Archive for the ‘Genetic Testing’ Category

Preimplantation Genetic Testing Market 2020 Analysis by Segments, Share, Application, Development, Growing Demand, Regions, Top Key Players & Forecast 2025

The global preimplantation genetic testing market report covers deep insights of various vital aspects of the market. The Global preimplantation genetic testing market research report delivers deep insights about the different market segments based on the end-use, types and geography.

Moreover, in past few years, the market of preimplantation genetic testing has recorded a significant development and is anticipated to further rise.

Top Leading Key Players are:

Thermo Fisher Scientific, Inc., Agilent Technologies, Inc., PerkinElmer, Inc., CooperSurgical, Inc., Beijing Genomics Institute (BGI), Abbott Laboratories, Natera, Inc., Genea Limited, Rubicon Genomics, Inc. and Oxford Gene Technology

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Market research report for every industry is based on various important factors, for example demand & supply, market trends, revenue growth patterns and market shares. Report on the Global preimplantation genetic testing market is made after a comprehensive research conducted by a systematized methodology.

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Global Preimplantation Genetic Testing Market is segmented based by type, application and region.

Based on Type, the market has been segmented into:

by Test Type (Aneuploidy, Structural Chromosomal Abnormalities, Single Gene Disorders, X-linked Disorders, HLA Typing, Gender Identification) and Technology (Next Generation Sequencing, Polymerase Chain Reaction, Fluorescent In-Situ Hybridization, Comparative Genomic Hybridization, Single Nucleotide Polymorphism)

One of the most crucial feature of any report is its geographical segmentation of the market that consists of all the key regions. This section majorly focuses over several developments taking place in the region including substantial development and how are these developments affecting the market.

Regional analysis provides a thorough knowledge about the opportunities in business, market status& forecast, possibility of generating revenue, regional market by different end users as well as types and future forecast of upcoming years.

The key factor important for making any new business effective is advancement or making impactful modifications in the business. Report on Global preimplantation genetic testing market, is an extensive papers that covers all the aspects of the market analysis and enables a comprehensive summary to its readers.

In a nutshell, the preimplantation genetic testing market research reports is a one-stop solution for all requirements by the in-house experts.

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New study: Preimplantation Genetic Testing Market interpreted by a new report - WhaTech Technology and Markets News

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

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

The global TB epidemic

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

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

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

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

Challenges of mycobacteria detection

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

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

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

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

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

Clinical impact of molecular testing

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

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

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

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

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

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

Future outlook for mycobacteria

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

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

References

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Q: What are you most grateful for?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Michelle Kuppersmith's doctor recommended a bone marrow biopsy after suspecting she had a rare blood disorder. Though the biopsy was done by an in-network provider at an in-network hospital, Kuppersmith learned she was on the hook for $2,400 for out-of-network genetic profiling. Shelby Knowles for KHN hide caption

Michelle Kuppersmith's doctor recommended a bone marrow biopsy after suspecting she had a rare blood disorder. Though the biopsy was done by an in-network provider at an in-network hospital, Kuppersmith learned she was on the hook for $2,400 for out-of-network genetic profiling.

Michelle Kuppersmith feels great, works full time and exercises three to four times a week. So she was surprised when a routine blood test found that her body was making too many platelets, which help control bleeding.

Kuppersmith's doctor suspected the 32-year-old Manhattanite had a rare blood disorder called essential thrombocythemia, which can lead to blood clots, strokes and, in rare cases, leukemia.

Her doctor suggested a bone marrow biopsy, in which a large needle is used to suck out a sample of the spongy tissue at the center of the patient's hip bone.

Doctors examine the bone marrow under a microscope and analyze the DNA. The procedure allows doctors to judge a patient's prognosis and select treatment, if needed. Kuppersmith had heard the procedure can be intensely painful, so she put it off for months.

The biopsy performed by a provider in her insurance network, at a hospital in her network lasted only a few minutes, and Kuppersmith received relatively good news.

While a genetic analysis of her bone marrow confirmed her doctor's suspicions, it showed that the only treatment she needs, for now, is a daily, low-dose aspirin. She will check in with her doctor every three to four months to make sure the disease isn't getting worse.

All in all, Kuppersmith felt relieved.

Then she got a notice saying her insurer refused to pay for the genetic analysis, leaving her responsible for a $2,400 payment.

The patient: New York resident Michelle Kuppersmith, 32, who is insured by Maryland-based CareFirst Blue Cross Blue Shield. She works as director of special projects at a Washington-based watchdog group. Because she was treated in New York, Empire Blue Cross Blue Shield which covers that region handled part of her claim.

Total amount owed: $2,400 for out-of-network genetic profiling

The providers: Kuppersmith had her bone marrow removed at the Mount Sinai Ruttenberg Treatment Center in New York City, which sent her biopsy sample to a California lab, Genoptix, for testing.

Medical services: Bone marrow biopsy and molecular profiling, which involves looking for genetic mutations

What gives: The field of molecular diagnostics, which includes a variety of gene-based testing, is undergoing explosive growth, said Gillian Hooker, president of the National Society of Genetic Counselors and vice president of clinical development for Concert Genetics, a health IT company in Nashville, Tennessee.

A report from Concert Genetics, a company that helps clients manage genetic testing, found there are more than 140,000 molecular diagnostic products on the market, with 10 to 15 added each day.

The field is growing so quickly that even doctors are struggling to develop a common vocabulary, Hooker said.

Kuppersmith underwent a type of testing known as molecular profiling, which looks for DNA biomarkers to predict whether patients will benefit from new, targeted therapies. These mutations aren't inherited; they develop over the course of a patient's life, Hooker said.

Medicare spending on molecular diagnostics more than doubled from 2016 to 2018, increasing from $493 million to $1.1 billion, according to Laboratory Economics, a lab industry newsletter.

Charges range from hundreds to thousands of dollars, depending on how many genes are involved and which billing codes insurers use, Hooker said.

Based on Medicare data, at least 1,500 independent labs perform molecular testing, along with more than 500 hospital-based labs, said Jondavid Klipp, the newsletter's publisher.

In a fast-evolving field with lots of money at stake, tests that a doctor or lab may regard as state-of-the-art an insurer might view as experimental.

Worse still, many of the commercial labs that perform the novel tests are out-of-network, as was Genoptix.

Stephanie Bywater, chief compliance officer at NeoGenomics Laboratories, which owns Genoptix, said that insurance policies governing approval have not kept up with the rapid pace of scientific advances. Kuppersmith's doctor ordered a test that has been available since 2014 and was updated in 2017, Bywater said.

Although experts agree that molecular diagnostics is an essential part of care for patients like Kuppersmith, doctors and insurance companies may not agree on which specific test is best, said Dr. Gwen Nichols, chief medical officer of the Leukemia & Lymphoma Society.

Tests "can be performed a number of different ways by a number of different laboratories who charge different amounts," Nichols said.

Insurance plans are much more likely to refuse to pay for molecular diagnostics than other lab tests. Laboratory Economics found Medicare contractors denied almost half of all molecular diagnostics claims over the past five years, compared with 5-10% of routine lab tests.

With so many insurance plans, so many new tests and so many new companies, it is difficult for a doctor to know which labs are in a patient's network and which specific tests are covered, Nichols said.

"Different providers have contracts with different diagnostic companies," which can affect a patient's out-of-pocket costs, Nichols said. "It is incredibly complex and really difficult to determine the best, least expensive path."

Kuppersmith said she has always been careful to check that her doctors accept her insurance. She made sure Mount Sinai was in her insurance network, too. But it never occurred to her that the biopsy would be sent to an outside lab or that it would undergo genetic analysis.

She added: "The looming threat of a $2,400 bill has caused me, in many ways, more anxiety than the illness ever has."

The resolution: Despite making dozens of phone calls, Kuppersmith got nothing but confusing and contradictory answers when she tried to sort out the unexpected charge.

An agent for her insurer told her that her doctor hadn't gotten preauthorization for the testing. But in an email to Kuppersmith, a Genoptix employee told her the insurance company had denied the claim because molecular profiling was viewed as experimental.

A spokesperson for New York-based Empire Blue Cross Blue Shield, which handled part of Kuppersmith's claim, said her health plan "covers medically necessary genetic testing."

New York, one of 28 states with laws against surprise billing, requires hospitals to inform patients in writing if their care may include out-of-network providers, said attorney Elisabeth Benjamin, vice president of health initiatives at the Community Service Society, which provides free help with insurance problems.

A spokesperson for Mount Sinai said the hospital complies with that law, noting that Kuppersmith was given such a document in 2018 nearly one year before her bone marrow biopsy and signed it.

Benjamin said that's not OK, explaining: "I think a one-year-old, vague form like the one she signed would not comply with the state law and certainly not the spirit of it."

Instead of sending Kuppersmith a bill, Genoptix offered to help her appeal the denied coverage to CareFirst. At first, Genoptix asked Kuppersmith to designate the company as her personal health care representative. She was uncomfortable signing over what sounded like sweeping legal rights to strangers. Instead, she wrote an email granting the company permission to negotiate on her behalf. It was sufficient.

A few days after being contacted by KHN, Kuppersmith's insurer said it would pay Genoptix at the in-network rate, covering $1,200 of the $2,400 charge. Genoptix said it has no plans to bill Kuppersmith for the other half of the charge.

The takeaway: Kuppersmith is relieved her insurer changed its mind about her bill. But, she said: "I'm a relatively young, savvy person with a college degree. There are a lot of people who don't have the time or wherewithal to do this kind of fighting."

Patients should ask their health care providers if any outside contractors will be involved in their care, including pathologists, anesthesiologists, clinical labs or radiologists, experts said. And check if those involved are in-network.

"Try your best to ask in advance," said Jack Hoadley, a research professor emeritus at Georgetown University. "Ask, 'Do I have a choice about where [a blood or tissue sample] is sent?'"

Ask, too, if the sample will undergo molecular diagnostics. Since the testing is still relatively new and expensive most insurers require patients to obtain "prior authorization," or special permission, said Dr. Debra Regier, a medical geneticist at Children's National Hospital in Washington and an associate with NORD, the National Organization of Rare Diseases. Getting this permission in advance can prevent many headaches.

Finally, be wary of signing blanket consent forms telling you that some components of your care may be out-of-network. Tell your provider that you want to be informed on a case-by-case basis when an out-of-network provider is involved and to consent to their participation.

Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have a perplexing medical bill you want to share with us? Tell us about it here.

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Bill Of The Month: Pricey Genetic Test For Essential Thrombocythemia : Shots - Health News - NPR

This is a very exciting era in laboratory medicine as virtually every day new genetic tests and emerging laboratory technologies enter the market. With these advancements also comes the (fun) challenge of distinguishing clinical testing from research testing. Making this distinction matters in two key ways. First, from a regulatory standpoint, it would be financially irresponsible to bill patients and insurers for research testing. Second, in terms of clinical implications, we have to demonstrate the value of classifying variants (clinical validity), then show that variant classification impacts patient clinical outcomes (clinical utility). Laboratory test stewardship programs provide an important foundation for striking an appropriate balance between implementing new genetic tests and meeting standards for clinical validity and utility, paying particular attention to the size of genetic panels.

Since the 1980s, identification of genetic markers has supported tailored clinical diagnoses and therapies, and as such, genetic testing has become an attractive diagnostic tool. Single gene testing has progressed to more expansive gene panels, exome, and even genome sequencing. While novel technologies provide the potential for increased efficiency, more comprehensive analysis, and reduced invasive testing to guide clinical care, the financial impact and potential secondary findings of these methods necessitate a balanced approach to responsibly implement precision medicine in clinical practice.

To be good laboratory testing stewards, we must address questions about the value of new and emerging technologies. Simply defined, value is the quality of a test divided by its cost. While mathematical equations are straightforward precisely because they are objective, the perspective of value varies for each stakeholder (patients, providers, laboratorians, and payers), and these perspectives often have competing interests.

A crucial consideration is the timeline in which novel technologies are implemented clinically and, perhaps even more challenging, the elements that distinguish research testing from clinical testing. Clinical testing (for all laboratory tests) encompasses analytical validity, clinical validity, and demonstrated clinical utility. In some cases, genetic tests are Food and Drug Administration (FDA)-cleared for specific clinical applications. Patients and insurers typically are responsible for the cost of clinical testing. As new assays appear on the market, they might demonstrate analytical validity, but lack evidence establishing clinical validity and utility.

Requiring patients or insurers to cover the cost of building this evidence for a new assay is contrary to laboratory stewardship principles. Lab stewards have the difficult task of distinguishing true research from ancillary testing. Advancing research and providing evidence of clinical validity and clinical utility remain critical for enhancing our overall understanding of genetic testing. One approach to balancing both needs is to find alternative funding for clinical research in order to achieve alignment with insurers while also supporting patients.

It goes without saying that strict standards for validation and documentation exist for clinical testing, and although only a minority of tests are FDA-cleared, all laboratory developed tests must adhere to CLIA regulations. This is a minimum standard; even laboratories that perform research-use only testing and return results to participants must have a CLIA license. Compliance with CLIA regulations is not the only factor in assessing a laboratorys or tests quality. Evaluating a laboratorys comprehensive services also matters, including its result reporting processes, adherence to professional society guidelines, report formatting, test billing, and sample coordination logistics.

When adopting new genetic tests, a second consideration is the size of a panel. A bigger panel with more genes or genetic markers does not necessarily improve diagnostic clarity. With an increased number of assayed genes comes greater potential for variants of uncertain significance (VUS). These variants can be particularly challenging because genomics is still relatively new and we collectively lack sufficient data to confidently classify variants as pathogenic or benign. In the absence of evidence supporting these classifications, laboratories assign variants to a VUS holding cell category. Once sufficient evidence arises, variants originally classified as VUS will be upgraded (to pathogenic or likely pathogenic) or downgraded (to benign or likely benign).

One would predict that approximately half of all VUS would be upgraded and half downgraded. However, in what is termed the VUS paradox, there is significant discordance between the expected and observed reclassification of variants. It is much more common for VUS to be reclassified as benign or likely benign (downgraded) than to be upgraded (1). Given the large body of evidence demonstrating that VUS can cause patient harm, labs act irresponsibly if they inappropriately classify variants as VUS. As laboratory stewards, we need to ensure that any gene panel ordered is the best fit for the clinical question at hand instead of using an inappropriately large gene panel likely to result in challenging VUS.

From the perspectives of patients and insurers, it is critical to demonstrate how outcomes will improve as a result of using this new technology. Are these new tests preforming better than current standard of care? In many cases, additional evidence is needed before a test is offered broadly. The following examples in cancer and prenatal settings highlight the promise of novel technologies and questions that should be considered before adopting/implementing more broadly.

Cell-free DNA screening was launched in 2012 and meta-analyses have demonstrated superior performance for detecting chromosomal aneuploidies such as Down syndrome relative to existing maternal serum screening tests like the combined and fully integrated screening tests. Since then, cell-free DNA prenatal screening has expanded rapidly, including the recent ability to detect all aneuploidies and even sub-chromosomal copy number alterations such as microdeletions and microduplications.

From a consumer perspective, cell-free DNA prenatal screening is appealingits less invasive than diagnostic testing like amniocentesis and can reveal a babys sex in the first trimester of pregnancy. However, this new modality remains a screening test and actually can complicate decision-making when used as a diagnostic test. This is because it tests both maternal and fetal cell-free DNA and uncovers findings that can be difficult to interpret.

For example, numerous cases have been reported of detecting unknown maternal cancer, which is called occult maternal malignancy. If a cell-free DNA prenatal screen identifies a potential maternal cancer, the affected patient necessarily will embark on a diagnostic hunt for a tumor during an already difficult period of pregnancy. This can be challenging from an insurers perspective as well because finding a tumor based on cell-free DNA prenatal screening results might necessitate expensive imaging studies.

While there is great promise in expanding the technology of cell-free DNA to detect single-gene Mendelian disorders, the American College of Obstetricians and Gynecologists has issued a practice advisory that, there has not been sufficient information regarding accuracy and positive and negative predictive value ... [and thus,] single-gene cell-free DNA screening is not currently recommended in pregnancy (2).

The pace at which new technology is being developed and implemented in clinical settings will undoubtedly stay in the fast lane. As such, laboratorians need to consider how to best integrate novel technologies into clinical practice (or not), striking a responsible balance between true clinical research and ancillary testing.

Using alternate funding sources for clinical research, including risk-sharing partnerships with insurers, has proven successful and may pave the way for clinical research to become true clinical testing. Practice guidelines are extremely valuable but often lag behind advances in technology precisely because they require a high burden of published evidence. An institutional approach utilizing an oversight committee, such as a laboratory stewardship committee, is an effective vehicle for evaluating implementation of new technologies and shifting appropriately from research to clinical testing when sufficient evidence exists for clinical validity and utility.

The genomic testing era is very exciting, and responsibly implementing a collaborative stewardship program is critical for ensuring that we offer the right test to the right patient at the right time.

Tina Lockwood, PhD, DABCC, DABMGG, is an associate professor in the department of laboratory medicine and director of the genetics and solid tumor diagnostics laboratory at the University of Washington in Seattle.+Email: tinalock@uw.edu

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Lab Stewardship in the Era of Genomic Testing - American Association for Clinical Chemistry (AACC)

LOS ANGELES (CBSLA) A settlement has been reached with a Chinese genetic testing company over allegations it advertised and sold at-home COVID-19 testing kits that lacked FDA approval.

Los Angeles City Attorney Mike Feuer filed suit against Yikon Genomics, seeking a court order that directs the company to stop marketing and selling the test kits plus fines for each alleged violation. Feuer announced Monday it had reached a settlement with the company.

Yikon Genomics had touted a $39 test that promised to deliver a result in 15 minutes. The company claimed the Corona Virus At-Home Test Kit was approved by the U.S. Food and Drug Administration.

The FDA has not approved any coronavirus home test kits.

If consumers have a home test kit that hasnt been approved by the FDA, and is not likely to work properly, they might not get reliable results, and they might unknowingly expose others to this virus, Feuer said at a news conference.

Yikon Genomics, which primarily does genetic and in-vitro fertilization testing, agreed to pull its product from the market and refund anyone who purchased it.

The coronavirus outbreak and inability for most people to obtain a test has given rise to a number of coronavirus-related scams, including ones related to stimulus checks, donations, investments, inspections and fake home tests.

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LA City Attorney Settles With Chinese Genetic Company Over COVID-19 Home Test Claiming To Have FDA Approval - CBS Los Angeles

Dublin, April 06, 2020 (GLOBE NEWSWIRE) -- The "U.S. Hematologic Malignancies Testing Market: Focus on Product, Disease, Technology, End User, Country Data and Competitive Landscape - Analysis and Forecast, 2018-2025" report has been added to ResearchAndMarkets.com's offering.

This report projects the market to grow at a significant CAGR of 14.60% during the forecast period, 2019-2025. The U.S. hematologic malignancies market generated $723.9 million revenue in 2018, in terms of value.

The U.S. hematologic malignancies market growth has been primarily attributed to the major drivers in this market, such as rising incidence of hematologic malignancies, favorable reimbursement scenario, and increase in funding in the hematologic malignancies market. However, there are factors hindering the growth of the market, such as lack of training professionals, high pricing pressure, and issue pertaining to the analytic validity of genetic testing.

Key Questions Answered in this Report:

Market Segmentation

Key Companies in the U.S. Hematologic Malignancies Market

The key manufacturers that have been contributing significantly to the U.S. hematologic malignancies market include Abbott Laboratories, Illumina, Inc., F. Hoffmann-La Roche Ltd, Bio-Rad Laboratories, Inc., Sysmex Corporation, Cancer Genetics Inc., QIAGEN N.V., ICON plc, Quest Diagnostics Incorporated, Invitae Corporation, Opkp Health, Laboratory Corporation of American Holdings, NeoGenomics Laboratories, Inc., ASURAGEN, INC., ArcherDX, Inc., Adaptive Biotechnologies, ARUP Laboratories, and Invivoscribe, Inc, among others.

Key Topics Covered:

1 Product Definition

2 Market Scope

3 Research Methodology

4 Epidemiology of Hematological Malignancies in U.S.

5 U.S. Hematologic Malignancies Testing Market: Value and Volume Data 2019 (U.S. State Regions)5.1 Midwest U.S.5.2 Mid Atlantic5.3 The Southwest5.4 New England5.5 The West5.6 The South

6 Market Dynamics6.1 Market Drivers6.1.1 Rising Incidence of Hematologic Malignancies6.1.2 Increasing Adoption of Inorganic Growth Strategies in the Market6.1.3 Favorable Reimbursement Scenario in the U.S. hematologic Malignancies Testing Market6.1.4 Increase in Funding in Hematologic Malignancies Testing Market6.2 Restraints6.2.1 High Pricing Pressure6.2.2 Lack of Trained Professionals6.2.3 Issues Pertaining to the Analytical Validity of Genetic Testing for Cancers6.3 U.S. Market Opportunities6.3.1 An Underlying Relaxation in Revised 2018 PAMA Criteria6.3.2 Informatics and Technological Innovation for Larger Consumer Base6.3.3 Technological Advancements in the Field of Molecular Diagnostics

7 Competitive Landscape7.1 Key Strategies and Developments7.1.1 Synergistic Activities7.1.2 Approvals7.1.3 Product Launches and Enhancements7.1.4 Merger, Acquisitions & Expansions7.2 Product Scenario7.3 Funding Scenario7.4 Market Share Analysis7.5 Growth Share Analysis (Opportunity Mapping)7.5.1 By Company7.5.2 By Product

8 Industry Insights8.1 Regulatory Framework8.1.1 Legal Requirements and Framework in the U.S.8.2 Reimbursement Scenario8.2.1 Protecting Access to Medicare Act (PAMA) Criteria for Advanced Diagnostic Laboratory Tests (ADLT)8.3 Physicians' Perceptions

9 U.S. Hematologic Malignancies Testing Market (by Product) 2018-2025 ($ Million)9.1 Services9.2 Kits9.2.1 NGS-Based Gene Panels9.2.1.1 Leukemia9.2.1.2 Lymphoma9.2.1.3 Multiple Myeloma9.2.1.4 Myeloproliferative Neoplasms9.2.1.5 Myelodysplastic Syndromes9.2.2 NGS-Based Molecular Clonality Testing9.2.2.1 Leukemia9.2.2.2 Lymphoma9.2.2.3 Multiple Myeloma9.2.2.4 Myeloproliferative Neoplasms9.2.2.5 Myelodysplastic Syndromes9.2.3 NGS-Based Translocation Testing9.2.3.1 Leukemia9.2.3.2 Lymphoma9.2.3.3 Multiple Myeloma9.2.3.4 Myeloproliferative Neoplasms9.2.3.5 Myelodysplastic Syndromes9.2.4 NGS-Based Mutation Testing9.2.4.1 Leukemia9.2.4.2 Lymphoma9.2.4.3 Multiple Myeloma9.2.4.4 Myeloproliferative Neoplasms9.2.4.5 Myelodysplastic Syndromes9.2.5 NGS-Based Minimal Residual Disease (MRD) Testing9.2.5.1 Leukemia9.2.5.2 Lymphoma9.2.5.3 Multiple Myeloma9.2.5.4 Myeloproliferative Neoplasms9.2.5.5 Myelodysplastic Syndromes

10 U.S. Hematologic Malignancies Testing Market (by End User)10.1 Specialty Clinics and Hospitals10.2 Diagnostic Laboratories10.3 Reference Laboratories10.4 Research Institutions

11 U.S. Hematologic Malignancies Testing Market (by Disease)11.1 Leukemia11.2 Lymphoma11.3 Multiple Myeloma11.4 Myeloproliferative Neoplasms11.5 Myelodysplastic Syndromes

12 U.S. Hematologic Malignancies Testing Market (by Technology)12.1 Next-generation Sequencing (NGS)12.2 Polymerase Chain Reaction (PCR)12.3 Fluorescence In-Situ Hybridization (FISH)12.4 Immunohistochemistry (IHC)12.5 Flow Cytometry12.6 Other Technologies

13 Company Profiles

Story continues

Companies Mentioned

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United States Hematologic Malignancies Testing Industry (2018 to 2025) - Featuring Illumina, Invitae Corporation & Invivoscribe Among Others -...

Unlike some countries, we didnt go into this crisis with a huge diagnostics industry. We have the best scientific labs in the world, but we did not have the scale, Matt Hancock said this week, facing a barrage of questions on why the UK is lagging behind others on coronavirus testing.

The UKs health secretary said his German counterpart could call on 100 test labs and rely on the heavy presence of Roche, one of the worlds largest diagnostics companies, to achieve its current level of more than 50,000 tests a day. The UK had had to build from a lower base, he said.

Industry players say this is a fair characterisation. We have a lot of diagnostics capability in this country but what we dont have is the global diagnostics giants, said Tony Cooke of Cambridge Clinical Laboratories. Even when we have our own companies, a lot of the supplies are coming from the US or Germany.

The UK is not alone in struggling to meet demand. France has carried out even fewer tests than the UK, and Spain tried to bridge supply chain issues by buying millions of test kits from China that later had to be withdrawn after giving flawed results.

As well as Roche, which has developed a single machine that can churn out 1,000 test results a day, Germany also has Qiagen, a major supplier of genetic testing kits, which are being used to diagnose Covid-19. Both companies also produce reagents and components used in kits put together by other manufacturers. The US has called on Abbott, Thermofisher, Quest Diagnostics and Hologic.

The more distributed hospital lab system in countries such as Germany and Italy has also served them well in being able to increase testing for Covid-19. The NHS has spent years centralising its testing labs, which under normal circumstances was both economical and clinically robust. It has allowed labs to be aligned to standard diagnostic criteria and to use the same test kits, reagents and equipment from the same suppliers, allowing bulk purchases from single suppliers at a competitive price.

During a pandemic, however, this dependency on a handful of non-domestic suppliers, such as Roche, for kits and reagents becomes a fundamental flaw.

Allan Wilson, the president of the Institute of Biomedical Science, says the UK could have done a better job of surveying its diagnostic landscape and built a strategy around existing strengths, which include having a large number of research labs and smaller, but highly innovative diagnostics companies.

The re-engineering of HIV testing machines into 90-minute Covid-19 tests by Diagnostics for the Real World in Cambridge, which within a week will meet the entire testing requirements of Addenbrookes hospital in the city, is an example of the type of approach that could have been encouraged nationally.

We were slow to make that decision in testing and we approached it in too narrow a perspective, said Wilson. Were doing it regional locally, people forming and forging partnership arrangements, looking for support from universities and commercial companies.

Industry figures say that more could be done in future to nurture some of these startups and medium-sized companies into home-grown giants.

There is a record to show that innovative businesses started in the UK have this potential, but that beyond a certain level of success the companies tend to migrate to the US where venture capital and buyers are in more ready supply.

Medisense, which was spun out of Oxford University in the 1990s, revolutionised the blood glucose sensing industry in the 1990s, then was acquired by the US company Abbott. Solexa, a genetic sequencing company spun out of Cambridge, was acquired by Illumina in the US for about $650m in 2007 and is now worth about $40bn.

Gordon Sanghera, the chief executive of the sequencing and diagnostics company Oxford Nanopore, whose technology was used to characterise the very first example of the coronavirus in Wuhan, said Hancocks acknowledgement of the need to nurture a domestic industry was welcome and should not be forgotten after the crisis has passed.

Hancocks declaration that the UK needs a new diagnostic industry is right, and we have plenty of seeds, he said. Its the collaboration with the broader scientific community, and looking at access to capital for UK companies, that will make those seeds grow and bear fruit that helps people not only in the UK, but all around the world.

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Why has the UK lagged behind in testing for the coronavirus? - The Guardian

Apr 2nd 2020

Editors note: The Economist is making some of its most important coverage of the covid-19 pandemic freely available to readers of The Economist Today, our daily newsletter. To receive it, register here. For more coverage, see our coronavirus hub

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.

Dig deeper:

For our latest coverage of the covid-19 pandemic, register for The Economist Today, our daily newsletter, or visit our coronavirus hub

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

Originally posted here:
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.

Dear reader,

As your local news provider, we have the duty of keeping you factually informed on Covid-19 developments.

As you may have noticed, mis- and disinformation (also known as fake news) is circulating online. Caxton Local Media is determined to filter through the masses of information doing the rounds and to separate truth from untruth in order to keep you adequately informed

Local newsrooms follow a strict pre-publication fact-checking protocol.

A national task team has been established to assist in bringing you credible news reports on Covid-19.

Readers with any comments or queries may contact National Group Editor Irma Green ([emailprotected]) or Legal Adviser Helene Eloff ([emailprotected])

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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

SOURCE NxGen MDx

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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