroFlus safety and efficacy in animal models is being assessed at the UW-Madisons influenza research institute, said Ella, which could take four to six months. Post the results of animal trials, which is crucial, Bharat Biotech will begin production scale-up for safety and efficacy testing in humans. CoroFlu could be in human clinical trials by the fall of 2020, he said.

Bharat Biotech is also working on a second candidate that will utilise the inactivated rabies vector platform, for which funding has been approved by the department of biotechnology. The department has also recommended funding support to Ahmedabad-based Zydus Cadila for advancing the development of a DNA vaccine candidate, as well as Phase 3 human clinical trials for recombinant BCG vaccine (VPM1002) planned in high-risk population by the Pune-based Serum Institute of India (SII). SII is also testing its vaccine candidate (in collaboration with US-based biotech company Codagenix) on the animal models and hopes to have a vaccine by 2021, its CEO Adar Poonawalla has said.

Despite the urgency, there are challenges in making a vaccine for SARS-CoV-2, said Kundu. The tools that are normally available to us otherwise are not available here, he said. For instance, they did not have specific antibodies to test antigens. Despite that we have been able to work through this by developing surrogate models, he said.

The amount of time that the immunity lasts in the body is also something that is still not known. In the case of SARS-CoV and MERS infections, the natural immunity does not last long, said Singh. Based on that knowledge, one has to also decide the doses of vaccination to be given in order to have immunity for a long time. The challenge to produce in huge quantities to cover the population under a mass vaccination programme will also need to be taken on. That will require a global coalition, and not just a few companies.

For those working on vaccines, what has helped, said Kundu, is that regulatory pathways are being fast-tracked and regulators are now willing to consider new scientific processes, and collaborations are happening. For instance, two global vaccine manufacturersSanofi and GSKhave come together to develop an adjuvant vaccine for Covid-19. Sanofi is providing the antigen that will be produced on its Baculovirus Expression Vector System platform, said its spokesperson. The recombinant technology produces an exact genetic match to proteins found on the surface of the virus, the spokesperson told THE WEEK. GSK will provide its novel adjuvant technologyAS03.

An adjuvant is a substance that is combined with a vaccine antigen to help stimulate a stronger and more targeted immune response. This can help provide better protection or in some instances, like a pandemic, could reduce the amount of antigen required per dose, allowing more vaccine doses to be produced and supplied, said the spokesperson. This is a critical advantage in a pandemic setting. The AS03 adjuvant will help improve the immune response to the antigen and may also be antigen sparing. Due to the critical need for a vaccine to address Covid-19, Sanofi will be testing its own adjuvant as well.

According to Jameel, the challenge in building a vaccine against Covid-19 may not be any different from making a vaccine for other diseases. The power of technology available today is evident from the fact that since the pandemic began in January, we already have more than 100 candidates, he said. For India, the opportunity will be in manufacturing the vaccines that are developed eventually and making them affordable for all.

More here:
Team spirit - THE WEEK

WASHINGTON, April 15, 2020 /PRNewswire/ --Vanda Pharmaceuticals, Inc.(Vanda) (Nasdaq: VNDA) today announced the initiation of the CALYPSO program to study the role that human genetic variations play in SARS-CoV-2 ("COVID-19") infection and disease progression. As a part of the CALYPSO program, Vanda will collaborate with University of Washington School of Medicine and its Virology Lab on a pharmacogenetics study in patients with COVID-19. The study will focus on the sequencing of the genome of individual patients, as well as the COVID-19 virus, and the identification of genetic factors that correlate with disease progression and outcomes.

In support of this study, Vanda and UW Medicine plan to collect Whole-Genome Sequencing ("WGS") data from over 1,000 patients with COVID-19 infection, and perform Viral Genome Sequencing, which should enable Vanda and the UW Medicine Virology Lab to explore host susceptibility, associations of WGS with clinical outcomes and severity of disease, as well as host-virus interactions. The study is scheduled to begin enrollment in the coming weeks and will be open to patients in hospitals and clinics around the United States.

"We look forward to the advancement of our program and the opportunity to work with and leverage the expertise of UW Medicine to expand our understanding of the COVID-19 infection mechanism," said Mihael H. Polymeropoulos, M.D., President and Chief Executive Officer of Vanda.

"The study has the potential to provide new insights into virushost interactions that could lead to more effective public health strategies and the design and development of vaccines and therapeutics," said Sandra P. Smieszek, Ph.D., Head of Genetics at Vanda. "With the vast amount of data we expect to collect, the team will aim to discern the factors associated with severity and other critical, clinical characteristics of the infected individuals."

"By leveraging our sequencing expertise and capabilities in collaboration with Vanda, we will be able to provide the necessary insight for potentially life-saving solutions for patients," said Alex Greninger M.D., Ph.D., M.S., M.Phil., Assistant Professor, Laboratory Medicine, Assistant Director, Virology Division at the University of Washington School of Medicine. "We believe this collaboration will help answer critical questions and hopefully outcomes in the fight against COVID-19."

"We are grateful to collaborate with Vanda as we try to find better ways to care for people currently suffering from COVID-19, and as we develop plans for the next phase of the national response," said Keith R. Jerome, M.D., Ph.D., Head of Virology Division at the University of Washington School of Medicine. "The approach of combining host and viral genomics to identify the most promising treatments may serve as a model for future efforts around the world. This unique agreement positions UW Medicine and Vanda for potentially changing the course of the COVID-19 pandemic."

"This is the type of collaboration we need to bring solutions to patients suffering in this time of crisis," said Dr. Greninger. "We look forward to getting this important work underway."

About Vanda Pharmaceuticals Inc.

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com and follow us on Vanda's Twitter and LinkedIn.

About UW Virology

The UW Virology is one of nine divisions comprising the Department of Laboratory Medicine at the University of Washington School of Medicine. The UW Medicine Virology Clinical Laboratories perform diagnostic testing for a full range of human pathogens including respiratory viruses, herpes group viruses, HIV, hepatitis, and enteric viruses, and was one of the earliest providers of COVID-19 testing. The Division provides the highest quality patient care and serves as a model of excellence for clinical laboratories across the nation. Its UW Virology Lab is also recognized as a worldwide leader in virology research. UW Medicine Virology's research programs integrate the latest in computational, laboratory, and clinical research methods to advance the understanding of infectious diseases. Many past and current faculty members in the Virology Division have received prestigious awards recognizing their scientific achievements.

Vanda Contact:

AJ Jones IIChief Corporate Affairs and Communications OfficerVanda Pharmaceuticals Inc.202-734-3400

pr@vandapharma.com

UW Medicine Contact:

Susan GreggDirector, Media Relations206-616-6730

sghanson@uw.edu

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

Various statements in this release are "forward-looking statements" under the securities laws. These forward-looking statements include, without limitation, statements regarding the design, enrollment and anticipated findings of the CALYPSO program, the promotion of more effective public health strategies and the design and development of vaccines and therapeutics. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others: Vanda's ability to enroll patients for, and successfully conduct, the study described in this press release; the ability of Vanda, either alone or with its partners, to process the data collected and subsequently develop effective vaccines or therapeutics; the ability to obtain FDA approval of any such vaccines or therapeutics; and other factors that are set forth in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's annual report on Form 10-K for the fiscal year ended December 31, 2019, which is on file with the SEC and available on the SEC's website at http://www.sec.gov. Additional factors may be set forth in those sections of Vanda's annual report on Form 10-Q for the fiscal quarter ended March 31, 2020, to be filed with the SEC in the second quarter of 2020. In addition to the risks described above and in Vanda's annual report on Form 10-K and quarterly reports on Form 10-Q, other unknown or unpredictable factors also could affect Vanda's results. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved. All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

View original content:http://www.prnewswire.com/news-releases/vanda-pharmaceuticals-announces-initiation-of-calypso-to-study-the-role-of-genetic-variation-in-covid-19-infections-in-collaboration-with-university-of-washington-medicine-301041400.html

SOURCE Vanda Pharmaceuticals Inc.

Read the original:
Vanda Pharmaceuticals Announces Initiation of "CALYPSO" to Study the Role of Genetic Variation in COVID-19 Infections in Collaboration With...

As Americans yearn for a future with work, shopping and outings with friends, one concept may become a crucial prerequisite: the widespread use of antibody tests.

Antibody tests, also known as serology tests, are designed to detect the presence of antibodies proteins that are key elements of the bodys immune response to germs. Antibodies would be present in people who battled the coronavirus and recovered, as well as in people who had been exposed but whose infection was so mild that they didnt notice they were sick.

If someone has antibodies from exposure to the coronavirus, that person should have immunity to the virus, at least for a period of time. (More on that in a bit.) That means they can go out into the wider community without fear of getting sick themselves. Antibody tests could also be helpful for making staffing decisions in medical units treating coronavirus patients.

Anthony Fauci, a top federal official in the fight against the coronavirus, has floated the idea of "immunity certificates" based on antibody testing. "As we get to the point of considering opening the country, it is very important to understand how much that virus has penetrated society," Fauci said on CNN.

Its also a key element of Democratic presidential candidate Joe Bidens plan for reopening the country. And New York Gov. Andrew Cuomo has gone so far as to develop and start implementing an antibody testing system for New York State. "We cannot restart life as we knew it without testing," Cuomo has tweeted.

PolitiFact interviewed several experts about the promise and potential pitfalls of antibody testing.

What has been done so far?

The Food and Drug Administration has already granted an "emergency use authorization" for one particular antibody test manufactured by a company called Cellex. The FDA also green-lighted other tests for the market without the usual review process, as long as they are labeled with disclaimers that the agency has not fully reviewed them.

That enabled more than 90 tests to go to market, some from academic organizations and some from medical companies, according to Politico. The CDC itself is working to produce one. Researchers at Stanford University have produced one test, while Mount Sinais Icahn School of Medicine has produced another.

The key to developing antibody tests is to have an appropriate coronavirus protein, "because thats what antibodies recognize," said Elizabeth McNally, director of the Center for Genetic Medicine at Northwestern Universitys Feinberg School of Medicine.

The tests work by having some viral protein adhered to a surface, McNally said. "A persons blood sample is mixed with a virus protein and is tested for whether there is an interaction between antibodies in the persons blood and the antibody on the surface."

The good news is that many of the tests are not overly complicated, often requiring blood from a self-administered finger prick. Some have a turnaround time as rapid as 10 to 15 minutes.

How accurate are these antibody tests?

Thats the bad news: The tests so far have not been especially accurate.

In mid April, the FDA said the National Cancer Institute would start reviewing tests for accuracy. This move was welcomed by medical experts.

The United Kingdom has already pulled some tests for inaccuracy. Many antibody tests now being rolled out "may not be as accurate as wed like," FDA commissioner Stephen Hahn has acknowledged. Scott Becker, CEO of the Association of Public Health Laboratories, went so far as to label many of the tests "crappy," CNN reported.

"There is very limited data, almost none peer-reviewed, evaluating how well these tests perform," said Elitza S. Theel, director of the infectious diseases serology laboratory at the Mayo Clinic. "So its critical that laboratories carefully perform validation and verification studies to ensure that the test they are offering for clinical testing is accurate."

A key metric will be a tests "sensitivity," which refers to the percentage of positive tests that reflect genuine infections. "Anything less than 99% would mean too many cases in the population are wrongly identified, throwing off population estimates," said Theo Vos, a professor at the University of Washingtons Institute for Health Metrics and Evaluation.

Will antibodies actually confer immunity?

Scientists expect that a past infection will produce some immunity. But they arent entirely certain of it, and it remains unclear how long that immunity could last.

Generally speaking, the degree and duration of immunity from an infection varies depending on the germ in question. Immunity from common cold viruses last a few weeks; immunity from chickenpox can last decades. Many infectious diseases fall somewhere in between.

One hopeful sign is that an infection with the virus that causes SARS, which is similar to COVID-19, produces an antibody response for a year, maybe more. Thats not as long as some diseases, but it could buy time until a successful vaccine is produced, which experts say could happen within 12 to 18 months.

One unknown is whether that immune response from a past coronavirus infection is strong enough to actually preclude a new infection.

COVID-19 probably gives immunity to "most people, but we dont know for sure that is the case in every recovered COVID patient," said Angela Rasmussen, associate research scientist at the Center for Infection and Immunity at the Columbia University Mailman School of Public Health. "We dont know what levels of antibodies confer protection either, so we should not assume that just having antibodies guarantees that you have completely protective immunity. Theres still a lot more to learn."

What are some of the practical challenges of administering tests?

One practical concern is when to collect samples from individuals.

"We know it takes over a week in some cases to mount an immune response to the virus and to develop a detectable level of antibodies," Theel said. "The samples need to be collected at a certain time after symptom onset. Using samples collected too soon would lead to negative results simply because the patient hasnt developed an immune response to the virus yet."

By the same token, additional testing may be necessary to confirm that someone who is antibody-positive is no longer experiencing an active infection that can get others sick.

Another practical issue is where the test should be administered.

"We dont want to have people rushing to a doctors office or a hospital since that could actually worsen the spread of the virus," McNally said. "Some companies are producing small individual test kits which will produce a + or - result. Some of these tests will require a doctors order and some may become commercially available."

For instance, McNallys institution, Northwestern University, is developing a kit that is designed to be sent through the mail. Once returned via mail with a blood drop on specially treated paper, the tested individual can find out their result a few days later through a secure website.

What can antibody testing tell us about society at large, rather than just the individual?

Knowing how many people are immune will be a key element of the decision to reopen the economy. However, undertaking society-wide testing will require coordinated effort.

Already, some studies are under way. The World Health Organization is working on a study of a half-dozen nations, while one effort in the U.S. is already collecting blood samples in such cities as New York, Seattle and Minneapolis. Other studies are occurring in Michigan, Miami and Los Angeles.

One study completed in a hard-hit town in Germany recently found that 14% of those tested had antibodies to coronavirus.

McNally said research studies like these are important because they "allow us to be able to know how the population has developed immunity. We will want to know what percentage of the population has developed antibodies and how this differs across neighborhoods and areas. This is the type of information that will help to guide decisions about bringing people back to work and future safety issues."

What needs to be done to enable large-scale antibody testing?

Vos recommends focusing on a small number of the most promising tests, then scaling up production. The expected high demand for antibody tests should help push companies to do this quickly, he said. In the meantime, he said, poorly performing tests should be restricted and the FDA should accelerate its regulatory process.

"Things are happening quickly, but without strong oversight there will be a flood of undocumented tests in use, muddying the waters for anyone trying to make sense of what is going on in the community," Vos said.

Its also important to note that antibody tests are just one part of whats needed to restart the economy. Experts say it will also require a system of widely available diagnostic tests to determine if someone has an active coronavirus infection, along with "contact tracing," a method of identifying people who were in close proximity to other people who were infected, so that they can be tested and, if necessary, quarantined.

CDC director Robert R. Redfield told NBC News that large-scale antibody testing could fall into place "over the next several months."

McNally told PolitiFact that she expects antibody testing to be ramping up in May.

"We know most people take about four weeks to develop antibodies and immunity, so assuming exposure to the virus occurred in March or April, we really want testing working at scale in May," she said. "I think were on target for that."

Link:
Antibody testing: The promise and pitfalls of using them to reopen the US - PolitiFact

NEW YORK and BASEL, Switzerland, April 15, 2020 (GLOBE NEWSWIRE) -- Axovant Gene Therapies Ltd., a clinical-stage company developing innovative gene therapies for neurological diseases, today announced its collaboration with Invitae, a leading medical genetics company, in the Detect Lysosomal Storage Diseases (Detect) program to facilitate faster diagnoses for children with lysosomal storage disorders (LSDs), including GM1 gangliosidosis and GM2 gangliosidosis, also known as Tay-Sachs/Sandhoff disease. Invitae offers genetic testing and counseling at no charge to patients suspected of having an LSD.

Axovant is committed to developing novel gene therapies for those living with rapidly progressive neurodegenerative diseases. We are hopeful that our collaboration with Invitae will provide families with easier access to genetic testing and bring us one step closer to identifying patients who may benefit from potential therapies, said Parag Meswani, PharmD., Axovants SVP of Commercial Strategy & Operations. Our AXO-AAV-GM1 clinical program targeting GM1 gangliosidosis is currently enrolling at the National Institutes of Health, and we are seeking IND clearance for the AXO-AAV-GM2 clinical trial targeting Tay-Sachs and Sandhoff diseases. Early intervention is ideal with potentially disease-modifying genetic therapies, and our diagnostics partnership with Invitae should allow us to identify and enroll children at even earlier stages of disease progression.

LSDs are progressive, multi-system, inherited metabolic diseases associated with premature death, and genetic testing is a crucial first step to arriving at a diagnosis. LSDs are misdiagnosed or undiagnosed in the majority of patients. The Detect program includes a specific LSD testing panel of 53 genes designed to provide patients and families accurate information quickly to preserve valuable treatment time.

Genetic testing can expedite an accurate diagnosis, facilitate earlier interventions, allow genetic counseling of family members, and support clinical research for LSDs such as GM1 and GM2 gangliosidosis, said Robert Nussbaum, M.D., chief medical officer of Invitae. Were pleased Axovant has joined the Detect program to help offer no-charge, sponsored genetic testing for those patients suspected of having the disease.

Research has shown no-charge testing programs with large well-designed panels help increase utilization of genetic testing, which can shorten the time to diagnosis by as much as 2 years in some conditions. Accurate diagnoses enable clinicians to focus on providing disease-specific care sooner, helping reduce costs and improve outcomes.

Additional details, as well as terms and conditions of the program, can be found at https://www.invitae.com/en/detectLSDs/.

About Axovant Gene Therapies

Axovant Gene Therapies is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurodegenerative diseases. Our current pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2 gangliosidosis (including Tay-Sachs disease and Sandhoff disease), and Parkinsons disease. Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations. For more information, visit http://www.axovant.com.

About Invitae

Invitae Corporation (NVTA) is a leading medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website atinvitae.com.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "might," "will," "would," "should," "expect," "believe," "estimate," and other similar expressions are intended to identify forward-looking statements. For example, all statements Axovant makes regarding costs associated with its operating activities are forward-looking. All forward-looking statements are based on estimates and assumptions by Axovants management that, although Axovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Axovant expected. Such risks and uncertainties include, among others, the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the expectations for regulatory submissions and approvals; the continued development of its gene therapy product candidates and platforms; Axovants scientific approach and general development progress; and the availability or commercial potential of Axovants product candidates. These statements are also subject to a number of material risks and uncertainties that are described in Axovants most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on February 10, 2020, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Axovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Story continues

Media Contact:

Parag MeswaniAxovant Gene Therapies(212) 547-2523investors@axovant.commedia@axovant.com

Follow this link:
Axovant Announces Partnership with Invitae to Increase Access to Genetic Testing and Accelerate Diagnoses of GM1 and GM2 Gangliosidosis - Yahoo...