Archive for the ‘Genetic Testing’ Category

Apr 2nd 2020

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WHEN A NEW virus invades the human body, the immune system leaps into action. First to the scene are antibody molecules of a type called immunoglobulin M (IgM). These bind with proteins on a viruss surface, disabling it and marking it for destruction by cells called macrophages. A few days later the system produces a second type of antibody, immunoglobulin G (IgG), to continue the fight. IgMs are short-lived. They stick around in the bloodstream for three or four weeks before disappearing. IgGs, however, are the basis for a much longer-term form of immunity. This can last for many years, or even a lifetime.

Kits that test for these two types of antibodies when they have been raised specifically by SARS-CoV-2 should soon become available. The virus causing the covid-19 is already being detected with genetic tests, which look directly for current signs of infection in nasal or throat swabs. Tests to detect antibodies will also be able to identify those who have had infections in the past and may now be immune. In the short term, this will be important because it will permit the authorities to identify who may return to their jobs without risk of infecting others. That is particularly valuable in the cases of doctors, nurses and the numerous other health-care workers needed to look after those who are seriously ill. It will also help in the longer run, by revealing how far the virus has spread through a population, and thus whether or not herd immunity is likely to have built up. Herd immunity is the point where insufficient infectible individuals remain in a population for a virus to be able to find new hosts easily, and it is therefore safe to lift social-distancing and stay-at-home rules.

SARS-CoV-2 antibody tests have already been deployed in limited numbers in China, Singapore and South Korea. Several Western governments, including those of America and Britain, have been buying up millions of surplus antibody tests from China for use in their own countries. Several other types of these tests have also been developed by companies around the world. None, however, has yet been approved for widespread usefor, though such tests are reasonably easy to manufacture, ensuring that they give useful and reliable results is taking a lot of effort.

Each different design of test uses its own recipe of chemicals and processes. Physically, however, many resemble the self-contained plastic sticks employed in the version made by Biopanda Reagents, a British firm. A user first pricks a fingertip. Then he or she introduces a few drops of blood into an opening at one end of the stick. Inside, the blood goes through a series of chemical processes that can identify particular antibodies. It takes around 15 minutes to get a result, and this is displayed in a similar fashion to that used by a typical pregnancy testthe positive identification of an antibody resulting in a coloured line next to its label on the test stick.

There are three interesting signals. A solitary positive for IgM means the person has had a very recent (potentially current) infection. Positives for both IgM and IgG mean the user was infected some time within the past month. A positive for IgG alone means that the infection occurred more than a month ago, and the user should now be immune to a repeat of it. (A negative result probably means no infection, though it could also mean that it is too early in the course of an infection for antibodies to have appeared, since the first IgMs typically turn up only 7-10 days after an infection has begun.)

Before regulators can approve a test for widespread use, they need to validate it. How useful it is can be summarised by two numbers determined during this validation: its sensitivity and its specificity.

A tests sensitivity refers to how good it is at detecting the thing it is meant to detectin this case the IgM and IgG antibodies associated with SARS-CoV-2. A sensitivity of 95% means that, from 100 blood samples known (by other means, such as previous genetic testing) to be infected, the test will reliably tag 95 correctly as having the pertinent antibodies. The remaining five would be identified as having no antibodies presentin other words they would be false negatives.

The other significant number, a tests specificity, measures how good that test is at detecting only the antibodies it is meant to detect. There are seven human coronaviruses and, ideally, a test would detect only antibodies produced in response to SARS-CoV-2. A test with 98% specificity means that, of 100 known uninfected blood samples, 98 will come back (correctly) as negative and the final two will come back (falsely) as positive. Such false positives could have many causes. A common one is cross-reaction, in which a test responds to the wrong antibodies.

To work out a tests sensitivity and specificity, it needs to be checked against hundreds of samples of known status. Given the novelty of SARS-CoV-2, and therefore the lack of easy access to relevant blood samples, this takes time. The British and American authorities are assessing several tests, but have released no validation data as yet, and have been tight-lipped about when they will do so.

An ideal test would be 100% sensitive and 100% specific. In reality, there will always be a trade-off between the two. Make a test acutely sensitive, so that it gives a positive signal with even the tiniest amounts of a relevant antibody present, and it will get less specific. This is because such a fine chemical hair-trigger is likely to be set off by antibodies similar to, but not identical with the target. And vice versa.

This trade-off is not always a bad thing, for it allows different sorts of test to be used in different circumstances. For example, if the intention of testing is to identify doctors and nurses who have antibodies to SARS-CoV-2, so that they can safely return to work with infected patients, because they are themselves now immune to infection, then the most important thing is for a test to have a low rate of false positives. In other words, it needs a high specificity.

By contrast, if the idea is to gather transmission data, sensitivity is the priority. If someone were identified as having had an infection, further tests could trace which of that persons acquaintances were also infected, or had once been infected and were now immune. In these circumstances, a few false positives would not be a disaster. They would probably show up eventually, because those around the allegedly infected individual would not be infected as often as expected. A false negative, though, would mean lost information and a consequent lack of contact-tracing. That would be significant.

Testing of this sort will let doctors understand how a local cluster of infections grows, and therefore what action to take in order to break the chain (meaning, in practice, who needs to be quarantined). This kind of contact-tracing and isolation has been employed to great effect in South Korea through the use of genetic tests for the virus. Antibody tests will enhance the process, by capturing data on those infected in the past as well as the present.

Children are another group who could profitably be monitored using antibody tests. It is now well established that they are less likely than adults to present the symptoms of covid-19, and rarely suffer severe disease. It remains unclear, though, to what degree they are being infected silently, and are thus able to pass the infection on to others around them while apparently remaining healthy themselves. Antibody tests will reveal a fuller picture.

Antibody tests will no doubt also be in demand from members of the public wanting to know their immune statusfor their peace of mind if nothing else. This might be cause for conflict. Even when they are cleared for general use it will take time for manufacturers to ramp up the production of tests, and those working in health care and one or two other important areas, like teaching, policing and delivering groceries to stores and markets, will surely be at the head of the queue to be tested. It is therefore hardly surprising that unvalidated kits, purportedly for domestic use, are already being offered for sale by unscrupulous online suppliers. Britains medical regulator, for one, has had to take down several fraudulent websites and is warning people not to use any home-testing kits they find being sold online.

Even when more kits do become available (and with due acknowledgment to the different putative uses of different sorts of test) the next goal for most countries after protecting crucial members of the workforce will be population-level surveillance. This will, as a by-product, provide information to individual members of the public. But its primary purpose will be to track how the epidemic is progressing.

One of the most important elements of this analysis will be determining the rate of silent infectionwith all the implications that brings for herd immunity. Comparing recent test data from the Netherlands and Iceland hints at the gap in current knowledge of just how much silent infection there may be. Both countries use genetic testing for the virus, but the Netherlands only tests those with severe symptoms of covid-19, whereas Iceland has been testing widely, even people without symptoms. Unsurprisingly, but crucially, the Icelandic approach has revealed far more infections in younger people than the Dutch one (see chart). Moreover, according to Kari Stefansson, who is leading the Icelandic project, 50% of those who have tested positive reported no symptoms.

Mass testing will be laborious. It will mean taking regular blood samples from millions of people, even though the actual analysis will be done by robots in centralised high-throughput laboratories. To save effort, such projects might piggyback on a countrys blood-transfusion services, for donated blood is already subject to rigorous screening for pathogens.

German scientists have announced plans to start, this month, a reasonably large-scale surveillance project. It will monitor blood samples taken regularly from 100,000 participants. Those proving immune may be given a certificate exempting them from restrictions on working or travelling. If nothing else, that would certainly be an incentive to sign up.

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This article appeared in the Science and technology section of the print edition under the headline "Testings testimony"

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An antibody test for the novel coronavirus will soon be available - The Economist

Fulgent Genetics, Inc.s (NASDAQ:FLGT): Fulgent Genetics, Inc., together with its subsidiaries, provides genetic testing services to physicians with clinically actionable diagnostic information. The US$206m market-cap company announced a latest loss of -US$411.0k on 31 December 2019 for its most recent financial year result. As path to profitability is the topic on FLGTs investors mind, Ive decided to gauge market sentiment. In this article, I will touch on the expectations for FLGTs growth and when analysts expect the company to become profitable.

See our latest analysis for Fulgent Genetics

According to the 2 industry analysts covering FLGT, the consensus is breakeven is near. They expect the company to post a final loss in 2020, before turning a profit of US$3.4m in 2021. FLGT is therefore projected to breakeven around a couple of months from now! In order to meet this breakeven date, I calculated the rate at which FLGT must grow year-on-year. It turns out an average annual growth rate of 147% is expected, which is extremely buoyant. If this rate turns out to be too aggressive, FLGT may become profitable much later than analysts predict.

Underlying developments driving FLGTs growth isnt the focus of this broad overview, however, bear in mind that generally a high forecast growth rate is not unusual for a company that is currently undergoing an investment period.

One thing Id like to point out is that FLGT has no debt on its balance sheet, which is quite unusual for a cash-burning loss-making, growth company, which typically has high debt relative to its equity. This means that FLGT has been operating purely on its equity investment and has no debt burden. This aspect reduces the risk around investing in the loss-making company.

This article is not intended to be a comprehensive analysis on FLGT, so if you are interested in understanding the company at a deeper level, take a look at FLGTs company page on Simply Wall St. Ive also put together a list of relevant aspects you should further research:

If you spot an error that warrants correction, please contact the editor at editorial-team@simplywallst.com. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. Simply Wall St has no position in the stocks mentioned.

We aim to bring you long-term focused research analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Thank you for reading.

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When Will Fulgent Genetics, Inc. (NASDAQ:FLGT) Breakeven? - Simply Wall St

ELMWOOD PARK, N.J., April 6, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ: OPK), today announced that it will continue to prioritize COVID-19 testing for hospital inpatients and critically ill patients around the country.

"Our goal is to maintain the current 24 hour turnaround time for these patients," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Nothing is more important than getting a timely result back to the medical personnel on the front lines making treatment decisions on a minute-to-minute basis."

"Multiple types of hospitals, for-profit, not-for-profit, large health systems, individual hospitals, academic medical centers, and community hospitals have all reached out to get their results in a timely fashion. We have now tested almost 200,000 patients and will continue to grow our capacity from 20,000 tests/day to 35,000 tests/day within the next week.While prioritizing hospital patients, at the same time we will continue to strive to keep our current turnaround time for non-hospital patients at 2-3 days from the time we receive the specimen," said Dr. Cohen.

Providers should refer to the most current CDC guidelines for further information on appropriate testing of patients, available here https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html.

About COVID-19 Testing at BioReference Laboratories, Inc.BioReference Laboratories is accepting specimens for COVID-19 testing from healthcare providers, clinics and health systems throughout the United States to promote earlier diagnosis of the coronavirus and to aid in limiting spread of infection. In addition to its nationwide COVID-19 testing offering, BioReference has partnerships with the New York State Department of Health, the New York City Health and Hospital Corporation (NYC Health + Hospitals), the State of New Jersey, the State of Florida and the cities of Detroit and Miami to provide COVID-19 testing.

BioReference is offering a real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay with expected 24-72 hour turnaround time. The Novel Coronavirus COVID-19 test has been made available pursuant to the U.S. Food and Drug Administration Emergency Use Authorization for diagnostic testing in CLIA certified high-complexity laboratories. All tests are conducted in BioReference's main laboratory in Elmwood Park, N.J., which currently has a capacity to run up to 20,000 COVID-19 tests per day. For more information, visithttps://www.bioreference.com/coronavirus.

About BioReference Laboratories, Inc.BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists. For more information, visitwww.bioreference.com.

About OPKO HealthOPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA. In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed. OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial. It's among a new class of GLP-1/glucagon receptor dual agonists. OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad.

Cautionary Statement Regarding Forward-Looking StatementsThis press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's testing for COVID-19 and the timing of and availability of the test, the expected daily capacity for testing, the ability to expand our test capacity and the timeline for doing so, and the expected turnaround time for testing of hospital and non-hospital patients, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by equipment and reagent shortages, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA

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OPKO Health's BioReference Laboratories Partners with Hospitals Nationwide to Provide Prioritized Testing to Inpatients with Suspected Coronavirus...

The answer to South Africas need for a Covid-19 testing kit which is both portable and fast may, in time, lie in the hands of Japans Canon Medical Systems Corporation (CMSC).

Also read: Covid-19: SA not manufacturing rapid test kits Department of Health is looking at a number of options

The company has partnered with Nagasaki University, Japan, to develop the Genelyzer Kit to test for SARS-CoV-2, a testing system which takes under 40 minutes from the time a specimen is collected from a patient to the delivery of results.

In cases where the test has been positive for SARS-CoV-2, it can detect 15 or more viral genome copies with 100 percent sensitivity.

This testing system makes it possible to quickly detect a novel coronavirus gene in patient specimens and, aside from being quick to administer, boasts a light weight, compact design which makes it ideal for a wide range of testing situations, including remote clinical sites.

Also read: Covid-19: WHO announces new recommendations for hand hygiene

The kit, which was validated by the Ministry of Health, Labour and Welfare and the National Institute of Infectious Diseases of Japan on March 26, consists of a set of reagents for SARS-CoV-2 RNA testing using a gene amplification technique known as the fluorescent loop-mediated isothermal amplification (LAMP) method.

Based on the clinical tests, the rapid genetic testing system has been granted approval for practical application in government-conducted testing within Japan.

In order to take full advantage of the testing systems rapid testing capabilities, we will continue evaluating its practical application in public health protection and border control measures at clinical sites, airports, and other locations where testing needs to be completed on the same day.

Canon Medical Systems Corporation hopes that the testing system will be used at a wide range of clinical sites in Japan to help control the spread of Covid-19.

At the same time, our goal is to contribute to the development of effective measures against the spread of infectious diseases in all parts of the world using this rapid genetic testing system, says Canon Medical Systems Corporation president and CEO Toshio Takiguchi.

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Covid-19: The answer to rapid test results may be within reach - Bedfordview & Edenvale News

While testing for the coronavirus has been slow and scarce across the U.S., one Bay Area laboratory has created what they say is a faster, more accurate COVID-19 test, which is already attracting long lines of patients hoping to find out if they are infected.

The virus mutates every day, every week

We were able totweak some parameters and make sure that we give accurate results, but with afaster turnaround time, said Dr. Connie Chao-Shern, a molecularbiologist who helped create the new test with her team at Avellino Labs inMenlo Park. The virus mutates every day, every week, and this [test] actuallyis following the virus in all the mutations.

Dr. Chao-Shern, who serves as the chief lab officer forAvellino Labs, says the new test provides quicker and more accurate results thanother tests, including those created by the CDC.

The quicker wedetect the patients who are positive, the better they we can stop the spread,said Dr. Chao-Shern. The longerwe wait, the more chance of spreading the virus to somebody else.

FDA Authorizes Bay Area Lab to Begin Testing for Coronavirus

After receiving emergency authorization from the FDA, AvellinoLabs received its first batch of tests to process Monday morning. The NBC Bay Area Investigate Unit was theonly media outlet at the headquarters when those initial 33 samples arrived forprocessing.

Avellinos new coronavirus test can be processed within fourto seven hours, which would allow patients to be notified of their resultswithin one day.

Lab Focused on Eye Diseases Pivots to Coronavirus

COVID-19 tests are a new direction for the lab, which, upuntil this week, only focused on making tests to diagnose eye diseases.

We suspended testing of those, said John Hong, who heads the legal department and human resources at Avellino Labs. We've pivoted completely to testing for coronavirus, explaining that because both tests require genetic testing, the technology is similar.

We quickly realized, almost immediately, that this is something that may be able to benefit everyone

The company began developing the COVID-19 test in Januaryafter employees at their Shanghai laboratory complained about a lack of tests inChina. Soon after, Avellino Labs created their own test in California, whichthey then shipped abroad to their coworkers.

We were thinking of that just being a resource internally, Hong said. Then, we quickly realized, almost immediately, that this is something that may be able to benefit everyone.

Firefighters Trade Hoses for Nose Swabs

As the coronavirus began to spread across California, HaywardFire Chief Garrett Contreras began searching for test supplies that his firefightersand paramedics could utilize to care for communities in the Bay Area. Itwasnt long before the Chief connected with executives at Avellino Labs.

One of our vendors...had called me and said that ChiefContreras was looking for the test, said Scott Korney Chief Operating Officerat Avellino. [Contreras] was thrilled that we had availability of testing.

The partnership allowed Hayward to open its first drive-upand walk-up testing site Monday at Hayward Fire Station #7, 28270 HuntwoodAvenue.

Suppression, through isolation after testing, or SIT, as we call it, is an approach that has proven to be most effective in countries on the leading edge of this pandemic, said Chief Garrett Contreras.

His firefighters armed with swabs, thermometers, andtesting kits are now on the front line of the pandemic. In opening the testing site, the department declaredthat sick people, first responders, and health-care workers with recentexposures to the novel coronavirus can be tested for infection.

Coronavirus Tests Remain Scarce

About 60 percent of the coronavirus testing done in the U.S. took place in just about the last week, according to the White House.

"We now have 370,000 tests that have been done," said Dr. Deborah Birx, coordinator of the White House coronavirus task force, who made those comments during a press conference on Tuesday. "The majority of those over 220,000 in the last eight days, which, those of you who have been tracking the South Korea numbers, put us equivalent to what they did in eight weeks that we did in eight days."

Tests, however, remain scarce in the Bay Area and across the country, so only about 10% of those in line at the Hayward site have been tested -- the sick and elderly continue to be prioritized. Yet, to understand the impact of the virus, some argue far more people need to be tested and even retested.

Testing once - it lets you know whether you're infected at that point in time, said John Hong. But without the second test, without the third, fourth test in the future, you can't you can't be assured of anything except for when you got tested that first time.

We will stop this pandemic

Lab employees spent roughly a month, working throughout the night, to develop the test.

It was exhilarating, said Dr. Chao-Shern. We cheered...we, at that time, actually, we hugged!

Currently, the lab can process about 350 tests per day. Over the next two months, however, Avellino plans to triple its staffing in order to increase its processing capacity to 7,000 tests per day.

The number of tests we could actually run will be determined by how quickly we can bring in partners to help us rapidly expand, said Eric Bernabei, Chief Sales and Marketing Officer for Avellino Labs. We have a plan now that we could get close to 200,000 tests per month, he said.

The demand for tests, like the virus, is spreading. Withevery batch of used tests dropped off, new tests are going out. Avellino Labshas been inundated with calls from all over the world, asking if the lab canproduce tests for their communities.

We will prevail, said Dr. Chao-Shern. We will stop the spread and we will stop this pandemic.

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Bay Area Lab Aims to Distribute Millions of Coronavirus Tests After Creating Their Own - NBC Bay Area

Sixteen years ago, in the very early days of medical genetic testing, I received a positive result for one of the BRCA mutations, which are correlated with a vastly increased risk of breast and ovarian cancers. I began interviewing doctors and genetic counsellors, in order to decide whether to have preventive surgeriesand, if so, which ones. I quickly understood that the science of cancer prevention had a tunnel-vision problem: I was counselled to undergo surgeries that would lower my risk of cancer but vastly increase other health risks. I joked that cancer prevention would be the more successful the sooner I died of something else.

What made my predicament more difficult was that the medical advice I got wasnt wrong. Preventive surgeries were the best options available for me to live a longer life. But the advice was dispensed without regard for, or at times even acknowledgment of, the damage that these surgeries would do to my health. I agonized over the risks, the uncertainties, and the irreversible nature of my decisions. In the end, I chose to have the surgeries, albeit not in the order and not nearly on the time frame that was recommended back then. I am now older than my mother or her aunt, who also had the mutation, ever lived to be. But I was profoundly changed by the surgeries. My life now is not fully continuous with my life before the interventions. I like some of the changes and regret the others. I also know that, if I had not been mindful of the unintended consequences of my decisions, my health and my quality of life today would be the worse for it.

In the United States, we are in a similarly terrible predicament now, as a society, as I was as a person with a body. The measures we are taking to save ourselves from a global pandemic of the novel coronavirus are changing us in fundamental, possibly irreparable ways. By instituting lockdowns and deploying a variety of emergency powers across the country, we are destroying our economy, our social fabric, and our political system. We will never be the same. Whether we change for both the better and the worse, as opposed to the solely catastrophic, will depend on how mindful we remain of the damage we are doing as we attempt to save ourselves from the pandemic.

The economy has already taken the biggest sudden hit in memory. Hundreds of thousands of people have lost their jobs, and many more will become unemployed in the coming weeks. Inequalities in wealth, opportunity, and access to health care have become even more glaring than they were just a couple of weeks ago.

The social fabric is being torn in unprecedented ways, owing to school closings, a widespread shift to working from home, social distancing, sheltering in place. Whereas we used to share dozens of experiences a day with friends, acquaintances, and strangersfrom riding the subway to working in an office, standing in line at lunch, going to a concert, eating at a restaurant, chatting to an Uber drivermany of us have been reduced to sharing only isolation and the fear of chance encounters, if either of those can be said to be shared.

Our political system, frayed as it was, is under extraordinary stress. The Supreme Court has delayed cases. The Justice Department is seeking extreme powers. The Trump Administration is using the crisis as an opportunity to push through a more extreme version of its agenda. The President now lies to the nation daily ,not only on Twitter but also on live television, during briefings that he has turned into versions of his rallies. The election campaign is in a state of suspended animation. The borders are effectively closed. At the federal level, there is a real possibility that the coronavirus will paralyze the work of Congress, leaving the White House without check. At the local level, quarantine measures either have stopped or will stop all town councils, school boards, and community meetings. Local news media, an endangered species before the crisis, may have been dealt a final, fatal blow by the coronavirus.

In the past week, several high-profile writers have raised the possibility that emergency measures taken against the pandemic are too drastic. The founding director of the Yale-Griffin Prevention Research Center, David Katz, writing in the Times, has argued that the threat of the pandemic is overestimated. The papers opinion columnist Thomas Friedman echoed this argument. But the problem is that, after the Trump Administration wasted the time that was available to prepare for the pandemics spread, by instituting widespread testing and creating additional hospital facilities, todays Draconian measures are both necessary and probably insufficient. As the President careens toward lifting preventive measures, in order to help the economy at the expense of human lives, we will increasingly find ourselves in the absurd position of demanding that the government drastically curtail all manner of freedom.

The low bar set by the incompetent, self-obsessed, lying President makes any halfway-competent public servant sound brilliant. In New York, Governor Andrew Cuomos popularity seems to have spiked simply because he is acting and speaking rationally. In this time of crisis, with little concrete information available, I need Cuomos measured bullying, Rebecca Fishbein wrote on Jezebel, in a piece called Help, I Think Im in Love with Andrew Cuomo???

We tend to throw the word authoritarian around a lot, usually to mean anything that we perceive as less than democratic. But one of the technical definitions of authoritarianism is a regime in which one person or a single group of people make all governmental decisions, denying the public participation in political life. (This distinguishes authoritarianism from totalitarianism, where people are forced to participate all the time.) When we virtuously retreat to our homes, deserting public space and delegating all authority to one man armed with emergency powers, we are creating a society as close to the textbook definition of authoritarianism as has ever actually existed.

So what do we do now that so much economic, social, and political damage has already been done? We have to start talking about the damage, and thinking about tomorrow. We have to recognize that what we are doing to avoid being killed by a virus is also killing us as a society. We have to make it a priority to restore the social fabric.

One tool that will be necessary for this project is an antibody test, which will tell people whether theyve already had the coronavirus and recovered from it. (Antibody tests for the novel coronavirus exist, but the tests that are currently availableor, for most people, not availableare tests that check for the presence of the virus. People who have already recovered will test negative.) It is currently assumed that people who have recovered from the infection might have immunity to it, at least for a period of time. Provided theyve been quarantined for enough time, these could be the people who can volunteer at hospitals, with food and service delivery, at schools. A large enough number of people with immunity, mobilized intelligently, could not only help prevent new infections but also help remedy some of the inequalities that the crisis has exacerbated.

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In the Midst of the Coronavirus Crisis, We Must Start Envisioning the Future Now - The New Yorker

The story of Britains most successful Covid-19 app yes, there is such a thing started with twins.

Tim Spector, a professor of genetic epidemiology at Kings College London, has been probing and observing identical twins for a long time and in Just 1992 he launched the registry TwinsUK to aid research on the subject. His interest was investigating how people with identical genes could grow up to develop radically different traits and illnesses. Take nutrition: identical twins might eat the same food, but react very differently maybe one will develop an allergy while the other wont; or their blood sugar level would draw dissimilar curves, with different repercussions on each siblings metabolism.

After decades spent researching twins at Kings College, in 2018 Spector teamed up with technologists Jonathan Wolf and George Hadjigeorgiou to launch a startup called ZOE. In partnership with research institutions and universities in various countries, the company started carrying out its own studies about twins and nutrition. Its first study, gauged how over 1,000 people (mostly twins) responded to various kinds of food. A similar study, with a larger sample, is currently underway.

ZOE's business plan was to combine the data gathered through these studies with machine learning, and eventually develop a consumer product able to predict every persons individual response to what they eat. According to a company spokesperson, the product would be like [genetic testing service] 23andme, but for eating.

Then the coronavirus outbreak started. As the virus ripped through the globe, on March 20 Spector resolved to turn to TwinsUKs volunteers to track whether they were showing any coronavirus symptoms, and how those symptoms progressed over time. He roped in ZOE, too which was tasked with creating an app through which twins could report their symptoms. The initial plan was to have all volunteers tested for Covid-19, but the spokesperson says that it has since proved impossible to get hold of the testing kits.

While designing the app, the ZOE team thought that its utility could go well beyond keeping tabs on twins. We realised that this was something that we could make even more useful overall by getting everybody in the public to participate, ZOE president George Hadjigeorgiou says. [This can] help understand how the virus is progressing [in the UK] and also to help understand whether a particular area is at a high risk.

Hadjigeorgiou says the app was developed and inaugurated with a sense of extreme urgency. We just put together a SWAT team and we worked through the weekend to get it live. The result? The Covid Symptom Tracker. The app went live on Tuesday, both for Android and iOS phones. By Wednesday, Britons had downloaded it over a million times.

The app is extremely simple. Users are asked to create an account, and provide information, including age, sex at birth, height, weight, postcode of residence, pre-existing health conditions, and habits such as smoking. Then, theyre asked daily to report any symptom that could be associated with Covid-19. The list currently includes fever, persistent cough, fatigue, shortness of breath, loss of smell or taste, hoarseness, chest pain, abdominal pain, diarrhoea, drowsiness and confusion, and lack of appetite. Hadjigeorgiou says that as more symptoms get flagged by the international research community as potentially relevant to Covid-19 detection, they will be added to the app.

The data gathered this way will be shared with researchers at Kings College and at the Guys and St Thomas' Hospitals, to get a better sense of how the pandemic is spreading through the UK, and which symptoms should be regarded as telltale signs of a novel coronavirus infection as opposed to the common cold or the seasonal flu. Hadjigeorgiou says that the company has also been trying to get in touch with the UK government and the NHS in order to share their data with them, although whether that would result in a partnership was unclear as of Wednesday. The company spokesperson says that ZOE is talking with NHSX, the NHSs digital unit.

According to Hadjigeorgiou, information about how symptoms are being reported in various parts of the UK might be even made public. What we will try to do [Wednesday night] or [Thursday] at the latest is publish the first set of data that we collected, he says. That will be geographical data but whether we'll be able to publish down to the postcode level maybe not yet. But the intent is to share all this information in a way that's useful for people.

Yet, a banner published on the apps website this morning reads: We are not sharing any analysis or data from the app except with researchers at King's College London and the NHS. As soon as they have analysis they are happy with, they will share it. It is unclear whether that will affect the timetable of the publication of the location data.

The company is planning to launch the app in the US in the near future. Hadjigeorgiou says that partner institutions there might include high-profile universities and hospitals with which ZOE which opened a Boston office last year had already been working for its nutrition studies.

The app privacy policy mentions that anonymised data might be shared with US-based organisations including Harvard University, Stanford University, Massachusetts General Hospital, Tufts University, and Berkeley University. The spokesperson also says that the company has been in touch with American hospitals. One paragraph in the apps privacy policy underlines that the data will be handled in accordance with GDPR, but that they might not enjoy similar levels of protection when transferred to countries like the US.

Beyond that, Hadjigeorgiou cannot bring himself to make prediction about Covid Symptom Trackers future. I don't think anybody will know the answer of how the world will look like in two weeks, he says. It would be ideal if this app can be part of the NHSs efforts because that's the only way we can really deliver something that will have everything it needs to be integrated with what public health systems are doing.

As of Thursday morning, the app ranked first on Google Play Store's list of most downloaded health apps in the UK. That is despite the fact that, currently, searching for Covid on Google Play returns no result apart from an app run by the World Health Organisation.

Gian Volpicelli is WIRED's politics editor. He tweets from @Gmvolpi

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The inside story of the UK's biggest coronavirus symptom tracker app - Wired.co.uk

By Michael Le Page

Roberto Pfeil/dpa

Because the symptoms of covid-19 are similar to those of other diseases, testing is the only way to know for sure if someone is infected with the coronavirus. Mass testing is therefore crucial to halting its spread. In the UK, a home test will apparently go on sale very soon.

How do you test for coronavirus infections?

At present, most tests are based on looking for genetic sequences specific to the covid-19 coronavirus. If these sequences are found in a sample, it must contain the virus.

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What does testing involve?

Getting a sample to test involves pushing a swab which resembles an extra-long cotton bud deep inside the nose or to the back of the throat. The swab is then sent off to a lab.

What about testing blood or urine?

The virus is only detected in the blood, urine or faeces of roughly half rof those who test positive based on nose or throat swabs, so blood, urine and stool tests arent reliable. If you are coughing up sputum, testing that can provide more accurate results than a nose or throat swab, according to a handbook summarising findings in China.

How long does it take to get a result?

Most labs use a method called the polymerase chain reaction (PCR), which takes several hours. It can take days for labs to run the tests and tell people their result. Several groups around the world, are developing faster genetic tests, typically based on a method called loop mediated isothermal amplification (LAMP), which takes less than half an hour. Handheld LAMP tests that could be used in homes and airports may start to become available within weeks.

How accurate are the tests?

In theory, genetic tests should be extremely accurate if done properly. However, there have been reports from China of many false negatives and false positives. This may be because the swabbing wasnt done correctly, or because overworked lab technicians were making mistakes. In addition, if people are tested very soon after becoming infected, they may not be shedding the virus yet.

Why is it so hard to get tested in most countries?

There are obvious practical issues with scaling up testing, from lack of trained personnel to equipment. But South Korea, which is now testing more than 20,000 people per day, has shown how fast it can be done. Many other countries didnt start ramping up testing capacity until local case numbers began to soar and unlike South Korea havent made testing central to their strategy as advised by the World Health Organization.

I have heard some tests can be done in 10 or 15 minutes. How do they work?

Rapid tests, such as the one that may roll out in the UK soon, are usually based on detecting proteins rather than genetic sequences. These proteins can either be viral ones, called antigens, or the antibodies our bodies make to kill the virus. Antigen tests can directly detect the presence of the virus, but are less accurate than genetic tests.

What about antibody tests?

The downside of antibody tests is that they cannot detect infections in the first two weeks or so, when people are most contagious. However, our bodies keep making antibodies even after we have recovered from an infection, so testing peoples blood for antibodies against the coronavirus will reveal how many of us have been infected so far. This will help us calculate the infection fatality rate.

Can antibody tests distinguish between people who have recovered and those who are still infected?

Sometimes. People start producing so-called IgM antibodies against the coronavirus around 10 days after showing symptoms (perhaps 15 days after infection). After another two days, their bodies start making IgG antibodies, and gradually stop making IgM. Most people will recover fully as soon as IgG levels ramp up. Many rapid tests can detect both types of antibodies. If IgM antibodies are present in someones blood, they are likely to be still infected. If only IgG is present, they are recovering or fully recovered.

How accurate are these rapid tests?

We dont know. Numerous companies are producing different tests that havent been independently checked yet. In general, testing for antigens or antibodies is less accurate than genetic testing, but the tests are easier and cheaper to manufacture. Rapid tests could play a valuable role, especially in poorer countries with little testing capacity. If they can reliably tell us when people have already been infected, it would allow key workers especially in healthcare to continue working without worrying about becoming infected or infecting their families.

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How does coronavirus testing work and will we have a home test soon? - New Scientist News

Detailed knowledge of the human genome can provide us with extensive information about the causes of disease and how patients will respond to treatments. In this article, Pushpanathan Muthuirulan explores the concept of genetic testing and the potential for pharmacogenomic testing to transform healthcare.

Genomic assays offer enormous potential for improving human health. Recent advances in high-throughput genomic assay technologies have enabled development of more rapid and accurate genetic testing methods that can survey the entire human genome and pinpoint the genetic defects associated with diseases. Genomic assays offer deeper insights into disease causation in families and have improved our ability to diagnose and treat genetic disorders by targeting specific genetic subsets. The rapid pace of the discovery of genetic changes associated with disease has enabled researchers to predict the risk of genetic disorders in asymptomatic individuals, offering tremendous potential for unlocking value in precision medicine. Thus, genomic assays are on the cutting edge of medical innovation, offering resources to clinicians and healthcare providers for patient care and driving the future of medicine.

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Genomic assays: on the brink of revolutionising human healthcare - Drug Target Review

Ever since the Human Genome Project began in the late 1980s, genetics and DNA have become topics of mass interest. The book Genome: The Autobiography of a Species in 23 chapters states that the genome is a book that wrote itself, continually adding, deleting, and amending for over four billion years.

For Dr Surendra Chikara, who has been working in the field for over 20 years now, the idea of founding Bione, a healthcare startup, was a no-brainer.

Monitoring the present coronavirus outbreak scenario in the country, we have included new parameters to our Longevity Plus kit. The new updated kit provides information about the susceptibility of a person to viruses like coronavirus, SARS-like viruses, HIV, Hepatitis C virus, etc. This could be based on an individuals genetic makeup or the patterns of living, Surendra says.

Dr Surendra, Founder of Bione

Surendra says a recent addition to the Bione Genetic test can check an individuals susceptibility to coronavirus. He adds that the platforms microbiome test, combined with its predictive analytics tools and artificial intelligence, can provide tailored recommendations to individuals to strengthen their microbiome and improve their immunity.

A research paper titled 'Evidence of gastrointestinal infection of SARS-CoV-2 revealed that 23.29 percent patients infected with SARS CoV-2 showed positive results in stool after showing negative in respiratory samples. Hence, the gut microbiome test is the only way to know when a virus is no longer in your system, Surendra says.

Surendra started his career with recombinant DNA technology and worked with Dr Gita Sharma, who had created the first r-DNA vaccine for Hepatitis-B in India.

My journey in genomics started under her support and guidance. It was the time when human genome sequencing and next-generation sequencing were starting to gain importance. We were in discussions to bring D2C technology to India, but the Indian healthcare market was not ready for direct-to-consumer genetic testing," Surendra says.

This is a huge problem that all my networks were aware of. We all know that the future of the global pharmaceutical industry lies in developing precision medicines tailored for individuals based on their genes, and clinical risk for developing a disease. Indian genetic data is highly diverse and a number of breakthroughs can happen. At Bione, we are doing our part to be part of this bigger picture of making India disease-free, Surendra says.

The different types of kits depend on the number of tests covered, and include Longevity kit, Longevity Plus Kit, and MyMicrobiome kit. The Longevity Plus kit covers over 415 parameters, including health, personalised medicine, fitness, and wellness.

The team claims that it also covers a parameter that determines specific gene variants that may contribute to enhance resistance to viruses like coronavirus, HIV, Hepatitis C, and many others.

The MyMicrobiome kit identifies and quantifies the microbiome in the gut, based on which a personalised diet is recommended.

Surendra says scientific research has shown that the gut microbiome plays an important role in the function and maintenance of our immune system. In ideal conditions, this microbiome-immune system alliance allows the initiation of protective responses against germs.

The platform also offers sample collection, with samples collected from an individuals homes. A pick-up is arranged as per your convenience by Bione. The DNA sequencing is done in a well-equipped lab by expert scientists, after which a detailed report is prepared.

Bione gXplore is a user-friendly, informative, and interactive app-based platform. On it, you can go through your report and easily understand the results of DNA analysis.

Slots with genetic or food and nutrition counsellors are provided as a free-of-cost service. The expert team of counsellors guides you to proactively plan your and your familys health and lifestyle choices.

The Bione team consists of experts from global institutions and scientists domains of genomics, genetics, bio-IT, genome informatics, quality assurance, sales, marketing, genetic/nutrition/fitness counselling. The startup has a total team size of 39 people.

The startup also runs a lab with scientists, bioinformaticians, and genetic counsellors. The team is applying for ISO 9001:2015, followed by CAP and CLIA accreditation to follow global standards.

Bione is projecting to test 20,000 to 30,000 samples in the first year of operations. Tests are priced between Rs 5,000 to Rs 20,000, with the option of paying in EMIs. Customers can choose the package based on their needs.

The startup has raised angel funding from a clutch of undisclosed investors. Gourish Singla, the Founder of blockchain startup Project Shivom has invested in Bione.

Currently, startups like The Gene Box and Hyderabad-based MapMyGenome work on providing preventive solutions based on an individuals genetic makeup.

He says the startup's high tech lab is using advanced technologies, including whole genome sequencing, while the competition is still working with array technology with limited markers.

(Edited by Kanishk Singh)

How has the coronavirus outbreak disrupted your life? and how are you dealing with it? Write to us or send us a video with subject line 'Coronavirus Disruption' to editorial@yourstory.com

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How healthtech startup Bione aims to use genetic testing in the fight against coronavirus - YourStory

GRAND RAPIDS, Mich., March 23, 2020 /PRNewswire/ --To combat the lack of availability of tests, NxGen MDx announces the immediate launch and availability of their COVID-19 test.

The rise in U.S. cases of COVID-19, a highly contagious and sometimes fatal respiratory illness, has concerned health officials and spurred calls from lawmakers for action to expand testing capacity to slow its spread.

"Like the CDC-built kits, ours will be conductedon QuantStudio qPCR instrumentation and will be able to process 2000 samples per day with tests being resulted in 24-48 hours," said Dr. Jacqueline Peacock, Director of Laboratory Operations.

The test will help meet a major U.S. shortfall of diagnostic capabilities that has severely limited the nation's ability to track the spread of the outbreak.

"COVID-19 is a global challenge and we are committed to providing people on the frontlines of this pandemic with critical tests to help ensure proper care," said Alan Mack, CEO of NxGen MDx.

To ensure providers can give their patients the most comprehensive diagnostic results, NxGen MDx is also working to validate a 40+ respiratory pathogen panel to identify the cause of respiratory symptoms in a single test. This test is slated for launch in July 2020.

About NxGen MDxNxGen MDx LLC is a leading women's health company delivering highly accurate and precise genetic testing. NxGen MDx's history of whole-gene sequencing combined with advanced technology allows us to provide accessible, high-quality testing options to families as they plan for the future. NxGen MDx employs state-of-the-art technology, including rapid molecular diagnostics for infectious disease and genetic screening technology that examines the entire gene rather than parts of the gene, giving women and families a comprehensive assessment of their health. NxGen MDx is based in Grand Rapids, Michigan. To learn more, visit the company's website at http://www.nxgenmdx.com.

Connect with us on:Facebook - https://www.facebook.com/nxgenmdx/LinkedIn - https://www.linkedin.com/company/3832246Instagram - https://www.instagram.com/nxgenmdxlab/Twitter - https://twitter.com/nxgenmdx

View original content:http://www.prnewswire.com/news-releases/nxgen-mdx-announces-the-immediate-launch-and-availability-of-their-covid-19-test-301028394.html

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NxGen MDx announces the immediate launch and availability of their COVID-19 Test. - P&T Community

With a simple sample of your saliva or swab of your cheek, a DNA testing kit can be used to research your familial origin or ancestry and determine paternity. Formerly a niche pursuit, home DNA testing is now an easy way to map out your family tree.

The kits have become quite affordable over the past few years, too, with a wide range of DNA testing companies -- from trailblazers such asAncestryand23andMeto upstarts such as LivingDNA-- selling testing kits.

You can learn a lot from DNA testing. In addition to deepening your understanding of ancestry, some services will introduce you to living relatives around the world through a common ancestor or use markers to shed light on your predisposition to specific health issues and diseases. Others will even test dog DNA and give you insight into your dog's health and breed makeup. Here we present to you our roundup of the nine best DNA test kits and services -- what they offer, how they work and how much they cost.

We'll update this story as we continue our in-depth testing of these services. In the meantime, the ones included here are the most popular DNA testing services as determined by Google keyword search rankings.

Looking for more in-depth info on DNA testing services in general? Jump to our explainer.

Named for the 23 chromosomes found in human cells, 23andMe offers a battery of tests, including some that analyze health risks like Type 2 diabetes and Alzheimer's disease. (It was these tests thatattracted attention from the FDA.)

23andMe earns points for the depth of its medical tests, as well as the size of its match database. Purchasers of this DNA kit should note that the basic DNA test is $99 but that medical results cost another $99.

The added expense may be worth the money; the additional information includes genetic health risk information, wellness reports, trait reports, and carrier status reports, which indicate whether a particular DNA profile may be a genetic carrier of a disease or disability.

Your DNA information is gathered using a saliva sample from Autosomal DNA testing, which, once analyzed, is stored forever on 23andMe's servers. The service also provides for a chromosome browser and comparison, as long as any possible matches approve your access. The service's matrilineal and patrilineal line testing can geolocate your ancestry DNA in more than 1,000 regions.

(Appropriate for a genomics company, 23andMe's executive ranks contain some interesting familial relationships: CEO and co-founder Anne Wojcicki is the former wife of Google co-founder Sergey Brin and sister of YouTube CEO Susan Wojcicki.)

Ancestry DNA has a vibrant genealogical community and offers a wide range of databases, research resources and family matching features. The Ancestry DNA test provides analysis segments of your DNA results and traces its origins to 500 geographic regions throughout Europe, Africa and Asia -- the most detailed of any of the services we've profiled. AncestryDNA also says that it can help you learn about up to 26 traits and attributes you've inherited from your ancestors -- all from a little bit of saliva.

Ancestry maintains a free family tree search tool, and you can add your specific results to that database. You can also download your full DNA profile and import that data into another tool -- but Ancestry doesn't offer a chromosome browser, so you can't do DNA segment comparisons. Ancestry DNA stores results in its DNA database forever.

FamilyTreeDNA is operated by Houston-based genetic testing lab Gene-by-Gene. Gene-by-Gene also operates the Genomics Research Center for National Geographics' Genographic Project, which has concluded its public participation phase.

FamilyTreeDNA offers a wide range of tests. The basic autosomal test costs $79 (plus shipping) and is conducted with a swab test sample of your cheek cells. You can add sequences and markers, and your father's line and mother's line tests, but that will step up the price considerably.

If you're interested in doing in-depth analysis, the FamilyTreeDNA offers a chromosome browser, allows raw data to be uploaded, provides support for setting different segment matching thresholds and allows up to five comparisons to be done at once. FamilyTreeDNA allows trial transfers from 23andMe and Ancestry DNA into its DNA match database; additional transfers of various datasets are available for a fee. FamilyTreeDNA promises to keep data for 25 years.

Offering DNA test kits and a range of online subscription services, MyHeritage says that its database includes more ethnicities -- that's 42 -- than any other major testing service. The free 14-day trial will let you poke around the company's massive online DNA database which includes 3.5 billion profiles in addition to information about over 100 million subscribers and their collective 46 million family trees.

Starting at $79, the company's DNA testing kits are competitively priced and cover the basics: A simple cheek swab will give you an analysis of your ethnic origins and the identification of relatives who share your DNA. In addition to MyHeritage's free basic subscription, which will let you assemble a family tree up to 250 people, there are other packages that accommodate larger trees, advanced DNA features, and more robust research tools. The company allows you to upload test data from other DNA testing services.

MyHeritage says that it has also sold more than one million DNA testing kits -- but its enormous database is largely powered by Geni.com, a genealogy social mediaaccording to the New York Times site, that has assembled "the world's largest, scientifically vetted family tree," according to the New York Times. (MyHeritage is Geni.com's parent company.)

HomeDNA is kind of like the Walmart of DNA testing, which is somewhat appropriate given that the company's testing kits are sold at Walmart stores in addition to CVS, Rite Aid and Walgreens pharmacies.

HomeDNA offers a range of DNA ancestry testing services priced between $69 to $199. Though the jury is still out about the effectiveness of specialty tests, HomeDNA also sells test kits to determine food and pet sensitivity ($99), diet and exercise strategies based on your genetic makeup ($119), paternity ($164), and even skin care ($99).

Dog owners can buy a dog DNA test to help you determine your dog's breed history for $125. You can also buy a $125 health screening for your dog or cat that includes a series of tests for genetic diseases and traits. (If you're interested in a canine DNA test for less, Wisdom Health offers a dog DNA test kit for under $80.)

Testing is done with a mouth swab. Shipping is free. And results are kept for 25 years.

African Ancestry can't compete on price or the size of its match database, but it does offer deep regional analysis. It's a worthy specialized service for individuals looking at exploring African ancestry.

Rather than a match database of individuals, African Ancestry has the world's largest database of African lineages. The company can trace your ancestry back to a region in Africa and then pinpoint its location today. It can also dive deep into history and help find original ethnic groups that may date back as long as 500 years ago.

But the tests can get quite expensive. The company sells a maternal test kit and a paternal test kit for $299 each (shipping is free). If you want to trace both your maternal and paternal lines back through this DNA database, it'll cost you about $600. Still, for African family histories, the depth of analysis is unique among the services we profiled.

The Full Genomes service is so expensive, it offers a payment plan. But the service offers the largest library of Y-chromosome SNPs around. So if you want to explore your patrilineal background, this is the most comprehensive option on the market. You can also look into your mitochondrial DNA. There's no family match database, however.

Testing is done with a cheek swab. The company charges $25 for shipping.

Living DNA is a UK-based genomics firm that offers autosomal DNA data, as well as a breakdown of matrilineal and patrilineal lines. DNA data is gathered through a mouth swab.

Living DNA has a very limited family match database, so if you're looking for a service that can match you to relatives around the world, this isn't the one for you. But Living DNA's test is quite comprehensive, analyzing multiple types of DNA: it tests 638,000 autosomal SNPs, 22,500 Y chromosome SNPs and 17,800 X chromosome SNPs, along with 4,700 mitochondrial SNPs.

And the service tracks DNA to 150 geographic regions. Those with a UK family history will see a map of where paternal and maternal ancestors lived on the islands. Though we didn't test it first hand, Living DNA says its tools allow you to upload DNA data from other services to predict relationship matches.

Nebula Genomics offers a somewhat different take on DNA testing from the other testing services we've profiled. While you can order a full test kit from the company (and you should check to see if they're running a price promotion before ordering), you can also upload an existing DNA sequence from Ancestry or 23andMe's DNA database and get Nebula's reports at a reduced price.

The company claims a very different approach to DNA testing. Where most DNA testing firms examine a subset of the DNA sequence, Nebula says it examines the whole DNA sequence. They tell us they test, "1.3 billion positions and results in one thousand times more data than tests that use microarray-based genotyping.".

While the company does not offer a family-finding match database to connect you with relatives, they do offer a unique art print based on your DNA. We're not entirely sure we'd want to showcase our DNA up on the wall along with our prints of dogs playing poker and velvet Elvis, but Nebula's prints are quite attractive.

Of more note is the depth of the company's scientific reports based on your DNA sequence. The company also tests the microbiome in your mouth, providing a detailed overview of the bacteria contained inside your mouth and what it means for your overall health.

We wouldn't necessarily recommend Nebula's kit as your first stop on your DNA testing journey, particularly if you want to connect with your ancestors and family tree. But if you want to dive deeper even than 23andMe into the medical aspects of both your DNA and your personal mouth biome, Nebula is definitely a fascinating option to explore.

If you're using a home DNA testing service, you're likely looking for one of three things:

Ancestry and family history:The first big draw of a full DNA test is that you'll get a detailed breakdown on ancestry and ethnicity, and the migration patterns of your common ancestors. Spoiler alert: Your ethnic background may be radically different than you think it is. You'll also find out what a haplogroup is.

Relative identification:With your permission, some DNA services will let you connect with relatives you never knew you had -- other folks with matching DNA who have used the service and likewise given their permission to connect to possible relations.

Health and disease info:DNA testing can also indicate which conditions for what you may have a preponderance. It's a controversial feature, to be sure. Knowing that you have a genetic predisposition to a certain form of cancer may make you more vigilant for testing, but it may also lead to increased stress -- worrying about a potential health condition that may never develop, even if you're "genetically susceptible" to it. The possibility of false positives and false negatives abound -- any such information should be discussed with your doctor before you act upon it.

Afraid of needles and drawing blood? That's not an issue with these kits, which all involve either a swab test or a little bit of spit. All you need to do is spit into a vial or rub a swab in your mouth -- all the genetic data needed for these tests is present in your saliva -- and ship the DNA sample to the company for analysis.

The reason that a saliva sample works as well as blood (or hair follicles or skin samples) is that your DNA -- which is short for deoxyribonucleic acid -- is present in all of them. It's the basic genetic code present in all of your cells that makes up your key attributes, from the color of your eyes to the shape of your ears to how susceptible you are to cholesterol.

The key terms you need to know when comparing DNA testing services are:

SNP (single nucleotide polymorphism):Genotyping is done by measuring genetic variation. One of the more common is SNP genotyping, which measures the variations of a single nucleotide polymorphism. In our service summaries below, we discuss the number of SNPs. That's because the more a company measures, the more granular the variations analyzed.

Autosomal DNA testing:An autosomal test can be administered to both men and women and traces lineage back through both the maternal and paternal bloodlines.

Y-DNA:The Y-DNA test can only be administered to men and traces DNA back through the patrilineal ancestry (basically from father to grandfather to great grandfather).

mtDNA:The mtDNA is matrilineal and lets you trace your ancestry back through your mother, grandmother and great grandmother.

Autosomal tests can get you quality genetic information going back about four or five generations. Because the Y-DNA and mtDNA tests are more focused on one side of the line, you can get information going back farther, but with fewer data about family structure.

Before you use any of the services we've highlighted below, keep these important factors in mind.

Match database size:If you're looking for living relatives and not just curious about your origins, this is important. Simply put, the bigger the pool of available data, the better the chance you'll have of finding a match.

Privacy concerns:Nothing is more private than your health data, which is why you should make sure a prospective DNA testing site doesn't just keep at-home DNA test results security, but also follows the same best-practice online security protocols you'd expect from your bank or email provider. You'll want to look for two-factor authentication, an encrypted password database and so on.

But for DNA companies/testing providers, you should also investigate how they're sharing your genetic data -- even if anonymously -- and how long they keep the data. It's not just academic: Authoritiesrecently identified a suspect in the Golden State Killer murdersthanks to an open-source DNA and genealogy service known as GEDmatch (not profiled here).

If you're creeped out by how much information Facebook,Googleand Amazon have on you based on your online browsing habits, just remember that these DNA testing services are getting what is effectively your medical history -- especially those DNA analysis services that detail genetic health risks like Alzheimer's disease and Parkinson's disease. Make sure of their policies before turning over that valuable data. Also, even if you don't share your DNA with a service, your familial DNA data may be available if a relative shared their genetic material. The privacy issues can get very complex.

Don't expect perfect accuracy.Testing kits can give you indications, but taking a DNA test with one of these testing services won't magically produce a history book of your family's background.

Consult a doctor on any health data:Cancer. Leukemia. Heart disease. Alzheimer's disease. There are a lot of scary afflictions out there, and your DNA testing may well indicate which ones to which you are genetically predispositioned. But the data markers from DNA testing kits exist in isolation. You should consult your doctor to explore the data from any of these tests. They'll help you determine how to implement any lifestyle changes or followup testing as a result, if it's worth doing so.

CNET's Justin Jaffe contributed to this story.

Updated periodically with new information.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

See the original post here:
Best DNA testing kit in 2020: 23andMe, AncestryDNA and more compared - CNET

Monday, March 23, 2020 3:30 p.m. CDT by Todd Epp

SIOUX FALLS, S.D. (KELO.com) -- Sioux Falls two health care giants--Avera Health and Sanford Health--have been approved to test for COVID-19.

First, the release from Sanford:

SIOUX FALLS, S.D. Sanford Health has launched a test for the COVID-19 virus using an FDA-approved method under Emergency Use Authorization.

Tests will be available at Sanford clinics and medical centers, and processed at the Sanford laboratory in Sioux Falls. Patients will receive results in 24-48 hours.To be tested, patients must meet high-risk criteria and have a physician order.

The new Sanford testing capability will enable far more patients to be tested with faster turnaround time.

Sanford estimates it will be able to process nearly 400 tests per day, with plans to double that capacity in the coming weeks.The expanded testing will also provide public health officials more data about the spread of COVID-19 in the communities Sanford serves.

This was a tremendous effort on the part of our team to rapidly validate and launch our own internal testing, said Dr. Allison Suttle, chief medical officer for Sanford Health. Our testing will deliver faster results, enabling us to provide responsive care and keep our patients and staff safe.

Previously, tests were sent to the state Department of Health or commercial laboratories. Sanford will continue to use these external labs as needed for any overflow testing.

Sanford Healths test is FDA compliant and test results have been validated over the last week.

To get a test, Sanford patients must meet criteria defined by the Centers for Disease Control, including:

If patients are experiencing symptoms, they should call their provider instead of going directly to their clinic.

Sanford is also offering e-visits for COVID-19 care in Minnesota, North Dakota and South Dakota. Ane-visitis an online questionnaire about symptoms that patients complete from home. A Sanford provider will review and respond within four hours with a treatment plan or prescription, or instruction to be seen in-person for further evaluation or testing.

Next, Avera:

Averas laboratory in Sioux Falls has been verified by the South Dakota Department of Health to perform COVID-19 testing.

The Avera Institute for Human Genetics has worked closely with the governors office as well as the state health department to establish guidelines on how pending tests are processed. This additional testing site will allow processing of up to 200 tests per day. Avera will have the ability to enter these results directly into the patients AveraChart electronic medical record.

The most critical and highly suspicious tests will receive priority. Result time will depend on volume, however, most test results will be able to be returned in a few days and inpatient tests that are considered urgent based on the patients condition can be returned more quickly.

To date, this testing has been conducted by the state health departments laboratory and Averas contract laboratory.

We are incredibly proud of the teamwork that was involved in making this happen so quickly. This will benefit our patients, health care workers and the general public. The health and safety of our patients and communities are the utmost important to Avera. We hope the addition of more testing sites will expedite results and calm worries, said Bruce Prouse, MD, Clinical Vice President of the Avera Laboratory Service Line.

Testing of COVID-19 samples is a complex process. Thanks to Averas background with genetic testing, we have the expertise and equipment to accomplish this, Prouse said. Getting this validation completed so quickly took amazing teamwork by our laboratory staff as well as state health officials. All are working together in the best interest of patients and the greater population.

All test results will be sent to the state for reporting purposes. Patients with positive test results will be contacted with instructions on how to care for themselves at home, symptom management, and when to contact health care provider if symptoms worsen.

Learn more at Avera.org/COVID-19

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Both Sanford and Avera approved for COVID-19 testing - KELO AM-FM

Nevada State Public Health Laboratory Director Dr. Mark Pandori shows us how they test samples for COVID-19. Reno Gazette Journal

Northern Nevada is only at the very beginning of the worlds coronavirus pandemic, said President and CEO of Renown Health Tony Slonim.

We would expect things to get worse before they get better, said Slonim in an interview Friday with the Reno Gazette Journal.

Slonim, who has been at the helm of Renown since 2014, talked candidly about the shortcomings of the medical system in Nevada, where testing for COVID-19 is still low, and how he navigates a system in a state where finding enough doctors has always been a struggle.

I think the important part for me, when you are in one of these crisis moments, you train for it, you drill for it, prepare for it for years as your responsibility, and the day actually comes when you have to use your skills," Slonim said. "It's a little bit ... its humbling."

Study: Reno among metros most vulnerable to a COVID-19 recession; Las Vegas in top 5

Theres been nothing like this crisis before for Slonim, who has an impressive resume.

He was at Childrens National Medical Center in Washington, D.C., on 9/11, working in the trauma center and intensive care unit of a pediatric hospital.

This reminds me of that, he said.

Slonim is quick to praise his medical team and others in the statewho have come together in this crisis.

He is on daily calls with leaders of other hospitals. They talk about the supply of ventilators.As he watches what has happened in other cities as the virus has spread, he knows there arenot enough.

Dr. Tony Slonim(Photo: Jamie Kingham, provided by Renown)

At some point there was a tipping point where the volume of patients increased dramatically and that outstripped the capabilities both supply wise, experience wise and equipment wise, he said.

Slonim said there are a couple of hundred ventilators available in Northern Nevada. He and the other hospital executives talk about how to get more.

But its not just ventilators.

You cant just have a ventilator. You have to know how to operate it, he said.

Despite Nevada focusing on recruiting doctors to the Silver State, there is still a shortage that is decades-old problem.

"We are short. We start needing people. You have to give people a break in this, he said, adding that in this type of crisis, staff will befatigued.

Coronavirus updates: Clark reports 52 new cases, Washoe reports 4 includes UNR student

It takes extra effort to provide care in an isolation environment.

The staff he has could be stretched thin, something he watchesknowing he must rotate people in charge and staff who often wantto keep working.

He calls staff his heroes,from doctors and nurses to people looking for supplies. Many have given up vacations and put aside their own worries to work.

Unfortunately, events like this bring out the best in people, he said.

Slonim sounds almost careful when asked about the number of test kits and how testing is going in Nevada. He said the governor and the health department are diligently working and aware of the problems.

A triage tent is seen at Renown Regional Medical Center in Reno on March 12, 2020.(Photo: Jason bean)

He said they are doing the best with the tests they have.

To date, Nevadahas tested nearly 2,100 people and as of Friday positive cases were nearing 200. Two people in Clark County have died.

But Slonim said Nevada needs to test more.

We need broader capabilities around making sure we have broad-scale surge testing available in Nevada, so we can segregate people who have it from those that do not, he said.

He said the same type of testing the state pioneered with the Healthy Nevada Projectshould be happening for COVID-19.

Launched in 2016, the Healthy Nevada Project was a community-based population study where genetic testing was provided to thousands of Nevadans to learn about the health of the community and genetic risks.

Coronavirus in Nevada: Cannabis sales, deliveries increase as Nevadans stock up on pot amid COVID-19 isolation

Because if I could test 60,000 people in Northern Nevada (for COVID-19), I would really understand with data and factsthe proportion of people who actually have it versus those that just have the sniffles and a cold.

He said it would help him and others make decisions and plan for coronavirus with evidence. He wants to be able to test nursing home patients.

We know, boy do we know, that nursing home residents are vulnerable, he saidof knowing they will eventually get sick and come to the hospital, triggering an influx of patients.

Testing is pivotal upstream, so you can prevent consequences downstream.

The triage tent is seen at the Renown Regional Medical Center in Reno on March 12, 2020.(Photo: JASON BEAN/RGJ)

Slonim admits hes anxious. He worries about his family and his elderly parents who live outside of a coronavirus epicenter in New York.

And there are days even he wonders if he is getting sick.

All of the sudden you are convinced you have COVID-19, he said. You can make yourself feel something if you let your imagination run wild.

Wondering with every coughif you've come down with the virus isn't limited to laypeople:Its real. It happens to me. It happens to my family."

He says the hospital feels like it does on the streets.

There is an air of what is going on, he said.

Elective surgeries were put off. More than 2,000employees who can work from home do. And many employees are waiting for the surge that will come.

Not to minimize it by these words, but it is our responsibility to go on as businesses as usual.

Siobhan McAndrew tells stories about the people of Northern Nevada and covers education in Washoe County. Read her journalism right here. Consider supporting her work by subscribing to the Reno Gazette Journal.

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ELMWOOD PARK, N.J., March 24, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ: OPK), today announced a collaboration with the City of Miami to provide coronavirus disease 2019 (COVID-19) testing. BioReference will provide COVID-19 testing at drive-through locations for Miami residents by appointment.

BioReference is also announcing that they are providing testing for drive-through testing centers in South Florida, Hialeah and Hollywood through a collaboration with Larkin Community Hospital.

"We all are responsible for helping to control the spread of this virus," said Francis Suarez, Mayor of the City of Miami. "As an individual who tested positive for COVID-19, I have a duty to the City of Miami to bring my city's residents access to testing and information, and through our partnership with BioReference, we can help address this public health crisis."

"BioReference continues to prioritize expanding public access to COVID-19 testing across the nation," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "The importance of high-quality, reliable, scalable laboratory tests available is a critical part of the response in the effort to contain COVID-19."

If you demonstrate symptoms related with COVID-19, please call the Florida Department of Health immediately: 1-866-779-6121 or call the City of Miami COVID-19 Center: 1-305-960-5027.

Providers should refer to the most current CDC guidelines for further information on appropriate testing of patients, available here https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html.

About COVID-19 Testing at BioReference Laboratories, Inc.BioReference Laboratories is accepting specimens for COVID-19 testing from healthcare providers, clinics and health systems throughout the United States to promote earlier diagnosis of the coronavirus and to aid in limiting spread of infection. In addition to its nationwide COVID-19 testing offering, BioReference has partnerships with the New York State Department of Health, the New York City Health and Hospital Corporation (NYC Health + Hospitals), the State of New Jersey and the City of Detroit to provide COVID-19 testing.

BioReference is offering a real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay with expected 24-48 hour turnaround time. The Novel Coronavirus COVID-19 test has been made available pursuant to the U.S. Food and Drug Administration Emergency Use Authorization for diagnostic testing in CLIA certified high-complexity laboratories. All tests are conducted in BioReference's main laboratory in Elmwood Park, N.J., which currently has a capacity to run up to 15,000 COVID-19 tests per day. For more information, visit https://www.bioreference.com/coronavirus.

About BioReference Laboratories, Inc.BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists. For more information, visit http://www.bioreference.com.

About OPKO HealthOPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA. In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed. OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial. It's among a new class of GLP-1/glucagon receptor dual agonists. OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad.

Cautionary Statement Regarding Forward-Looking StatementsThis press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's plans to begin testing for COVID-19 in Miami and the timing of and availability of the test, the turn-around time for testing and test capacity, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by general market factors, reagent and supply shortages, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA

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OPKO Health's BioReference Laboratories and City of Miami Provide Testing for Coronavirus Disease 2019 (COVID-19) - GuruFocus.com

The Asia Pacific prenatal and newborn genetic testing market is expected to reach US$ 1,679.956 Mn in 2027 from US$ 630.914 in 2018. The market is estimated to grow with a CAGR of 11.6% from 2019-2027.

The key factors responsible for the growth of the market in Asia Pacific are rising burden of genetic diseases among infants, increasing fertility rates and developing healthcare scenario with rising awareness among populace regarding the benefits of prenatal testing. On the other hand, use of digital microfluidics in newborn testing is likely to be a prevalent trend in the future years. Soaring birth rates among developing economies are responsible for fueling global baby boom. However, the rising birth rate also contributes to rising birth defects and infants suffering from several genetic diseases. According to a report published by Bill and Melinda Gates Foundation in 2018, there are almost 250 babies born every minute around the globe. Moreover, according to the Centers for Disease Control and Prevention, the fertility rates for Hispanic women was highest in 2017 among Hispanic women with 67.1 births per 1,000 women.

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Some of the major primary and secondary sources for prenatal and newborn genetic testing included in the report areFood & Drug Administration (FDA), Indian Institutes of Technology (IITs), International Trade Administration (ITA), Japan Society of Obstetrics and Gynecology (JSOG), Council of Scientific and Industrial Research (cSIR), Pakistan Down Syndrome Association (PDSA) and others.

Asian countries such as India and China also have high fertility rates due to factors such as effects of religion, inadequate supply of family welfare services, poverty, and others. According to the World Bank in 2016, the fertility rates in India were reported to be 2.23 births per women as compared to 1.80 in the United States and 1.62 in China. Moreover, neighboring countries, such as Pakistan also have alarming rates of fertility. In 2016, the birth rate in Pakistan was reported to be 3.48 births per woman as per the World Bank data. However, the birthrate in India has successfully reduced its high fertility rate, but still is high as compared to other developed nations. According to the United Nations (UN) report published on June 2019, the fertility rate has reduced to 2.1. Therefore, by 2050 additional 273 million people will be added to Indias population. The increasing number of parturient women across the world are thus likely to create increasing demand for prenatal and newborn genetic tests across the globe leading to the growth of the market.

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The Asia Pacific prenatal and newborn genetic testing market, based on the disease indication was segmented into cystic fibrosis, sickle cell anemia, downs syndrome, phenylketonuria, recurrent pregnancy loss, and Antiphospholipid syndrome, and other diseases. In 2018, Down syndrome segment held the largest share of the market, by disease indication. The highest share of Down syndrome attributes to the high prevalence of this genetic abnormality among fetuses and availability of multiple tests for its screening and diagnostics. However, the sickle cell anemia segment is expected to grow at the fastest rate during the coming year.

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Asia Pacific Prenatal & Newborn Genetic Testing Market With Latest Trends & Future Scope by 2020-2027: Indian Institutes of Technology (IITs),...

Mar 19th 2020

WE HAVE A simple message to all countries. So said Tedros Adhanom Ghebreyesus, the head of the World Health Organisation (WHO) at a news conference held in Geneva on March 16th. Test, test, test. All countries should be able to test all suspected cases, they cannot fight this pandemic blindfolded. Without adequate testing for SARS-CoV-2, the novel coronavirus that is now sweeping rapidly around the world, he said, there can be no isolation of cases and the chain of infection will not be broken. As if to prove the point, a vigorous policy of testing seems to have slowed the viruss spread in South Korea quite dramatically. And in Vo, a town in Italy, thorough and repeated testing of all 3,300 inhabitants has stopped new infections entirely.

Two main types of test are used to identify viral infections: genetic and serological. The first genetic test for SARS-CoV-2 was created just a few days after the viruss genomic sequence was published, on January 12th, by a group of Chinese researchers. Others, developed subsequently by public health bodies around the world (and also a few companies) have their own tweaks, but their broad principle is the same.

Each starts with a swab taken from the back of the nose or the throat of an individual suspected of being infected, in a search for RNAfor SARS-CoV-2 stores its genes as RNA, rather than the similar molecule, DNA, which animals such as human beings employ for the purpose. Because of this quirk, the first step of genetic testing is to copy any RNA collected into DNA, using an enzyme called reverse transcriptase. That done, the DNA is then amplified in quantity by a process called the polymerase chain reaction (PCR). The now-amplified DNA is sequenced and matched (or not) against the sequence that would be expected if the starting point was RNA from the virus.

Executed properly, genetic tests of this sort are extremely accurate. But they have limitations. One is that if the virus is present only at low levelsat the start or end of an infection, for exampletheir sensitivity drops. Also, taking a throat swab is neither simple nor foolproof. If the sampling probe goes insufficiently deeply into the orifice concerned, or fails to gather enough cells, the test might not work. Virologists say that the best sort of throat swabbing almost inevitably makes a patient gag or cough. This means that whoever is doing the swabbing needs to be protected from infection.

All this assumes that the tests themselves are designed properly. The WHO published protocols for a SARS-CoV-2 test in January, and most places which have created their own tests have based them on these instructions. In America, however, the Centres for Disease Control and Protection (CDC) designed its own protocols. Tests created using these American CDC protocols, which were distributed across the country to state-level public-health laboratories, turned out to be flawed. This no doubt contributed to Americas slower response to the unfolding crisis.

The actual apparatus used to carry out PCR tests of this sortregardless of the exact bug being tested foris commonplace in hospitals in rich countries, for it is used routinely to identify viruses from influenza to hepatitis to HIV. But the process is thereby centralised, and can be slow. It may take as long as 48 hours after a sample is collected for the result to be returned to a patient. What is needed is a test which can be conducted immediately after sampling, a process known as near-patient testing. This involves packing everything required for a testboth the instruments and the chemicalsinto a reasonably portable machine, designed specifically to look for SARS-CoV-2, that can be deployed away from a big hospital laboratory.

Several firms are working on such things. BioMrieux, a French biotechnology company, says it will have a test on offer by the end of March, and that it has an emergency-use authorisation for it from the Food and Drug Administration, which approves such devices for America. Cepheid, a Californian firm, will try to use a similar approval process to get its own coronavirus-specific test to market. This is a box, the size of a small laser printer, that ingests a sample, carries out an analysis and returns a result within a couple of hours.

Machines like these could be particularly valuable in places where public-health laboratories are few and far between. John Nkengasong, head of Africa CDC (an arm of the African Union unrelated to the American organisation of the same name), wrote in the Lancet in February of his concern about the spread of coronavirus across his continent, given the strong links between many African countries and China, the place where the pandemic began. One of his worries was the continents lack of testing capacity. At the start of 2020, only the Pasteur Institute in Senegal and the National Institute for Communicable Diseases in South Africa were able to carry out full-scale genetic detection of SARS-CoV-2.

Subsequent training, led by the WHO, has now enabled scientists in around 40 African countries to diagnose infection with the virusbut this can still be done only in each countrys central public-health laboratory. Near-patient testing would help a lot. And many health-care workers in Africa are already familiar with similar self-contained diagnostic machines, because they have been used extensively to track the efficacy of antiretroviral therapy for HIV.

Genetic tests identify active infections. But to understand properly how SARS-CoV-2 is spreading through a population it is also important to know who has been infected in the past and recovered. That is where serological tests come in. They look not for RNA in swab samples, but for antibodies in blood samples. Antibodies usually hang around in a persons bloodstream well after an infection has cleared. They thus form a historical record of the pathogens people have been exposed to over the course of their lives.

Each antibody is tailored to latch onto a specific protein on the surface of a pathogen, thus disabling it. A serological test for SARS-CoV-2 therefore works by using such a proteinreferred to as an antigento capture antibodies from a blood sample. Most tests under development focus on spike, a protein which protrudes prominently, and in many places, from the surface of the otherwise-spherical SARS-CoV-2 virus particle. In a typical test, a blood sample would be placed into a test tube coated inside with the antigen. If relevant antibodies are present, they will stick to the antigen. Depending on the design of the test, a positive result could produce a colour change or emit light to indicate success. The whole thing is reasonably cheap and could give results in minutes.

BioMedomics, a firm in North Carolina, for example, has designed a serological test for SARS-CoV-2 that needs only a few drops of blood from a finger prick, and which gives results in 15 minutes. It includes a hand-held plastic stick which looks similar to that from a pregnancy-testing kit. And, similarly to those tests, it uses coloured lines to indicate the presence of particular antibodies. The company says the test has already been widely used by Chinas public-health authorities, but has not yet been reviewed for use by Americas FDA.

Designing a serological test, then, is straightforward. Checking that it gives accurate results takes time, though. A common problem with such tests is that antibodies may cross-react, meaning that a test for SARS-CoV-2 might also show a positive result when it comes across a different coronavirusthe original SARS, perhaps, or one of the coronaviruses that cause colds. Testing the accuracy of these tests requires trials involving hundreds of people who are known to have had SARS-CoV-2 infections, and hundreds of others who are known not to have been infected.

Once validated, serological tests are fast and cheap to run at scale. They have already been deployed in China, Singapore and South Korea. Data on their efficacy, however, have not yet been publicly released or independently verified. Americas CDC is evaluating two serological tests and Public Health England, the relevant government body in that country, is also working on a test. Chris Whitty, Englands chief medical officer, said that the introduction of such a test would be a game changer in the quest to track and control the spread of SARS-CoV-2 across the population. It cannot come fast enough.

This article appeared in the Science and technology section of the print edition under the headline "Test acts"

Link:
Developing and deploying tests for SARS-CoV-2 is crucial - The Economist

With rare diseases, 72 percent out of the 7000 known are genetic, and 70 percent of those start in childhood. The lack of scientific knowledge and the quality of information often delay diagnosis or lead to misdiagnosed cases, losing precious time that can be vital to find treatment before it's too late.This situation is changing with the advent of genetic medicine. an example is Emedgene's artificial intelligence software, which is the worlds first completely automated genetic interpretation platform using machine learning algorithms.Digital Journal spoke with Einat Metzer, CEO and Co-Founder of Emedgene to talk about the new genetic interpretation software.Digital Journal: How are rare diseases classified?Einat Metzer: Rare diseases defined by the number of people affected. In the U.S., any disease that affects fewer than 200,000 people is defined as rare, in Europe, its any disease affecting fewer than 1 in 2000 people.There are around 6000 known rare diseases, and that number is growing. Whats interesting to know, is that although they are each individually rare, collectively they impact over 300 million people. Those patients have a very difficult time receiving a diagnosis for their disease, and typically go through a diagnostic odyssey lasting on average 5-7 years. Its also worth noting that most rare diseases have a genetic basis, and appear in early childhood. DJ: Is sufficient funding and research invested into rare diseases? What are the factors that influence this?Metzer: There are two challenging aspects to rare diseases, the first is the identification of a rare disease, because obviously, physicians arent familiar with every disease affecting only tens or hundreds of patients worldwide. The second difficult aspect is developing treatments for diseases impacting small numbers of patients. The good news is countries and healthcare systems are increasingly recognizing the need to cover genetic testing for the identification of rare diseases. As of today, over 50% of the US population has insurance coverage for next generation sequencing. However, even insurance coverage for the tests does not entirely solve the problem. Sequencing a patients DNA is easily done, but understanding what variants in a patients genome mean is still quite challenging. Every patient has millions of harmless genetic variants, and only one disease-causing mutation. As a result, geneticists can spend hours manually reviewing hundreds of variants and looking for evidence for the disease in databases and the literature. There are fewer than 5,000 geneticists worldwide available to interpret patients genetic data, resulting in an interpretation bottleneck. Even as more patients become eligible for genetic testing, the workforce capable of diagnosing them is not growing fast enough. We estimate the worldwide capacity of interpretation is capped at roughly 2.4 million tests, less than the predicted rare disease testing volume for 2020. DJ: How can machine learning help?Metzer:Machine learning technologies can reduce the manual labor of interpretation, by offloading both the research and deep analysis tasks from geneticists. Machine learning is a buzzword, widely used, and applied to many types of solutions. Were talking about a unique application of the technology here, where we wont use a single algorithm to solve a single problem. Instead, we need to apply a set of algorithms designed to automate different aspects of the geneticists workflow. On the one hand, the geneticists work is to review thousands of data points for every patients test, and use them to come to a conclusion on the single genetic variant thats causing the disease. We can certainly apply machine learning algorithms to review those data points. But we can go a step further, and collect the data points most likely to impact their decision, and include those in our recommendations. The second labor-intensive task geneticists perform, is looking for the most up-to-date information in databases and the published literature. Thats a task well suited for Natural Language Processing, which can be used to augment existing databases with information curated from the literature. DJ: How does Emedgenes AI software work?Metzer:Emedgenes AI-powered genomic analysis platform tries to do just that, automate the labor-intensive parts of the geneticists workflow, so interpreting a patients genetic test takes less time and effort, and accuracy is not compromised. The goal is to scale the genetic testing interpretation in healthcare systems, so they can offer personalized care to a broader population. Our AI consists of dozens of different algorithms, each solving a different problem, all coming together to automate the genetic testing interpretation workflow. The platform is able to automatically identify the disease-causing variant, compile the evidence, and present it to the geneticist on the case for review. The machine learning algorithms utilize a proprietary knowledge graph that continuously incorporates new knowledge. The knowledge graph contains over 85,000 entities and 340,000 connections today, including unique information curated from the literature that has not yet made its way into public databases.DJ: What were the main challenges when developing the software?Access to large high-quality data sets is a major challenge in developing AI solutions in healthcare in general. For our supervised learning algorithms - those that require labeled data for training the algorithm - once we obtained the data, labeling was a challenge as well. The level of education required to annotate healthcare datasets is quite high.Fortunately, there are good solutions to both problems, both from the scientific and AI perspective. DJ: Are there any case studies you can share, to show the benefits of the approach?Metzer:Weve studied the accuracy of our interpretation algorithms with Baylor Genetics. In the 180-case study, our AI successfully identified the disease-causing mutation in 96% of the cases. Another of our customers, Greenwood Genetic Center, was able to reduce time spent per case by 75%, which was translated directly into shorter turn around times for patients waiting for a genetic diagnosis.

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Q&A:Transforming genetic medicine as the medical standard of care (Includes interview) - Digital Journal

Enabling continuity of care while allowing patients to stay home

SAN CARLOS, Calif., March 19, 2020 /PRNewswire/ -- Natera, Inc.(NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced expanded access to its virtual ordering platforms and remote testing capabilities across its reproductive, oncology and organ transplant businesses.

Natera, Inc. Logo (PRNewsFoto/Natera, Inc.)

Natera's tests inform critical medical decisions, and the need to carry out these essential tests does not stop, even in these challenging times. To meet this demand, testing can be fulfilled remotely, delivered at the push of a button with virtual ordering and remote blood draws in the comfort and safety of a patient's home. "We are focused on helping physicians ensure continuity of essential medical care, while protecting the safety and well-being of our patients," said Steve Chapman, CEO.

The remote functionality is fulfilled through Natera's online platforms and a nationwide mobile blood draw network that performed roughly 10,000 in-home draws in 2019.

Natera provides essential medical services for thousands of patients every day, and our laboratories continue to operate at high throughput levels.Stringent health and safety precautions have been implemented in all of our facilities to ensure the continuity of testing operations. These include daily health checks for lab staff and a work-from-home policy for all non-lab employees.

About Natera Naterais a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide with a focus on reproductive health, oncology, and organ transplantation. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, or of our expectations of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at http://www.natera.com/investorsand http://www.sec.gov.

Contacts Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090 Media: Paul Greenland, VP of Corporate Marketing, pr@natera.com

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Natera Provides Remote Access to Tests Without Requiring Live Office Visits - Yahoo Finance

Female reproductive health relates to a condition, disease or disorder by which the reproductive system is affected, during all stages of life, unless medically intervened. In clinical practice of reproductive medicine, genetic evaluation is a standard requirement for diagnosis and management. Reproduction helps to inherit and conserve genetic identity, but genetic variations can affect reproducibility Here are some of the major concerns of reproductive health in females.

The causes of the above conditions can be genetic or non-genetic. Genetic variations can be at different resolutions of the genome, such as gross chromosomal abnormalities, single gene disorders, complex genetic inheritance or multifactorial. Chromosomal abnormalities contribute for almost 60 per cent of spontaneous abortions and the most common type is trisomy, the extra copy of chromosome and its association with advanced maternal age.

Genetic etiology in couples with a history of repeated pregnancy losses, babies with mental retardation or developmental delays is due to the presence of a balanced chromosomal translocation that gets passed in an unbalanced form to the next generation. Hence, elucidating the type of genetic abnormality can help a genetic counsellor to understand the risk of recurrence and to discuss the option of prenatal testing, if required.

Sex chromosomal abnormalities, mainly numerical followed by structural, are an important cause of menstrual disorders and therefore confirming the clinical diagnosis by doing genetic testing is utmost important. Sex chromosomal abnormalities are one of the most common findings in infertility cases, followed by the presence of a single gene disorder in the form of permutation status of Fragile X syndrome in females which can lead to premature ovarian failure and subsequent infertility.

Therefore, in couples with history of infertility, knowing the genetic status may help the couple avoid an expensive and extensive work up. It can also help the genetic counsellor and the clinician to discuss the options of reproduction to help make them an informed choice. Further, complex genetic inheritance may be the cause of polycystic ovaries and endometriosis, but large cohort study is required for fully understanding the genetic contributions to this disorder.

The results of genetic testing are not only applicable to the individual but also to the family. Hence, it not only helps the individual but also helps all the family members who are at risk.

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Women's Reproductive Health And Genetic Testing - Version Weekly

The market is estimated to grow with a CAGR of 11. 7% from 2019-2027. The factors driving the growth of genetic testing service include rising prevalence of the genetic diseases and rise in awareness & acceptance of personalized medicines.

New York, March 18, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Genetic Testing Services Market to 2027 - Global Analysis and Forecasts by Type , Disease , Service Provider and Geography" - https://www.reportlinker.com/p05875881/?utm_source=GNW Also, growing preference towards Direct-To-Consumer (DTC) genetic testing, support of government to adopt genetic testing services is positively impacting the growth of the market in the review period.

In addition, various strategic initiatives by the manufacturers, new product launch along with artificial intelligence (AI) powered genetic testing is likely to boost the growth of market.Genetic testing comprises a broad range of laboratory tests performed to analyze DNA, RNA, chromosomes, proteins, and certain metabolites using biochemical, cytogenetic, or molecular methods or a combination of these methods.The global genetic testing service market is segmented by type, disease, and service provider.Based on the type, the market is segmented into predictive testing, carrier testing, prenatal testing, newborn screening and others.

On the basis of disease, the market is classified as, cancer disease, metabolic diseases, cardiovascular diseases and others. Based on service provider, the market is categorized as, diagnostic laboratories, hospital-based laboratories and clinics.The global Genetic Testing Service market, based on disease, has been segmented into cancer, metabolic disease, and cardiovascular disease among others.In 2019, the cancer based segment held the largest share of the market.

Cancer based segment is expected to register the significant growth during the forecast period due to the rising prevalence of cancer worldwide as about 10% to 20% of all cancers are related to gene mutations that are inherited or passed down through the family.

Some of the important primary and secondary sources included in the report are, the UK Genetic Testing Network (UKGTN), the Japanese Society for Genetic Counseling (JSGC), the European Cancer Information System among others.Read the full report: https://www.reportlinker.com/p05875881/?utm_source=GNW

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

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The global genetic testing service market is expected to reach US$ 22,701.8 Mn in 2027 from US$ 9,546.2 Mn in 2019 - Yahoo Finance

SALT LAKE CITY, March 18, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, announced that the National Comprehensive Cancer Network (NCCN) updated its professional guidelines for prostate cancer to recommend biomarker-based testing for men with unfavorable intermediate and high-risk disease. Myriads Prolaris test was one of only two prognostic tests for prostate cancer recommended by NCCN for the new expanded indications and is now broadly recommended for use in low, intermediate and high-risk disease.

NCCNs endorsement of Prolaris testing in unfavorable intermediate and high-risk disease is a major step forward for men and will help in expanding access to testing, said Todd D. Cohen, M.D., vice president of Medical Affairs for Urology at Myriad Genetics. Recent data demonstrated the ability of Prolaris to determine which men will benefit from multi-modality therapy and who can avoid unnecessary morbidity associated with aggressive treatment.

In a recent study of 718 men presented at the American Society of Clinical Oncology Genitourinary Cancer Symposium in San Francisco, Myriad demonstrated the ability of Prolaris to predict which prostate cancer patients with unfavorable intermediate or high-risk disease would benefit from additional treatment. In the study, patients above the high-risk threshold saw a statistically significant benefit from multi-modality therapy leading to a reduction in the risk of metastases where patients below the high-risk threshold saw no statistical benefit from additional treatment and could avoid the morbidity associated with increased therapy.

About ProlarisProlaris is a genetic test developed by Myriad that directly measures tumor cell growth. The Prolaris test paired with both prostate-specific antigen (PSA) and Gleason provides the level of aggressiveness of a patients individual prostate cancer. PSA and Gleason only have the ability to identify how far the cancer has progressed thus far. However, when these are combined with a Prolaris test score, patients get an accurate assessment of how aggressively that cancer will progress over the next ten years. For more information visit: http://www.prolaris.com

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

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

Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to NCCNs endorsement of Prolaris testing in unfavorable intermediate and high-risk disease helping to expand access to testing; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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NCCN Updates Professional Guidelines Recommending Biomarker Testing for Unfavorable Intermediate and High-Risk Patients with Prostate CancerProlaris...

Research for novel cancer therapeutics pool in massive investments in red biotechnology market

Player leverage AI to extract potential of red biotechnology in preserving health and controlling diseases

ALBANY, New York, March 18, 2020 /PRNewswire/ -- A wide assortment of applications of genetic engineering technology, vaccine research, and biologics have helped expand the potential of the red biotechnology market, which was worth US$314.2 billion in 2018. Growing application of biotechnology in medicine has unlocked promising prospects particularly in chronic and rare diseases treatment.

Future Outlook

Emerging applications of gene therapy, pharmacogenomics, and genetic testing in the preservation of health, notably in oncology, are shaping the future growth trajectories in the red biotechnology market. By 2027-end, the revenues are projected to reach US$512 bn, clocking CAGR of ~6% from 2019 to 2027. In developing countries, many new collaborations are likely to be forged, defining future initiatives on cloud-based technology and AI.

Analysts' Viewpoint

"Staying abreast with standardized regulations and regulatory norms will enable biotechnology and pharmaceutical companies to chart new growth avenues in the red biotechnology market," note the analysts. Marked prevalence of cancer world over expands scope for market stakeholders, they further opine.

Key Takeaways of Red Biotechnology Market Study

Of the various end users, biopharmaceutical industries are anticipated to account for a promising slice of global revenues

Several drug candidates in late phase of clinical trials define growth

Gene therapy is expected to garner a promising CAGR during 2019 2027; focus on treating genetic diseases shape the growth

Of the various key regional markets, North America leads the pack; however most lucrative opportunities are found in Asia Pacific

Asian economies likely to be center of new revenue streams in Asian economies due to demand for high-quality and cost-effective drugs

Explore 176 pages of top-notch research, incisive insights, and detailed country-level projections. Gain business intelligence on Red Biotechnology Market (Application: Biopharmaceutical Production, Gene Therapy, Pharmacogenomics, and Genetic Testing; End User: Biopharmaceutical Industry, CMOs & CROs, Research Institutes, and Others) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019 - 2027 at https://www.transparencymarketresearch.com/report-toc/2063

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Red Biotechnology Market: Key Driving Factors and Promising Avenues

A few striking trends in investments in healthcare sector shape the evolution of the red biotechnology market. Growing number of clinical trials in cancer research and incessant efforts of biotechnology players to find therapies for rare diseases are boosting the pace of new drug approvals. A few statistics support research and developments in aforementioned realms.

Per the U.S.-based agency National Institutes of Health (NIH), there may be as many as 25-30 millions of Americans with a rare disease at any point in time.

According to a statistics in a recent American Cancer Society's journal, cancer mortality rate continues to drop. Red biopharmaceuticals has occupied crucial role to this end.

According to an article in NCBI, chronic diseases form the most costly health conditions in the U.S., including cancer. This is key to growing clinical trials that harness technologies in red biopharmaceutics. A case in point is cell-based vaccine technology.

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Red Biotechnology Market: Regional Outlook

Among the various regional markets, North America leads the pack, and is expected to retain its dominance throughout the assessment period. Spate of investments in clinical trials for chronic and rare diseases and massive investments in developing cancer drug pipeline have helped the North America red biotechnology market to reach dominant position. Stakeholders are harnessing artificial intelligence will continue new prospects in the regional market. Prominently, relentless efforts of biopharmaceutical players in the U.S. test new drugs and vaccines form crucial trend in the growth of this regional market.

On the other hand, a growing numbers of players have shifted their attention to Asian economies to tap into the vast latent potential in personalized healthcare. The region will see new strategic collaborations among healthcare companies and biopharmaceutical players.

Red Biotechnology Market Competition Landscape

Growing demand for biologics and biosimilars in developing economies has been crucial to the expansion of red biotechnology prospects, globally. Most notably, Asia Pacific has been the key focus for players to gain competitive edge over their peers and rivals.

Biopharmaceutical players have begun inking new partnership deals and distribution agreements in the region, particularly in on oncology therapeutics and development. Focus on novel therapeutics and disease pathways for bettering human health has been one of the key winning imperatives for companies in the red biotechnology market. To consolidate their positions, top players are aiming to expedite product approvals for rare and chronic diseases, and have increased their stakes in advanced stages of clinical trials.

A handful of big pharmaceutical and biotech players, and multinational healthcare companies jointly contribute half of the global revenues. These include Pfizer Inc., Gilead Sciences Inc., Amgen Inc., and F. Hoffmann-La Roche.

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The red biotechnology market is segmented on the basis of application, end user, and region.

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

Bioinformatics Market- The global bioinformatics market is projected to grow at a significant CAGR during the forecast period and is likely to touch a valuation of US$9.1 bn by 2018.

Gene Therapy Market -Expanding at a stellar, double-digits CAGR (Compound Annual Growth Rate) of 40% over the forecast period of 2018 to 2026, the global gene therapy market is a dizzying trajectory, marking out a rosy landscape for players operating in the playfield. As per a Transparency Market Research report, based on extensive primary and secondary research, states that over the period states, the market would accrue a worth of USD 5164.03 million a steep and impressive increase from the USD 17 million worth noted in 2017.

Biosimilars Market- Advancements in oncology settings are improving patient quality of life. Due to effective biosimilars, healthcare providers are able to receive better outcomes in several cancer patients who can opt for convenient treatments such as a painless injections rather than receiving a lengthy chemotherapy session. Patent expiry of biologic drugs for the treatment of cancer are creating a scope for incremental opportunities. As such, oncology indication segment of the biosimilars market is estimated to reach a value of~US$ 21.1 Bnby the end of2027.

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Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals.

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

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Exploring Avenues in Personalized Medical Care Defines Advances in Red Biotechnology Market: Valuation to Touch Massive US$512 Bn By 2027, Finds...

Rapid and Scalable RT-PCR Assay is Pending Approval for Emergency Use Authorization

- BGI's test already has approvals through CE-IVD and China's NMPA

- Kits are currently being distributed to more than 50 countries and regions worldwide

- Highly sensitive and quick test with 3-hour turnaround time

CAMBRIDGE, Mass., March 18, 2020 /PRNewswire/ --BGI Genomics. Co. Ltd. (SZSE:300676) and US subsidiary BGI Americas Corp., today announced that its Real-Time Fluorescent RT-PCR test for detecting SARS-CoV-2 is now commercially available in the United States. With the updated guidance from FDA issued on March 16, BGI's detection kit is eligible to be used immediately to expedite clinical testing for the novel coronavirus.

BGI is submitting a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for itsSARS-CoV-2 testand expects to receive formal EUA in the near future. BGI has been in regular communication with the FDA about its testing data since submitting information to the agency more than a week ago.

"We appreciate the FDA's move to open up the market for our diagnostic test kits," said BGI Genomics CEO Yin Ye. "Our goal is to deploy our maximum capability to support efforts to contain the virus worldwide.Our technology has been put to the test on the front lines of fighting this novel coronavirus outside the US. We are now bringing rapid and accurate testing capability at scale to bolster detection efforts throughout the US and help more patients receive accurate diagnosis."

BGI has been on the forefront of testing for SARS-CoV-2. Following the outbreak of the novel coronavirus in China, BGI was among the first few companies that developed the diagnostic test that received emergency approval from China's National Medical Products Administration (NMPA) on January 26, 2020, followed by CE-IVD marking on March 2, 2020. BGI quickly scaled up manufacturing and currently has a daily capacity of up to 300,000 reactions per day. BGI has performed over 500,000 SARS-CoV-2 tests in its own central laboratories in China and is distributing its SARS-CoV-2 detection kits to more than 50 countries and regions around the world.

BGI is bringing its full genomics expertise and resources to the fight against the 2019 novel coronavirus around the world. BGI's long history of responses to public health crisis events includes decoding the genome of the SARS virus in 2003 and developing the virus detection kit in 96 hours, and helping fight the Ebola outbreak in 2014 in West Africa, where BGI quickly set up a front-line laboratory in Sierra Leone and helped the local team to develop Ebola virus detection kits.

About EUA

The Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV has not been FDA cleared or approved. However, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition, as in the case of the novel coronavirus when the secretary of the U.S. Department of Health and Human Services (HHS) declares a public health emergency. HHS Secretary Alex Azar declared an emergency for COVID-19 on January 31. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About BGI Genomics Co Ltd.

BGIwas founded in 1999 with the vision of using genomics to benefit humanity and has since become one of the largest genomics organizations in the world. With a focus on research and applications in the healthcare, pharmaceutical, conservation and environmental fields, BGI has a proven track record of innovative, high-profile research that has generated over 1,600 publications. BGI Genomics is an independent division of BGI Group and was listed on theShenzhen Chi-Next exchange inJuly 2017. BGI Genomics' goal is to make state-of-the-art genomics highly accessible to the global research community and clinical markets by integrating the industry's broadest array of leading technologies, including BGI's own DNBSEQ technology platforms, economies of scale, and expert bioinformatics resources. BGI Genomics also offers a wide portfolio of transformative genetic testing products across major diseases, enabling medical providers and patients worldwide to realize the promise of genomics-based diagnostics and personalized healthcare.

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SOURCE BGI

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BGI's RT-PCR SARS-CoV-2 Test to Detect Novel Coronavirus Now Commercially Available for Clinical Use in the United States - Yahoo Finance

DUBLIN, March 18, 2020 /PRNewswire/ -- The "US Female Infertility Diagnosis And Treatment Market 2019-2025" report has been added to ResearchAndMarkets.com's offering.

The US female infertility diagnosis and treatment market is expected to witness a significant growth with the CAGR of 3.8% during the forecast period.

The US Female infertility diagnosis and treatment diagnosis and treatment market is growing significantly due to various factors such as increasing infertility rate among females, unhealthy lifestyle and development of new technologies in IVF treatment. Apart from these factors, the rising trend of surrogacy in the country is also driving the growth of the market. According to the American Pregnancy Association in 2017, infertility affects around 6 million American couples, which corresponds to around 10% of American females of childbearing age. In addition, around 25% of infertile couples have more than one cause of infertility. The growing infertility rate creates the demand for infertility diagnosis and treatment, which in turn, drives the market growth.

The US Female infertility diagnosis and treatment market is segmented on the basis of diagnosis, treatment type, and end-user. Based on the diagnosis, the market is segmented into ovulation testing, hysterosalpingography (HSG), hysteroscopy, imaging testing, ovarian reserve testing, hormonal level testing, genetic testing, and others (laparoscopy). Based on the treatment type, the market is segmented into drugs, surgery, intrauterine insemination (IUI), and assisted reproductive technology (ART). Based on the end-user, the market is segmented into hospitals and clinics, homecare, and pathology and diagnostic center.

Some of the major players operating in the US female infertility diagnosis and treatment market include Abbott Laboratories, Inc., Merck KGaA, Cipla Ltd., and others. These players adopt various organic and inorganic growth strategies such as merger and acquisition and product launch to strengthen their presence in The US market.

The report covers:

Key Topics Covered

1. Report Summary1.1. Research Methods and Tools1.2. Market Breakdown1.2.1. By Segments

2. Market Overview and Insights2.1. Scope of the Report2.2. Analyst Insight& Current Market Trends2.2.1. Key Findings2.2.2. Recommendations2.2.3. Conclusion2.3. Rules & Regulations

3. Competitive Landscape3.1. Company Share Analysis3.2. Key Strategy Analysis3.3. Key Company Analysis

4. Market Determinants4.1. Motivators4.2. Restraints4.3. Opportunities

5. Market Segmentation5.1. The US Female Infertility Diagnosis and Treatment Market by Diagnosis5.1.1. Ovulation Testing5.1.2. Hysterosalpingography (HSG)5.1.3. Hysteroscopy5.1.4. Imaging Testing5.1.5. Ovarian Reserve Testing5.1.6. Hormonal Level Testing5.1.7. Genetic Testing5.1.8. Others (Laparoscopy)5.2. The US Female Infertility Diagnosis and Treatment Market by Treatment5.2.1. Drugs5.2.2. Surgery5.2.3. Intrauterine Insemination (IUI)5.2.4. Assisted Reproductive Technology (ART)5.3. The US Female Infertility Diagnosis and Treatment Market by End-User5.3.1. Hospitals and Clinics5.3.2. Homecare5.3.3. Pathology and Diagnostic Centers

6. Company Profiles6.1. Church & Dwight Co.6.2. Cook Group Inc.6.3. Eli Lilly Co.6.4. Fairhaven Health, LLC6.5. FUJIFILM Irvine Scientific, Inc.6.6. Millendo Therapeutics, Inc.6.7. Pfizer Inc.6.8. Princeton BioMeditech Corp6.9. Bayer AG6.10. Church & Dwight Co. Inc.6.11. Vitrolife6.12. Cook Medical, Inc.6.13. Eli Lilly & Co.

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The US Female Infertility Diagnosis & Treatment Market to 2025 - Contains End-user Insights for Hospitals & Clinics, Homecare, and Pathology...