Diagnostic Tests

Zacks Investment Research Downgrades OraSure Technologies (NASDAQ:OSUR) to Sell | 8/11/2020

… report issued on Friday, Zacks.com reports. According to Zacks, “OraSure Technologies, Inc. develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests , and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians …

There are 10 coronavirus tests you can use from home. Here’s how they work and where to order one. | Business Insider | 8/11/2020

… a spokesperson. Fulgent Genetics, another testing group, said it’s processing thousands of the tests per day. LabCorp, the first healthcare company to get the at-home kits authorized , has run more than 4 million diagnostic tests since March, though that number includes those carried out at testing locations as well, a spokesperson told BI. The at-home tests are similar in their sensitivity, or ability to detect coronavirus-positive samples …

Follow Diagnostic Tests:    

10 healthcare execs on public health education amid the pandemic | Becker’s Hospital Review | 8/11/2020

… may follow in the coming months or years. New federal guidelines have lifted restrictions on nonessential procedures, allowing hospitals to welcome more patients back for follow-up appointments, elective procedures and cancer screening and diagnostic tests . It is our responsibility to reassure people that if they have had growing concerns about their cancer risk or have symptoms of concern, now is the time to consult their doctor. It is important …

State of Maryland Allows Point-of-Care Testing for COVID-19; Quidel Expands Training Program | Business Wire | 8/11/2020

… answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio and to explore exciting employment opportunities, visit quidel.com . Forward-Looking Statements …

San Bernardino County surpasses 35,000 COVID-19 cases, reports 49 new deaths since Friday | 8/10/2020

… Friday, bringing the county’s confirmed coronavirus cases to 35,712. The county has the fourth-highest case total in the state, and has 546 virus-related deaths. The county reported on Sunday that 11,229 coronavirus diagnostic tests had been conducted in the past 24 hours, a 73% increase from the prior day. County officials could not immediately comment on the sudden reported increase in testing. Over the past week, the county …

INTERVIEW. Coronavirus: “The second wave will look different” | 8/10/2020

… possible. It is this type of relationship that can be established. Especially since the mayors have just been elected, they have the confidence of the population. How to test faster and better? The reference diagnostic tests remain the nasopharyngeal PCR tests. Effective saliva tests would be very helpful, but they lack sensitivity at the moment. A research protocol has been launched in Guyana, where the virus is actively circulating. Is …

OraSure Technologies (NASDAQ:OSUR) Downgraded by Zacks Investment Research to Sell | 8/10/2020

… published on Friday morning, Zacks.com reports. According to Zacks, “OraSure Technologies, Inc. develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests , and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians …

Deep Learning Applications in the Biosciences | 8/10/2020

Oncology diagnostics and treatment is a rapidly changing field of medicine with new advancements announced almost daily. The number of diagnostic tests to select treatments based on a patient’s unique genetic mutations and tumor pathology characteristics has grown, as have the number of therapies available. These therapies can be matched to a patient’s likelihood to respond to treatment based on the results from diagnostic tests .Estimates indicate that Oncologists would have …

Biker rally, convention problems, school crowding: News from around our 50 states | 8/10/2020

… businesses. Arizona Phoenix: Public health experts and officials in the state say a decline in coronavirus testing last month has made it challenging to understand the virus and implement measures to limit its spread . Diagnostic tests for COVID-19 dropped from an average of more than 107,000 tests a week from late June to early July to about 51,400 tests the week of July 26. Over the course of just …

How to upscale COVID-19 test production at the pandemic’s peak | 8/10/2020

… domestic COVID-19 test manufacturing partner of numerous U.S. companies. × Expand Web Industries’ investment in a highly-automated lateral flow test manufacturing infrastructure has allowed it to ramp up production of COVID-19 rapid diagnostic tests . Young began by explaining that the company’s investment in lateral flow immunology in recent years positioned it to be able to quickly pivot to producing Coronavirus tests. Web is one of the few medical …

New Study Shows Screening Based on Self-Reported Ethnicity Fails to Identify Significant Percentage of Pregnancies Affected by Serious Genetic Conditions | Globe Newswire | 8/10/2020

… myriadwomenshealth.com/provider-foresight/ About Myriad Genetics Myriad 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 …

Can researchers find a way to run 10,000 COVID-19 tests at once? A team in Toronto is trying | 8/10/2020

… of students and staff on a daily basis could be valuable for catching cases and isolating them before they become a larger outbreak. High-throughput sequencing would dramatically boost the number of assays — actual diagnostic tests — Ontario could process on a given day. But “as we break one bottleneck, we’re trying to create solutions that solve the next bottleneck,” Wrana says. “This solves the kind of end-point bottleneck in …

IDEXX Laboratories to Host Virtual Investor Day | PR Newswire | 8/10/2020

… technology-based products and services. IDEXX products enhance the ability of veterinarians to provide advanced medical care, improve staff efficiency and build more economically successful practices. IDEXX is also a worldwide leader in providing diagnostic tests and information for livestock and poultry and tests for the quality and safety of water and milk and point-of-care and laboratory diagnostics for human medicine. Headquartered in Maine , IDEXX employs more than …

New Study Shows Screening Based on Self-Reported Ethnicity Fails to Identify Significant Percentage of Pregnancies Affected by Serious Genetic Conditions Nasdaq:MYGN | Globe Newswire | 8/10/2020

… myriadwomenshealth.com/provider-foresight/ About Myriad Genetics Myriad 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 …

Probe of DNA ‘repeats’ reveals new potential autism genes | 8/10/2020

… autism, suggesting new lines of inquiry for geneticists. “These genes are involved in autism, absolutely,” says study investigator Steve Scherer , professor of medicine at the University of Toronto in Canada. “Those [genes] will become diagnostic tests for the autism screening panel.” The researchers looked at areas of the genome with tandem repeats — stretches of 2 to 20 nucleotides, which are the ‘building blocks’ of DNA, that are repeated two or …

Helix Receives FDA Emergency Use Authorization for the HelixⓇ COVID-19 NGS Test, One of the First Sequencing-Based COVID-19 Tests | PR Newswire | 8/10/2020

… from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Additional information, including important …

Fapon 2nd COVID-19 Donation, 100 Million Anti-SARS-CoV-2 Fully Human RBD IgM & IgG QC Test Materials | PR Newswire | 8/10/2020

… donation was extraordinary. We alleviated the raw material shortage. PCR manufacturers over forty countries collaborated with us to develop and manufacture tests. We had supplied raw materials for the manufacturing of over 100 million diagnostic tests and ramped up the production capacity of 500%.” “This second donation offers high-demand QC materials that sit in the heart of reliable antibody tests. It will help to accelerate the internal QC process …

Google Alert - testing | 8/10/2020

testing As-it-happens update ⋅ August 10, 2020 NEWS How to do smarter coronavirus testing Axios Experts say the solution is smarter testing — which doesn’t require perfect accuracy. The big picture: Most coronavirus diagnostic tests right now are … Flag as irrelevant Number of Lewisburg penitentiary inmates testing positive for COVID-19 drops significantly pennlive.com Inmates who had tested positive were placed in isolation units in which corrections officers wear personal …

Dow Jones Now Up After Latest Trump Order | 8/10/2020

… deaths are now sitting at nearly 163,000. Former Microsoft Corp. (NASDAQ: MSFT ) executive and philanthropist Bill Gates said that it was “mind-blowing” how the U.S. government has failed to increase the number of diagnostic tests during the outbreak. “You’re paying billions of dollars in this very inequitable way to get the most worthless test results of any country in the world,” he told CNN . The nation’s top testing companies …

NIH ‘Shark Tank’ on track to produce quick, inexpensive COVID-19 tests by fall: Senators | MSN | 8/10/2020

… a $2.5 billion initiative in which the NIH, the Biomedical Advanced Research and Development Authority and private industry are working together overtime to develop new ways to produce tens of millions of COVID-19 diagnostic tests that are capable of providing quick, inexpensive results. A race to fast and cheap testing Today, the United States can conduct approximately 800,000 COVID-19 tests a day , but the current tests are complex …

Which test is best for COVID-19? | 8/10/2020

… tests is incomplete and the options for testing keep changing. But here’s what we know now about tests designed to diagnose a current infection, and those that show whether you previously had the virus. Diagnostic tests for current infection If you want to know if you are currently infected with the COVID-19 virus, there are two types of tests: molecular tests and antigen testing. Molecular tests (also called PCR …

President Signs a “Buy American for Essential Drugs and Medical Supplies” Executive Order | 8/10/2020

Against a backdrop of an ongoing, disruptive COVID-19 pandemic; natural security concerns about disruptions in the availability of drugs, personal protective equipment, and diagnostic tests —and the widely variable quality of these; acrimonious U.S.-China interactions; and the tumult of a presidential election year in a politically and economically polarized nation; the President signed an executive order directing the U.S. government to prioritize purchases of U.S. made drugs and …

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Co-Diagnostics, Inc. of Class Action Lawsuit and Upcoming Deadline – CODX | Benzinga | 8/10/2020

… mailing address, telephone number, and the number of shares purchased. [Click here for information about joining the class action] Co-Diagnostics, Inc., a molecular diagnostics company, intends to manufacture and sell reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules. It also intends to sell diagnostic equipment from other manufacturers as self-contained lab systems. The Complaint alleges that Defendants made continual …

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Co-Diagnostics, Inc. of Class Action Lawsuit and Upcoming Deadline – CODX | Globe Newswire | 8/10/2020

… mailing address, telephone number, and the number of shares purchased. [Click here for information about joining the class action] Co-Diagnostics, Inc., a molecular diagnostics company, intends to manufacture and sell reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules. It also intends to sell diagnostic equipment from other manufacturers as self-contained lab systems. The Complaint alleges that Defendants made continual …

Modern Cardiovascular Care Using Modern Technology | PR Newswire | 8/10/2020

… heartbeats. Dr. Agarwal says, “Why perform potentially risky invasive testing when a 1-2 seconds scan performed in the comfort of the office setting can give you the same information? We perform simple and Modern diagnostic tests to avoid the need for invasive testing. We focus on prevention, not waiting for a condition to develop.” Cardiovascular screening can be tailored for executives, women and men, diabetics, athletes, senior citizens, and others …

Food and Drug Administration

There are 10 coronavirus tests you can use from home. Here’s how they work and where to order one. | Business Insider | 8/11/2020

… the hundreds of tests out there for the novel coronavirus, just a handful have received emergency authorization from the US Food and Drug Administration to ship them to people’s homes. With at-home tests, people … at-home kits authorized , has run more than 4 million diagnostic tests since March, though that number includes those carried out at testing locations as well, a spokesperson told BI. The at-home tests are …

Department of Health and Human Services

State of Maryland Allows Point-of-Care Testing for COVID-19; Quidel Expands Training Program | Business Wire | 8/11/2020

… symptoms.” 1 Quidel Expands Training Program Separately, as part of its Nursing Home Program, and in collaboration with the U.S. Department of Health and Human Services (HHS), Quidel has expanded its Point-of-Care training … a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio …

COVID-19

10 healthcare execs on public health education amid the pandemic | Becker’s Hospital Review | 8/11/2020

… guidance. A banner across the top of every page of our Stanford Health Care public website directs users to a COVID-19 resource page . Additionally, the Stanford Medicine COVID-19 website provides news and guidance … for follow-up appointments, elective procedures and cancer screening and diagnostic tests. It is our responsibility to reassure people that if they have had growing concerns about their cancer risk or have symptoms of concern …

Biotech

Fapon 2nd COVID-19 Donation, 100 Million Anti-SARS-CoV-2 Fully Human RBD IgM & IgG QC Test Materials | PR Newswire | 8/10/2020

DONGGUAN, China , Aug. 10, Fapon Biotech Inc . (Fapon), a global leading IVD raw materials and one-stop solutions company, announces a new COVID-19 donation to meet the urgent demand for development and optimization of … supplied raw materials for the manufacturing of over 100 million diagnostic tests and ramped up the production capacity of 500%.” “This second donation offers high-demand QC materials that sit in the heart of reliable …

NIH

Helix Receives FDA Emergency Use Authorization for the HelixⓇ COVID-19 NGS Test, One of the First Sequencing-Based COVID-19 Tests | PR Newswire | 8/10/2020

… individual, and public health agencies, as necessary. Helix also announced on July 31, 2020 , that it was selected by the NIH’s Rapid Acceleration of Diagnostics (RADx) program to become one of the country’s COVID-19 … exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless …

Genomics

New Study Shows Screening Based on Self-Reported Ethnicity Fails to Identify Significant Percentage of Pregnancies Affected by Serious Genetic Conditions | Globe Newswire | 8/10/2020

… from the populations that the American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics and Genomics (ACMG) have indicated were at higher risk of the respective genetic disorders. “Due to … 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 …

American College of Obstetricians and Gynecologists

New Study Shows Screening Based on Self-Reported Ethnicity Fails to Identify Significant Percentage of Pregnancies Affected by Serious Genetic Conditions | Globe Newswire | 8/10/2020

… Further, for seven of the 16 diseases included in the guidelines, most carriers were not from the populations that the American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics and … 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 …

CDC

Holes in Data Remain Months Into Coronavirus Pandemic | U.S. News & World Report | 8/3/2020

… off some blunders she’s watched “with dismay”: This spring, the Centers for Disease Control and Prevention and some states pooled diagnostic tests with antibody tests, which identify whether someone has ever been infected with the … says. In mid-July, hospital capacity data moved from the CDC to the Department of Health and Human Services . As of Monday, Aug. 3, a public dashboard for the data had not been updated since …

Precision Medicine

Elevation Oncology Emerges from Stealth with $32.5M Series A to Develop Precision Medicines for Tumors Harboring Rare Genetic Driver Alterations | PR Newswire | 7/21/2020

GDPR Elevation Oncology Emerges from Stealth with $32.5M Series A to Develop Precision Medicines for Tumors Harboring Rare Genetic Driver Alterations - $32.5M Series A Financing Led by Aisling Capital, Vertex Ventures HC, Qiming Venture Partners … reduce the burden on patients by minimizing the number of diagnostic tests they may need and maximizing the treatment opportunities available to them, regardless of where they may live. Bringing clinical trials to patients using …

National Institutes of Health

3M pairs with MIT to develop a paper-based coronavirus diagnostic test | FierceBiotech | 7/15/2020

… the virus, providing a result in minutes without needing any laboratory equipment. The project is also being supported by the National Institutes of Health, through its competitive Rapid Acceleration of Diagnostics Tech program launched in … toward the goal of providing millions of new COVID-19 diagnostic tests by this fall …

American Medical Association

Myriad Announces New Studies Validating the Ability of Myriad’s riskScore® Test to Modify Breast Cancer Risk Prediction | Globe Newswire | 7/7/2020

… fold higher risk of breast cancer than an average risk patient. The second study published in the Journal of the American Medical Association Network Open demonstrates the ability of Myriad’s polygenic risk score to improve … 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 …

Center for Devices and Radiological Health

Pooled testing: What it is and how it can be used for the coronavirus - CNN | 7/6/2020

diagnostic tests on five samples. Fauci says task force ‘seriously considering’ new testing strategy “If the pooled sample is negative, it can be deduced that all patients were negative,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, wrote last month . “If the pooled sample comes back positive, then each sample needs to be tested individually to find out which was positive. “Because samples are pooled …

AMA

New CPT Code Expands COVID-19 Coding, Billing to Antigen Tests | RevCycle Intelligence | 6/29/2020

Reimbursement News New CPT Code Expands COVID-19 Coding, Billing to Antigen Tests The AMA’s new Category I CPT code will allow for COVID-19 coding and billing of antigen tests performed on patients suspected … CLIA Certificate of Waiver. Antigen tests notably differ from other diagnostic tests by determining whether a patient had COVID-19 in the past and antibodies against the novel coronavirus. They are another type of serology …

National Cancer Institute

Virality Diagnostics Antibody Test Wins FDA EUA | PR Newswire | 6/25/2020

… response to a SARS-CoV-2 infection, indicating past exposure to and infection by the novel coronavirus. Recent studies involving over 1,500 patients were conducted at multiple sites, including Yale University and the National Cancer Institute (NCI). These studies independently validated that Virality’s tests exhibit near perfect (98.8%) specificity for the novel coronavirus and extremely high sensitivity (94.9%) for patients tested at least 2-weeks from symptom onset. Studies also …

Medicare

NeuroMetrix Signs DPNCheck® Collaboration Agreement with Biomedix | Globe Newswire | 6/25/2020

WOBURN, Mass., June 25, 2020 (GLOBE NEWSWIRE) – NeuroMetrix, Inc. (Nasdaq: NURO) today reported that it has signed a collaboration agreement with Biomedix to comarket DPNCheck for peripheral neuropathy detection within Medicare Advantage and other value-based care markets. NeuroMetrix and Biomedix provide complementary diagnostic tests to physicians and health plans. Within these markets, healthcare providers are focused on detecting and documenting chronic health conditions to determine risk and prevent their …

Community Health

U.K. launches new national COVID-19 test validation project | FierceBiotech | 6/24/2020

… a number of universities, National Health Service (NHS) trusts and medical research groups, to evaluate the accuracy of new coronavirus diagnostic tests and how well they perform in different settings. The COVID-19 National DiagnOstic … the University of Oxford and deputy director of the NIHR’s Community Healthcare MedTech and IVD Co-operative. Sponsored by Clinical Ink White Paper: Keep Your GI Trials Moving During COVID-19 Clinical Ink’s intimate knowledge …

Clinical Research

Sera Prognostics Appoints Thomas J. Garite, M.D. as Vice President of Clinical Sciences - Business Wire | 6/24/2020

… Garite served as Director of Research and Education for Obstetrix, MedNax Medical Group where he directed the only ongoing Collaborative Clinical Research group composed of a consortium of private practices and university Maternal-Fetal medicine … of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera’s precision medicine PreTRM® test reports to a physician …

Health Research

U.K. launches new national COVID-19 test validation project | FierceBiotech | 6/24/2020

The U.K. government is launching a national research program, in collaboration with a number of universities, National Health Service (NHS) trusts and medical research groups, to evaluate the accuracy of new coronavirus diagnostic tests and how well they perform in different settings. The COVID-19 National DiagnOstic Research and Evaluation Platform, or CONDOR, will be funded by the National Institute for Health Research (NIHR), U.K. Research and Innovation, Asthma U.K …

Mental Health

Notice of Special Interest (NOSI): Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations | National Institutes of Health | 6/20/2020

… National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke … testing apply knowledge effective interventions increasing access uptake other viral diagnostic tests, vaccines, therapeutics underserved vulnerable populations e.g., human immunodeficiency virus HIV], hepatitis B C testing). Best practices this work be applicable the ongoing COVID …

Health Disparities

Notice of Special Interest (NOSI): Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations | National Institutes of Health | 6/20/2020

… Data Collection Center CDCC) U24 Clinical Trial Optional) Issued Office The Director, National Institutes Health OD) National Institute Minority Health Health Disparities NIMHD) National Institute Aging NIA) National Eye Institute NEI) National Heart, Lung, Blood … testing apply knowledge effective interventions increasing access uptake other viral diagnostic tests, vaccines, therapeutics underserved vulnerable populations e.g., human immunodeficiency virus HIV], hepatitis B C testing). Best practices this work be applicable the ongoing COVID …

NCCIH

Notice of Special Interest (NOSI): Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations | National Institutes of Health | 6/20/2020

… Health NIMH) National Institute Nursing Research NINR) National Library Medicine NLM) Fogarty International Center FIC) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS)National Cancer Institute NCI) applications this funding opportunity … testing apply knowledge effective interventions increasing access uptake other viral diagnostic tests, vaccines, therapeutics underserved vulnerable populations e.g., human immunodeficiency virus HIV], hepatitis B C testing). Best practices this work be applicable the ongoing COVID …

Brigham Young University

LDS apostle Jeffrey Holland home from hospital, will resume ‘normal activities’ | Salt Lake Tribune | 6/20/2020

Apostle Jeffrey R. Holland has been released from the hospital after undergoing diagnostic tests for an unknown illness, The Church of Jesus Christ of Latter-day Saints announced Friday. After a brief hospitalization “for observation … root in the faith Holland, a popular speaker and former Brigham Young University president, has been an apostle for nearly 26 years …

National Human Genome Research Institute

Notice of Special Interest (NOSI): Emergency Competitive Revisions for Community-Engaged Research on COVID-19 Testing among Underserved and/or Vulnerable Populations | National Institutes of Health | 6/20/2020

… Institute Minority Health Health Disparities NIMHD) National Institute Aging NIA) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy … testing apply knowledge effective interventions increasing access uptake other viral diagnostic tests, vaccines, therapeutics underserved vulnerable populations e.g., human immunodeficiency virus HIV], hepatitis B C testing). Best practices this work be applicable the ongoing COVID …

Clinical Diagnostics

Global Market Outlook for the Coronavirus Diagnostics Market to 2027 | PR Newswire | 6/19/2020

… the market growth.Based on type, the serology tests segment is going to experience lucrative growth during the forecast period as diagnostic tests are done using blood samples. Furthermore, these tests are helpful in determining patients … Company, bioMerieux, Bio-Rad Laboratories, GSK Biologicals, Hologic, Lonza, Ortho-Clinical Diagnostics, PerkinElmer, Qiagen and Roche Diagnostics. What the report offers: Market share assessments for the regional and country-level segments Strategic recommendations for the …

Medicaid

CMS Releases Medicare Payment Rates for COVID-19 Test CPT Codes | RevCycle Intelligence | 5/20/2020

Reimbursement News CMS Releases Medicare Payment Rates for COVID-19 Test CPT Codes Medicare payment rates for CPT codes 87635, 86769, and 86328 range from $42.13 to $51.31, CMS recently announced. Source: Centers for Medicare & Medicaid Services By May 20, 2020 - CMS recently revealed how much it will pay for new Current Procedural Terminology (CPT) codes developed by the American Medical Association (AMA) for COVID-19 diagnostic tests. On May …

Quidel

State of Maryland Allows Point-of-Care Testing for COVID-19; Quidel Expands Training Program | Business Wire | 8/11/2020

SAN DIEGO- Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that the State of Maryland has allowed point-of-care testing for … a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio …

LabCorp

There are 10 coronavirus tests you can use from home. Here’s how they work and where to order one. | Business Insider | 8/11/2020

… LabCorp, the first healthcare company to get the at-home kits authorized , has run more than 4 million diagnostic tests since March, though that number includes those carried out at testing locations as well, a spokesperson told BI. The at-home tests are similar in their sensitivity, or ability to detect coronavirus-positive samples, and specificity, or their ability to detect coronavirus-negative samples. To get tested, customers usually fill …

Myriad Genetics

New Study Shows Screening Based on Self-Reported Ethnicity Fails to Identify Significant Percentage of Pregnancies Affected by Serious Genetic Conditions | Globe Newswire | 8/10/2020

Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today a new study published in the peer-reviewed journal Genetics in Medicine demonstrates the limitations of ethnicity-based medical guidelines … 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 …

Quest Diagnostics

This tiny Texas company is running most of the drive-thru Covid-19 testing in the U.S. | STAT | 8/3/2020

… Curtis Compton/Atlanta Journal-Constitution via AP O n March 13, President Trump stood next to the CEOs of LabCorp, Quest Diagnostics, Walgreens, and Walmart in the Rose Garden, declared a national emergency, and promised … regulators to run high-complexity tests — like some Covid-19 diagnostic tests. And it had the machines that could run ThermoFisher’s TaqPath Covid-19 test — one of the first diagnostic tests the FDA authorized. Reditus …

Walmart Health

This tiny Texas company is running most of the drive-thru Covid-19 testing in the U.S. | STAT | 8/3/2020

… most of the drive-thru Covid-19 testing in the U.S. By Kate Sheridan @sheridan_kate August 3, 2020 Reprints Walmart pharmacist Shama Sarangi times a motorist doing a self swab to ensure a good … regulators to run high-complexity tests — like some Covid-19 diagnostic tests. And it had the machines that could run ThermoFisher’s TaqPath Covid-19 test — one of the first diagnostic tests the FDA authorized. Reditus …

Bio-Techne

Bio-Techne And Kantaro Biosciences To Launch A Quantitative Research Use Only COVID-19 Serology Test | PR Newswire | 8/3/2020

Bio-Techne And Kantaro Biosciences To Launch A Quantitative Research Use Only COVID-19 Serology Test News provided by Aug 03, 2020, 07:00 ET Share this article MINNEAPOLIS and NEW YORK , Aug. 3, 2020 /PRNewswire … partnership with RenalytixAI, is dedicated to ensuring that high-quality diagnostic tests for critical health challenges are accessible. The company provides rigorous, results-driven and reproducible diagnostics to advance the care and well-being of …

Exact Sciences

Exact Sciences to participate in August investor conference | PR Newswire | 8/3/2020

MADISON, Wis. Exact Sciences Corp. (Nasdaq: EXAS ) today announced that company management will participate in the following conference and invited investors to participate by webcast. Canaccord Genuity Annual Growth Conference Fireside Chat on Wednesday, August 12, 2020 , at 2:30 p.m. EDT The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com . About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests

Walgreens Healthcare

This tiny Texas company is running most of the drive-thru Covid-19 testing in the U.S. | STAT | 8/3/2020

… Atlanta Journal-Constitution via AP O n March 13, President Trump stood next to the CEOs of LabCorp, Quest Diagnostics, Walgreens, and Walmart in the Rose Garden, declared a national emergency, and promised the government … regulators to run high-complexity tests — like some Covid-19 diagnostic tests. And it had the machines that could run ThermoFisher’s TaqPath Covid-19 test — one of the first diagnostic tests the FDA authorized. Reditus …

Abbott Laboratories

INSIGHT-The U.S. has more COVID-19 testing than most. So why is it falling so short? | Nasdaq | 7/27/2020

Abbott Laboratories ABT.N – dominate this market. Their machines run on chemical kits and disposable plastic parts like sample plates and pipettes that only they sell, much like branded printer cartridges. “The vendors are in an impossible situation right now where they can’t say yes to everyone,” said Geoffrey Baird, who runs the medical laboratory at the University of Washington. U.S. labs now run about 800,000 diagnostic tests daily, according to …

Thermo Fisher

COVID-19 Rapid Test Kits Global Market Report 2020-30: COVID-19 Implications and Growth | PR Newswire | 7/21/2020

PRNewswire/ – Major players in the COVID-19 rapid test kits market are Thermo Fisher Scientific, Abbott Laboratories, BioMedomics, CTK Biotech, F. Hoffmann-La Roche AG, Cepheid Inc., Cellex Inc., Acumen Research Laboratories, and Biolidics, LabCorp.Read … kits manufactured by the entities that manufacture in-vitro rapid diagnostic tests in the medical equipment industry. The companies involved in manufacturing these rapid test kits are primarily engaged in designing, research and production of …

Thermo Fisher Scientific

COVID-19 Rapid Test Kits Global Market Report 2020-30: COVID-19 Implications and Growth | PR Newswire | 7/21/2020

PRNewswire/ – Major players in the COVID-19 rapid test kits market are Thermo Fisher Scientific, Abbott Laboratories, BioMedomics, CTK Biotech, F. Hoffmann-La Roche AG, Cepheid Inc., Cellex Inc., Acumen Research Laboratories, and Biolidics, LabCorp.Read … kits manufactured by the entities that manufacture in-vitro rapid diagnostic tests in the medical equipment industry. The companies involved in manufacturing these rapid test kits are primarily engaged in designing, research and production of …

Luminex

Luminex Receives FDA Emergency Use Authorization for COVID-19 Antibody Test | PR Newswire | 7/20/2020

AUSTIN, Texas , July 20, Luminex Corporation (NASDAQ: LMNX ) today announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the company’s xMAP ® SARS-CoV-2 Multi-Antigen IgG Assay … 2 Assay, which are rapid, RNA-based SARS-CoV-2 diagnostic tests that received EUAs in March and April of this year, respectively. The SARS-CoV-2 Multi-Antigen IgG Assay is the first of …

Genentech

Blueprint Medicines Announces Global Collaboration with Roche to Develop and Commercialize Pralsetinib for Patients with RET-Altered Cancers | Business & Finance | heraldchronicle.com | PR Newswire | 7/14/2020

… defined cancers, rare diseases and cancer immunotherapy, today announced that it has entered into a global collaboration with Roche and Genentech, a member of the Roche Group, to develop and commercialize pralsetinib, an investigational once … clinical trials; Blueprint Medicines’ ability to develop and commercialize companion diagnostic tests for its current and future drug candidates; and the success of Blueprint Medicines’ current and future collaborations or licensing arrangements. These and other …

Qiagen

FDA approves tests to screen for COVID-19, flu at same time | Becker’s Hospital Review | 7/8/2020

FDA approves tests to screen for COVID-19, flu at same time Maia Anderson - Print Email The FDA has granted emergency use approval to three diagnostic tests that can simultaneously test patients for COVID-19 and the flu. The latest combination test to receive emergency approval was developed by the CDC. The FDA has also granted emergency approval to combination tests from BioFire Diagnostics and Qiagen . The FDA said the …

Oncotype

Exact Sciences schedules annual meeting, second quarter 2020 earnings call | PR Newswire | 7/8/2020

… diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of Cologuard and Oncotype DX, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company’s website at www.exactsciences.com , follow Exact …

Biogen

Asuragen Announces CE Mark of AmplideX® SMA Plus Kit | Business & Finance | heraldchronicle.com | Business Wire | 7/7/2020

… the recent recommendations by the American College of Obstetrics and Gynecology and the availability of novel treatments including nusinersen (Spinraza ®, Biogen Idec) and onasemnogene abeparvovec-xioi (ZOLGENSMA ®, Novartis). “Our laboratory has many years of experience … laboratories across a patient’s lifespan with its best in class diagnostic tests. For more information, visit www.asuragen.com . View source version on businesswire.com : https://www.businesswire.com/news/home/20200707005261/en/ CONTACT: Lynne Hohlfeld SVP, Corporate Development and …

Chembio

Pomerantz Law Firm Announces the Filing of a Class Action against Chembio Diagnostics, Inc. and Certain Officers - CEMI | PR Newswire | 7/7/2020

Pomerantz Law Firm Announces the Filing of a Class Action against Chembio Diagnostics, Inc. and Certain Officers - CEMI News provided by Jul 06, 2020, 20:36 ET Share this article NEW YORK , July 6, 2020 /PRNewswire … its subsidiaries, develops, manufactures, and commercializes point-of-care (“POC”) diagnostic tests that are used to detect or diagnose diseases. Amidst the SARS-CoV-2, or COVID-19, pandemic, the Company focused on the development …

Regeneron Pharmaceuticals

Stephen Squinto, Ph.D., Named Vice Chairman of bioAffinity Technologies | Business Wire | 7/7/2020

diagnostic tests and therapeutics for the early detection and successful treatment of multiple cancers,” said Steve Girgenti, Chairman of the bioAffinity Board of Directors. “Dr. Squinto will continue to substantially contribute to our success as we accelerate the commercialization of our test for lung cancer, CyPath® Lung, and the advancement of our Targeted Gene Silencing therapeutic platforms.” Prior to his work at Alexion, Dr. Squinto held various positions at Regeneron …

Eli Lilly

OmniSeq Offers Differentiating Platform to Clinically Detect Rare Genetic Alterations to Identify Patients Eligible for New, Targeted Therapy for Lung and Thyroid Cancer | PR Newswire | 6/29/2020

… tumors of some patients with non-small cell lung cancer (NSCLC) and thyroid cancer. Those patients eligible for treatment with Eli Lilly and Company’s recently FDA-approved selective RET kinase inhibitor Retevmo™ (selpercatinib). Retevmo is … or clinical trials for each patient. OmniSeq’s suite of clinical diagnostic tests are offered exclusively by LabCorp to U.S.-based physicians through its Integrated Oncology specialty laboratory and to global biopharmaceutical customers through Covance, LabCorp’s …

Merck

BerGenBio Announces Positive Interim Clinical and Translational Data from Phase II Trial of Bemcentinib in Combination with Keytruda® in Checkpoint Inhibitor Refractory NSCLC Patients | PR Newswire | 6/25/2020

… and C are actively recruiting patients. The study is being sponsored by BerGenBio in collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, New Jersey , USA, who continue to supply Keytruda ® for use in … Phase I clinical testing. In parallel, BerGenBio is developing companion diagnostic tests to identify patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting a precision medicine …

Merck & Co

BerGenBio Announces Positive Interim Clinical and Translational Data from Phase II Trial of Bemcentinib in Combination with Keytruda® in Checkpoint Inhibitor Refractory NSCLC Patients | PR Newswire | 6/25/2020

… and C are actively recruiting patients. The study is being sponsored by BerGenBio in collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, New Jersey , USA, who continue to supply Keytruda ® for use in … Phase I clinical testing. In parallel, BerGenBio is developing companion diagnostic tests to identify patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting a precision medicine …

OraSure Technologies

Greater Than AIDS, With Support From Walgreens and OraSure Technologies, to Provide 10,000 Free In-Home HIV Tests to Community Partners | Business Wire | 6/25/2020

… Walgreens is providing a donation for the purchase of 9,000 OraQuick HIV test kits with an additional 1,000 donated by OraSure Technologies, Inc., the manufacturer of the rapid oral swab HIV self-tests. KFF, through … a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold …

GSK

Global Market Outlook for the Coronavirus Diagnostics Market to 2027 | PR Newswire | 6/19/2020

… the market growth.Based on type, the serology tests segment is going to experience lucrative growth during the forecast period as diagnostic tests are done using blood samples. Furthermore, these tests are helpful in determining patients … Beckman Coulter , Becton, Dickinson and Company, bioMerieux, Bio-Rad Laboratories, GSK Biologicals, Hologic, Lonza, Ortho-Clinical Diagnostics, PerkinElmer, Qiagen and Roche Diagnostics. What the report offers: Market share assessments for the regional and country-level …

Ortho Clinical Diagnostics

Global Market Outlook for the Coronavirus Diagnostics Market to 2027 | PR Newswire | 6/19/2020

… market growth. However, factors such as lack of skilled nursing staff is hampering the market growth.Based on type, the serology tests segment is going to experience lucrative growth during the forecast period as diagnostic tests are done using blood samples. Furthermore, these tests are helpful in determining patients with mild or no symptoms.By geography, North America is likely to have experience huge demand due to growing investments in R&D …

Roche Diagnostics

Global Market Outlook for the Coronavirus Diagnostics Market to 2027 | PR Newswire | 6/19/2020

… the market growth.Based on type, the serology tests segment is going to experience lucrative growth during the forecast period as diagnostic tests are done using blood samples. Furthermore, these tests are helpful in determining patients … GSK Biologicals, Hologic, Lonza, Ortho-Clinical Diagnostics, PerkinElmer, Qiagen and Roche Diagnostics. What the report offers: Market share assessments for the regional and country-level segments Strategic recommendations for the new entrants Covers Market data …

NCI

Virality Diagnostics Antibody Test Wins FDA EUA | PR Newswire | 6/25/2020

… SARS-CoV-2 infection, indicating past exposure to and infection by the novel coronavirus. Recent studies involving over 1,500 patients were conducted at multiple sites, including Yale University and the National Cancer Institute (NCI). These studies independently validated that Virality’s tests exhibit near perfect (98.8%) specificity for the novel coronavirus and extremely high sensitivity (94.9%) for patients tested at least 2-weeks from symptom onset. Studies also show that the …

William Blair

Exact Sciences to participate in June investor conferences | PR Newswire | 5/26/2020

William Blair 2020 Growth Stock ConferenceFireside Chat on Tuesday, June 9, 2020 , at 3:40 p.m. EDT The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com . About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of Cologuard and Oncotype DX, Exact …

Morgan Stanley

Edited Transcript of ABT earnings conference call or presentation 16-Apr-20 1:00pm GMT | 5/2/2020

… Laboratories - Executive VP of Finance & CFO Scott Michael Leinenweber Abbott Laboratories - VP of IR Conference Call Participants David Ryan Lewis Morgan Stanley, Research Division - MD Lawrence H. Biegelsen Wells Fargo Securities, LLC, Research Division - Senior … moment. As you know, we’ve quickly developed and launched 3 diagnostic tests for COVID-19: 2 for the laboratory setting and 1 for rapid point-of-care testing. At the same time, our teams in …

Merrill Lynch

Edited Transcript of ABT earnings conference call or presentation 16-Apr-20 1:00pm GMT | 5/2/2020

… Analyst Matthew Charles Taylor UBS Investment Bank, Research Division - Equity Research Analyst of Medical Supplies & Devices Robert Adam Hopkins BofA Merrill Lynch, Research Division - MD of Equity Research Robert Justin Marcus JP Morgan Chase & Co … moment. As you know, we’ve quickly developed and launched 3 diagnostic tests for COVID-19: 2 for the laboratory setting and 1 for rapid point-of-care testing. At the same time, our teams in …

JP Morgan

Edited Transcript of ABT earnings conference call or presentation 16-Apr-20 1:00pm GMT | Yahoo News | 5/2/2020

… Analyst of Medical Supplies & Devices Robert Adam Hopkins BofA Merrill Lynch, Research Division - MD of Equity Research Robert Justin Marcus JP Morgan Chase & Co, Research Division - Analyst Vijay Muniyappa Kumar Evercore ISI Institutional Equities, Research … moment. As you know, we’ve quickly developed and launched 3 diagnostic tests for COVID-19: 2 for the laboratory setting and 1 for rapid point-of-care testing. At the same time, our teams in …

Omni Capital

Age-related macular degeneration treatment at Spire Liverpool Hospital | Spire Healthcare | 12/3/2019

… of what’s included and excluded in your fixed price when paying for yourself. Finance options are available through our partner Omni Capital Retail Finance Ltd, 10 Norwich Street, London, EC4A 1BD. Who will do it … have. We will also discuss with you whether any further diagnostic tests, such as scans or blood tests, are needed. Any additional costs will be discussed before further tests are carried out. Preparing for your …

Cambridge Innovation Capital

Cambridge Innovation Capital has attracted £1 billion of investment into Cambridge companies | BioSpace | 12/3/2019

Cambridge Innovation Capital has attracted £1 billion of investment into Cambridge companies Published: Dec 02, 2019 Since its foundation Cambridge Innovation Capital has attracted £1 billion of investment into Cambridge companies, highlighting its dominant position … developing a portfolio of instrument-free, point-of-care molecular diagnostic tests, a pioneering new class of diagnostic product. Sense Biodetection plans to invest the new funds in the development and manufacture of a range …

Goldman Sachs

Global RNAi Therapeutics Market 2019-2030: Focus on siRNA, miRNA, shRNA and DNA | PR Newswire | 11/27/2019

… miRNA Biomarkers in Cardiovascular Diseases 15.5.1. Key Indications 15.5.1.1. Myocardial Infarction (MI) 15.5.1.2. Coronary Artery Disease (CAD) 15.6. miRNA Based Diagnostic Tests 16. SERVICE PROVIDERS FOR RNAi THERAPEUTICS 16.1. Chapter Overview 16.2. List of Service … Pharmaceuticals Sanofi Genzyme / Genzyme Genomics England GlaxoSmithKline (GSK) Glycostem Therapeutics Goldman Sachs Gradalis Gritstone Oncology Guang’anmen Hospital of China Academy of Chinese Medical Sciences Harvard University Helmholtz Zentrum Mnchen Hercules Capital Histalim HuaKong Equity Investment …

Citigroup

Analysts’ Downgrades for November, 27th (AAXN, BECN, BGAOY, BPRMF, CMPGY, DLTR, HVRRY, LOMA, NSRGY, NTGN) | 11/27/2019

… and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as … others. “ Pennon Group (OTCMKTS:PEGRF) was downgraded by analysts at Citigroup Inc from a buy rating to a neutral rating. PARINGA RESOURC/S (NASDAQ:PNRL) was downgraded by analysts at Zacks Investment Research from a …

F-Prime Capital

Global RNAi Therapeutics Market 2019-2030: Focus on siRNA, miRNA, shRNA and DNA | PR Newswire | 11/27/2019

… miRNA Biomarkers in Cardiovascular Diseases 15.5.1. Key Indications 15.5.1.1. Myocardial Infarction (MI) 15.5.1.2. Coronary Artery Disease (CAD) 15.6. miRNA Based Diagnostic Tests 16. SERVICE PROVIDERS FOR RNAi THERAPEUTICS 16.1. Chapter Overview 16.2. List of Service … Eurofins Genomics Eurogentec Exiqon Fidelity Biosciences FOCUS Media Jiangnanchun Foundation F-Prime Capital GeneCopoeia GeneCust GeneDesign GENEL Genentech GenePharma Genesis Pharmaceuticals Sanofi Genzyme / Genzyme Genomics England GlaxoSmithKline (GSK) Glycostem Therapeutics Goldman Sachs Gradalis Gritstone Oncology …

Domain Associates

Global RNAi Therapeutics Market 2019-2030: Focus on siRNA, miRNA, shRNA and DNA | PR Newswire | 11/27/2019

… miRNA Biomarkers in Cardiovascular Diseases 15.5.1. Key Indications 15.5.1.1. Myocardial Infarction (MI) 15.5.1.2. Coronary Artery Disease (CAD) 15.6. miRNA Based Diagnostic Tests 16. SERVICE PROVIDERS FOR RNAi THERAPEUTICS 16.1. Chapter Overview 16.2. List of Service … Creative Biogene CureDuchenne Dana-Farber Cancer Institute Dharmacon Dicerna Pharmaceuticals Domain Associates EcoR1 Capital Eli Lilly Eurofins Genomics Eurogentec Exiqon Fidelity Biosciences FOCUS Media Jiangnanchun Foundation F-Prime Capital GeneCopoeia GeneCust GeneDesign GENEL Genentech GenePharma …

HealthCare Ventures

Global RNAi Therapeutics Market 2019-2030: Focus on siRNA, miRNA, shRNA and DNA | PR Newswire | 11/27/2019

… 15.4.5.3. Lung Cancer 15.4.5.4. Colorectal Cancer 15.4.5.5. Gastric Cancer 15.4.5.6. Hematological Cancer 15.5. miRNA Biomarkers in Cardiovascular Diseases 15.5.1. Key Indications 15.5.1.1. Myocardial Infarction (MI) 15.5.1.2. Coronary Artery Disease (CAD) 15.6. miRNA Based Diagnostic Tests 16. SERVICE PROVIDERS FOR RNAi THERAPEUTICS 16.1. Chapter Overview 16.2. List of Service Providers 16.2.1. Analysis by Type of Service Provider 16.2.2. Analysis by Location of Service Provider 16.2.3. Analysis by Type of RNAi Molecule …

Next Coast Ventures

Austin-based Next Coast Ventures just closed its second fund with $130 million | TechCrunch | 11/22/2019

… Partners , Unusual Ventures , Northzone , Kindred Ventures , EQT Ventures , Inspired Capital and Norwest Venture Partners . Newly in the same company is Next Coast Ventures, a firm that just closed on $130 million in fresh capital commitments … include Everlywell, a company that sells tens of in-home diagnostic tests and that closed on $50 million in funding earlier this year, and AlertMedia, a cloud-based mass notification system that aims to streamline …

Norwest Venture Partners

Austin-based Next Coast Ventures just closed its second fund with $130 million | TechCrunch | 11/22/2019

… include Boldstart Ventures , Drive Capital , .406 Ventures , CAVU Venture Partners , Unusual Ventures , Northzone , Kindred Ventures , EQT Ventures , Inspired Capital and Norwest Venture Partners . Newly in the same company is Next Coast Ventures, a firm that … include Everlywell, a company that sells tens of in-home diagnostic tests and that closed on $50 million in funding earlier this year, and AlertMedia, a cloud-based mass notification system that aims to streamline …

Jefferies Financial Group

Investment Analysts’ Recent Ratings Updates for EXACT Sciences (EXAS) | 11/20/2019

… They now have a “buy” rating on the stock. 10/30/2019 – EXACT Sciences had its price target lowered by analysts at Jefferies Financial Group Inc from $138.00 to $120.00. They now have a “buy” rating on … detected early. Despite the availability of colorectal cancer screening and diagnostic tests for more than twenty years, the rate of early detection of colorectal cancer remains low, and deaths from colorectal cancer remain high. EXACT …

Piper Jaffray

Quidel to Present at Upcoming Conferences | Business Wire | 11/15/2019

… virology assays and molecular diagnostic systems, announced today that it will present at the following upcoming conferences: 31 st Annual Piper Jaffray Healthcare Conference to be held at the Lotte New York Palace hotel in … a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio …

Maxim Group

Navidea Biopharmaceuticals’ (NAVB) CEO Jed Latkin on Q3 2019 Results - Earnings Call Transcript | Seeking Alpha | 11/9/2019

… Chief Executive Officer Mike Rosol – Chief Medical Officer Erika Gibs – Director of Finance and Administration Conference Call Participants Jason McCarthy – Maxim Group Rick Drew – Private Investor Jed Latkin Good afternoon, and welcome, everyone, to Navidea’s … relate to the effectiveness of the company’s bodily fluid-based diagnostic tests as well as the company’s ability to develop and successfully commercialize such test platforms for early detection of cancer and the diagnosis and …

Founders Fund

Scanwell Health launches smartphone tests for UTIs in partnership with Lemonaid Health | TechCrunch | 11/6/2019

… move along its journey are a clutch of well-positioned investors, including the Y Combinator accelerator and institutional investors like Founders Fund, Mayfield, DCM, Version One and Joe Montana’s Liquid 2 Ventures fund. “This funding … is only the beginning. We have a number of additional diagnostic tests in the pipeline that have the potential to change the way we diagnose and treat infections and monitor chronic diseases. We look forward …

Liquid 2 Ventures

Scanwell Health launches smartphone tests for UTIs in partnership with Lemonaid Health | TechCrunch | 11/6/2019

Liquid 2 Ventures fund. “This funding from an incredible group of investors, together with the national launch of our test and app, are exciting milestones that will allow us to realize our vision of making reliable, convenient at-home testing available to millions of people,” said Chen, in a statement. “Our partnership with Lemonaid is only the beginning. We have a number of additional diagnostic tests in the pipeline that …

Zacks Equity Research

Myriad Genetics (MYGN) Lags Q1 Earnings and Revenue Estimates | Zacks | 11/5/2019

You follow Analyst Blog - edit You follow Zacks Equity Research - edit What would you like to follow? Zacks Equity Research Cancel Read More Hide Full Article Myriad Genetics, Inc . ( MYGN - Free Report ) reported adjusted earnings … Consensus Estimate by 8.2%. Quarter in Detail Segment-wise, Molecular diagnostic tests recorded total revenues of $172 million, down 9% year over year. Within this segment, Hereditary Cancer testing revenues were down 10% year over …

Y Combinator

Scanwell announces $3.5M seed funding for home UTI testing, launches nationally through Lemonaid Health | MobiHealthNews | 11/5/2019

The round included Founders Fund, Mayfield, DCM, Version One, Y Combinator and Liquid 2 Ventures. November 05, 2019 Share Scanwell Health, maker of a smartphone-based platform for home urinary tract infection screening, has raised … said in a statement. “We have a number of additional diagnostic tests in the pipeline that have the potential to change the way we diagnose and treat infections and monitor chronic diseases. We look forward …

Indiana Economic Development Corporation

MiraVista Diagnostics Expanding Laboratory, Clinical Capabilities, Increasing Diagnostic Offerings | The Wapakoneta Daily News | 11/4/2019

diagnostic tests annually, has invested more than $5.3 million to expand and equip its headquarters, doubling the size of its facility. Last year MiraVista received a grant from the Indiana Economic Development Corporation (IEDC) to support their laboratory expansion and workforce training. MiraVista plans to continue expanding operations and create new jobs through the end of 2020. “We’re incredibly proud of our growth in the past year. We’ve had a …

Bill & Melinda Gates Foundation

Gates Foundation backs ‘instrument-free’ molecular diagnostic tests through Sherlock, Mologic tie-up | FierceBiotech | 10/30/2019

… in the home, as well as in low-resource settings—and the two companies are enlisting the help of the Bill & Melinda Gates Foundation to do it. Combining Sherlock’s work in detecting specific pieces of … companies’ core technologies, we believe we can create extremely sensitive diagnostic tests that produce results with unprecedented speed, without requiring instrumentation, thermal amplification or electricity,” Mologic co-founder and CEO Mark Davis said in a …

Cultivation Capital

Geneoscopy Raises $6.9 Million to Advance Preventive Screening Test for Colorectal Cancer and Advanced Adenomas | Business Wire | 10/2/2019

diagnostic tests for gastrointestinal (GI) health, today announced a successful and oversubscribed $6.9 million Series A financing. The Company plans to use the proceeds from this financing to advance its colorectal cancer (CRC) screening test, which quantifies eukaryotic RNA isolated from epithelial cells in stool to detect CRC and advanced adenomas. This financing was led by Cultivation Capital and NT Investments. Lightchain Capital LLC, the family office of Scottrade founder …

Mount Sinai Health System

Bio-Techne And Kantaro Biosciences To Launch A Quantitative Research Use Only COVID-19 Serology Test | PR Newswire | 8/3/2020

… 07:00 ET Share this article MINNEAPOLIS and NEW YORK , Aug. 3, 2020 /PRNewswire/ – Bio-Techne Corporation (NASDAQ: TECH ) and the Mount Sinai Health System in New York , through its commercial affiliate Kantaro Biosciences LLC (Kantaro … partnership with RenalytixAI, is dedicated to ensuring that high-quality diagnostic tests for critical health challenges are accessible. The company provides rigorous, results-driven and reproducible diagnostics to advance the care and well-being of …

Medical Center

The U.S. Has More COVID-19 Testing Than Most. So Why Is It Falling So Short? | U.S. News & World Report | 7/27/2020

… 27, 2020 By Reuters , Wire Service Content July 27, 2020, at 7:05 a.m. FILE PHOTO: A lab at Methodist Dallas Medical Center prepares viral transport media for samples before collecting samples for coronavirus disease (COVID … the University of Washington. U.S. labs now run about 800,000 diagnostic tests daily, according to the COVID Tracking Project. But the United States needs 6-10 million tests per day, by various estimates. Congress has earmarked …

Massachusetts General Hospital

Published National Findings in Lyme Disease Testing to Be Discussed on July 30 Webinar Hosted by Quidel Corporation | Business Wire | 7/21/2020

… for Disease Control and Prevention. Dr. Lee-Lewandrowski is a member of the faculty of the department of pathology at Massachusetts General Hospital in Boston where she also serves as a clinical laboratory scientist in … a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel, visit quidel.com . View …

Harvard Medical School

Published National Findings in Lyme Disease Testing to Be Discussed on July 30 Webinar Hosted by Quidel Corporation | Business Wire | 7/21/2020

… Boston where she also serves as a clinical laboratory scientist in chemistry. She is also assistant professor of pathology at Harvard Medical School. A member of the American Association for Clinical Chemistry, Dr. Lee-Lewandrowski … a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel, visit quidel.com . View …

Mayo Clinic

Cernostics Announces Blinded, Independent Validation of TissueCypher(R) Performance for Predicting Risk of Progression to Esophageal Cancer in Patients With Non-Dysplastic BE | PR Newswire | 6/25/2020

… for NDBE, based on large population studies. In an editorial accompanying the published results, Prasad G. Iyer , MD, MSc, at Mayo Clinic in Rochester, Minnesota , describes TissueCypher as the potential “Holy Grail” for Barrett’s Esophagus … Cernostics Cernostics, a leader in tissue-based diagnostic testing, provides diagnostic tests with deeper tissue insights, better patient outcomes, and lower cost of care. Cernostics’ mission is to quantify the tissue system complexity, providing physicians …

Cleveland Clinic

As states reopen, COVID-19 testing remains far from where it should be | PBS | 6/18/2020

… there’s “increasing and incredible demand for more and more testing,” said Dr. Gary Procop, who directs laboratory work at the Cleveland Clinic in Ohio. Hospitals need fast and accurate tests to know if an incoming … of tests have different functions, drawbacks and levels of accuracy. Diagnostic tests rely on polymerase chain reactions to identify a virus’ ribonucleaic acids, or RNA, and determine if it is active in a person. This …

Cleveland Clinic, Cleveland OH

As states reopen, COVID-19 testing remains far from where it should be | PBS | 6/18/2020

… there’s “increasing and incredible demand for more and more testing,” said Dr. Gary Procop, who directs laboratory work at the Cleveland Clinic in Ohio. Hospitals need fast and accurate tests to know if an incoming … of tests have different functions, drawbacks and levels of accuracy. Diagnostic tests rely on polymerase chain reactions to identify a virus’ ribonucleaic acids, or RNA, and determine if it is active in a person. This …

Vanderbilt University Medical Center

Fears of coronavirus second wave prompt flu push at U.S. pharmacies, drugmakers | Yahoo News | 5/26/2020

… double-barreled assault this fall and winter with flu and COVID. Flu is the one you can do something about,“ Vanderbilt University Medical Center infectious disease expert Dr. William Schaffner said. Drugmakers last year produced … need to develop drive-up clinics – popular with COVID-19 diagnostic tests – for flu vaccines, said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Disease. “My goal is that every …

University Medical Center

Some have tested positive for COVID-19 after recovering. What does that mean? | Yahoo News | 5/19/2020

… following negative tests may be a quirk related to the type of test that was used. Nearly all of the diagnostic tests for COVID-19 in the U.S. look for snippets of the virus’ RNA … said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center in Nashville. A study from South Korea bolsters that idea. Researchers at the Korean Centers for Disease Control and Prevention analyzed data …

Banner Health

100 hospitals and health systems with great orthopedic programs | 2019 | Becker’s Hospital Review | 12/4/2019

… orthopedic programs in the nation by U.S. News & World Report and supports research and clinical trials for new orthopedic treatments. Banner Health (Phoenix). Banner Health’s orthopedic program spans hospitals in Phoenix, Tucson and Northern Colorado … causes of chronic hand, shoulder and elbow pain using advanced diagnostic tests. Through the hospital’s Wake Forest Innovations division, orthopedic surgeons are pioneering new treatments with funding from the Department of Defense, the Orthopaedic Research …

Ascension

100 hospitals and health systems with great orthopedic programs | 2019 | Becker’s Hospital Review | 12/4/2019

… also cover athletic events throughout the state. Orthopaedic Hospital of Wisconsin (Glendale). Orthopaedic Hospital of Wisconsin is a member of Ascension Wisconsin and serves patients from across the state. Since being established in 2001 as … causes of chronic hand, shoulder and elbow pain using advanced diagnostic tests. Through the hospital’s Wake Forest Innovations division, orthopedic surgeons are pioneering new treatments with funding from the Department of Defense, the Orthopaedic Research …

UT Southwestern Medical Center

Global RNAi Therapeutics Market 2019-2030: Focus on siRNA, miRNA, shRNA and DNA | PR Newswire | 11/27/2019

… miRNA Biomarkers in Cardiovascular Diseases 15.5.1. Key Indications 15.5.1.1. Myocardial Infarction (MI) 15.5.1.2. Coronary Artery Disease (CAD) 15.6. miRNA Based Diagnostic Tests 16. SERVICE PROVIDERS FOR RNAi THERAPEUTICS 16.1. Chapter Overview 16.2. List of Service … Pennsylvania University of Texas University of Virginia School of Medicine UT Southwestern Medical Center Value Measured Investment Vector Biolabs Vir Biotechnology ViThera Laboratories Weston Biotechnology WTT Investment YuYu Pharma Yuexiu New Industrial Investment Yuhan ZonMw …

University Hospital

Renal Cancer Research by Sengenics and the University of Leeds Awarded Early Detection Primer Grant Funding from Cancer Research UK | PRWeb | 11/26/2019

… Banks, co-leads of the Clinical and Biomedical Proteomics group at the University of Leeds based on the St James’s University Hospital campus and interfaced with the Leeds Teaching Hospitals NHS Trust said, “Autoantibody production … Sengenics’ unique protein array technology will ultimately lead to improved diagnostic tests for RCC disease.” About Sengenics Sengenics is a functional proteomics company that leverages its patented KREX technology for production of full-length, correctly …

The Ohio State University Wexner Medical Center

3 STDs have skyrocketed in the U.S., new CDC report says — here’s what you need to know | 11/23/2019

… Control and Prevention (CDC). Jose Bazan , an associate professor of clinical internal medicine in the Division of Infectious Diseases at The Ohio State University Wexner Medical Center, tells Yahoo Lifestyle that the spike in STD … point to advances in STD prevention, such as better chlamydia diagnostic tests and more screening, contributing to increases in detection and treatment of chlamydial infections,” Gail Bolan , MD, director of the division of STD Prevention …

IHA Health

(USA-MI-Pontiac) Medical Assistant (MA) | 11/22/2019

IHA Health Services Corp Medical Assistant (MA) in Pontiac , Michigan Job Details: POSITION DESCRIPTION: Assists in the examination and treatment of patients by tracking patient information, documenting the medical record, assisting with in office procedures … electronic medical record per state, local and professional guidelines. Performs diagnostic tests as directed by healthcare provider. May operate equipment to administer routine diagnostic tests. Credentialed MAs will perform TB testing. Tracks and informs patient …

Kaiser Permanente

NP II/ PA II - Surgical Urology - USA-CA-Riverside | 11/21/2019

… Procedures and Process Protocols for Ambulatory and Hospital-Based Practice. They perform complete physical examinations, including ordering, interpreting and evaluating diagnostic tests and examinations. Assume on-going responsibility for each patient from discovery of the … or surgical conditions.Consistently supports compliance and the Principles of Responsibility (Kaiser Permanente’s Code of Conduct) by maintaining the privacy and confidentiality of information, protecting the assets of the organization, acting with ethics and integrity, reporting …

Emory Healthcare

(USA-GA-Atlanta) EMT, Emergency Department, 7p-7:30a | 11/19/2019

Emory Healthcare/Emory University EMT, Emergency Department, 7p-7:30a in Atlanta , Georgia Description JOB DESCRIPTION: Ensures general patient satisfaction, including but not limited to providing blankets, food, and updates on treatment status. Focuses education of … Takes vital signs. Performs accuchecks. Transports patients to and from diagnostic tests as well as to floor beds. Assists in acute and code situations. Is familiar with all aspects of emergency situations and works with …

UChicago Medicine

Muni Credit News Week of November 18, 2019 | 11/19/2019

… goal is to use Google’s artificial intelligence tools to recommend changes to a patient’s care, such as different treatment plans, diagnostic tests or additional physicians, as well as to flag unexpected deviations in the patient’s … system had not properly de-identified patient information. Google and UChicago Medicine have maintained that they followed regulations, including HIPAA. It is difficult to deal with the single mindedness of the tech entities in terms …

Lenox Hill Hospital

Country star Chely Wright, 48, mistakes severe stroke for migraine - Yahoo7 Be | Yahoo News | 11/7/2019

… one where symptoms mirrored those of a severe migraine. “Exactly one year ago today, I went to the ER at Lenox Hill Hospital because I was on Day 3 of a migraine, which isn’t uncommon … be “troubled” by her “headache” symptoms. “After a series of diagnostic tests, I was informed that I’d had a stroke. A stroke. I’d just turned 48,” she wrote. Despite her surprise, Chely admitted that she …

NYU Langone Health

First Molecular Test in the U.S. to Better Detect Brain Tumors Now Available to Patients | Markets Insider | Business Insider | 11/6/2019

NEW YORK , Nov. 6, 2019 /PRNewswire/ – NYU Langone Health and its Perlmutter Cancer Center have launched clinical whole genome DNA methylation profiling for patients with brain tumors . This leading-edge molecular assay utilizes DNA epigenetic … multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct. Three federal agencies are responsible for CLIA: The Food and Drug Administration, CMS, and the Centers for Disease Control and Prevention …

Perlmutter Cancer Center

First Molecular Test in the U.S. to Better Detect Brain Tumors Now Available to Patients | Markets Insider | Business Insider | 11/6/2019

NEW YORK , Nov. 6, 2019 /PRNewswire/ – NYU Langone Health and its Perlmutter Cancer Center have launched clinical whole genome DNA methylation profiling for patients with brain tumors . This leading-edge molecular assay utilizes DNA epigenetic … multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct. Three federal agencies are responsible for CLIA: The Food and Drug Administration, CMS, and the Centers for Disease Control and Prevention …

HCA

Biodesix Announces First System-Wide Integration of Nodify XL2 Testing for Lung Nodule Management | Business & Finance | heraldchronicle.com | Business Wire | 11/4/2019

… the leader in lung cancer diagnostics, today announced that Tri-Star Health in Nashville, TN, the region’s largest, most comprehensive healthcare provider, is the first hospital system in the U.S. to adopt the recently launched … through treatment guidance in late stage cancer. The company develops diagnostic tests addressing important clinical questions by combining simple blood draws and multi-omics through the power of artificial intelligence. Biodesix is the first company …

Northwell Health

(USA-NY-Syosset) Nursing Assistant II (SY) | 10/29/2019

Northwell Health Nursing Assistant II (SY) in Syosset , New York Req Number 002POY Job Description In the role of Nursing Assistant II, you will perform selected diagnostic tests and prescribed treatments. You will also provide patients with assistance in performing the activities of daily living and assist the health care team in ensuring patients safety. Job Responsibilities Include: Provides patients with assistance in performing the activities of daily living. Provides …

Rush University Medical Center, Chicago IL

Dr. Mark H. Pollack named Chief Medical Officer for Myriad Neuroscience | Globe Newswire | 10/21/2019

… experience in clinical psychiatry and neuroscience. Most recently, he served as professor and chair of the Department of Psychiatry at Rush University Medical Center in Chicago. Prior to Rush, Dr. Pollack was a professor of … 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 …

Rush University Medical Center

Dr. Mark H. Pollack named Chief Medical Officer for Myriad Neuroscience | Globe Newswire | 10/21/2019

… experience in clinical psychiatry and neuroscience. Most recently, he served as professor and chair of the Department of Psychiatry at Rush University Medical Center in Chicago. Prior to Rush, Dr. Pollack was a professor of … 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 …

Aetna

Exact Sciences Corp (EXAS) Q3 2019 Earnings Call Transcript | The Motley Fool | 10/30/2019

… in 2019: one, powering our partnership with Pfizer, two, enhancing Cologuard; and three, advancing our pipeline of blood-based cancer diagnostic tests.Starting with our first priority, we’re confident that we can capture at least 40 … following the American Cancer Society guidelines update last year, including Aetna, CareFirst and Blue Shield of California. This is encouraging progress and our team is engaging with other payers educating their sales force and developing …

What’s in the Offing for LabCorp’s (LH) Earnings in Q3? | MSN | 10/21/2019

… Aetna, placing LabCorp in-network under all major national plans. Ever since, the company has been registering consistent organic growth on the back of these partnerships. The upside is likely to get reflected in the company’s third-quarter results. Second, the company is expected to have advanced its companion diagnostics and oncology capabilities in the third quarter, backed by the introduction of two new companion diagnostic tests, namely PIK3CA for …

UnitedHealthcare

What’s in the Offing for LabCorp’s (LH) Earnings in Q3? | MSN | 10/21/2019

UnitedHealthcare and Aetna, placing LabCorp in-network under all major national plans. Ever since, the company has been registering consistent organic growth on the back of these partnerships. The upside is likely to get reflected in the company’s third-quarter results. Second, the company is expected to have advanced its companion diagnostics and oncology capabilities in the third quarter, backed by the introduction of two new companion diagnostic tests, namely …

What’s in the Offing for LabCorp’s (LH) Earnings in Q3? - October 21, 2019 - Zacks.com | 10/21/2019

UnitedHealthcare and Aetna, placing LabCorp in-network under all major national plans. Ever since, the company has been registering consistent organic growth on the back of these partnerships. The upside is likely to get reflected in the company’s third-quarter results. Second, the company is expected to have advanced its companion diagnostics and oncology capabilities in the third quarter, backed by the introduction of two new companion diagnostic tests, namely …

Health Net

Philadelphia diagnostics disruptor teams up with Lehigh Valley firm for clinical trial | The Business Journals | 8/22/2019

Senior Reporter, Philadelphia Business Journal Aug 22, 2019, 10:46am EDT A Philadelphia biotechnology company that is out to transform how patients get diagnostic tests has formed a partnership with a Lehigh Valley-based laboratory services provider. Under the collaboration, Group K Diagnostics and Health Network Laboratories of Allentown will work together to make Group K’s technology accessible to HNL patients, Specifically, patients seeking liver-function testing have the opportunity to …

Group K Diagnostics and Health Network Laboratories Announce the Commencement of a Clinical Trial | PR Newswire | 8/20/2019

PHILADELPHIA , Aug. 20, 2019 /PRNewswire/ – Group K Diagnostics (GKD), a biotechnology innovator aiming to transform the diagnostic process, and Health Network Laboratories (HNL), a leader in high quality, innovative laboratory medicine services, announce a collaboration … This latest technology advancement may transform how and where certain diagnostic tests are performed.” To participate in the free clinical trial, patients 18 years or older can sign up at two of HNL’s Patient Service …

Anthony Fauci

10 healthcare execs on public health education amid the pandemic | Becker’s Hospital Review | 8/11/2020

… at our hospitals, as well as on clinical care and research. Stanford Medicine Dean Lloyd Minor’s “fireside chat” with Dr. Anthony Fauci brought this conversation live to virtual viewers nationally, and our experts make themselves … for follow-up appointments, elective procedures and cancer screening and diagnostic tests. It is our responsibility to reassure people that if they have had growing concerns about their cancer risk or have symptoms of concern …

Jay Mazelsky

IDEXX Laboratories to Host Virtual Investor Day | PR Newswire | 8/10/2020

… followed by a question and answer session. Participating in the event will be members of the IDEXX senior leadership team: Jay Mazelsky , President and Chief Executive Officer Brian McKeon , Executive Vice President and Chief Financial … successful practices. IDEXX is also a worldwide leader in providing diagnostic tests and information for livestock and poultry and tests for the quality and safety of water and milk and point-of-care and laboratory …

Rick Bright

Helix Receives FDA Emergency Use Authorization for the HelixⓇ COVID-19 NGS Test, One of the First Sequencing-Based COVID-19 Tests | PR Newswire | 8/10/2020

… generation sequencing technology to conduct 100,000 tests per day in the same laboratory is a logistical and scientific breakthrough,” said Rick Bright , Ph.D., Senior Advisor to the NIH Director. “This sets the country on an … exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless …

Dwight Egan

Co-Diagnostics, Inc. Technology to be Used in FDA-Authorized Self-Collected COVID-19 Saliva Test | PR Newswire | 8/3/2020

… 2020 /PRNewswire/ – Co-Diagnostics, Inc. (Nasdaq: CODX ) , a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that its partner, Clinical Reference Laboratory (CRL) has received FDA Emergency … and specificity of our CoPrimer primer and probe technology,” remarked Dwight Egan , CEO of Co-Diagnostics. “Co-Diagnostics is pleased to be a part of a testing initiative with so much potential to help people …

Alex Azar

NIH picks seven COVID-19 diagnostic tests in ‘Shark Tank’ competition, unlocking $248.7M in scale-up funding | FierceBiotech | 8/3/2020

… will help deliver faster results from labs and more and more test results within minutes at the point of care, which is especially important for settings like schools and nursing homes,” HHS Secretary Alex Azar said in a statement . RELATED: NIH begins taking pitches for its $1.5B COVID-19 diagnostics competition Of the seven tests, three focus on providing in-person results in under a half-hour: Mesa Biotech’s hand …

Jeremy Olson

Minnesota reports 622 new COVID-19 cases, no more from rodeo yet | Star Tribune | 8/3/2020

Coronavirus Minnesota reports 622 new COVID-19 cases, no more from rodeo so far By Jeremy Olson , Star Tribune August 03, 2020 - 4:58 PM See more of the story Diagnostic tests have found another 622 infections with the coronavirus that causes COVID-19 in 57 Minnesota counties. The Minnesota Department of Health on Monday also reported two deaths related to the infectious disease, bringing the state’s death toll to 1,616 …

Scott Gottlieb

Viewpoints: US Needs To Stock Up For COVID, Next Pandemic; How Might A Vaccine Be Distributed Fairly? | Kaiser Health News | 7/27/2020

… for a surge. The federal government would pay the labs for maintaining the extra equipment and materials. (Former FDA Commissioners Scott Gottlieb and Mark McClellan, 7/26) Los Angeles Times: Will A Coronavirus Vaccine Be Distributed … Isn’t ‘Winning’ At Coronavirus Testing. But We Can Capacity for diagnostic tests varies wildly from state to state. Organized contact tracing and isolation of infected people isn’t happening in a meaningful way. It’s a mess …

John Adent

Neogen reports fiscal 2020 results | PR Newswire | 7/21/2020

… reflective of an incredible amount of hard work from our entire team, and I am extremely proud of them,” said John Adent , Neogen’s president and chief executive officer. “While we know that we have a … 19 impact across multiple product lines. Sales of Neogen’s rapid diagnostic tests to detect natural toxins increased 4% in fiscal 2020; our food allergen product line also grew 4% for the year. Revenues at Neogen’s …

Cameron Reynolds

Volition Announces Promising Clinical Trials Results for its Novel COVID-19 Triage Test | PR Newswire | 7/14/2020

… Nucleosomes as potential prognostic markers for COVID-19 disease severity” . Interview with Dr Jake Micallef, Chief Medical Officer and Mr Cameron Reynolds, Chief Executive Officer. Commenting on the results, corresponding author Professor Stefan Holdenrieder , Director … from any additional trials, the effectiveness of Volition’s blood-based diagnostic tests in predicting the progression of complications in COVID-19 and patients with other respiratory diseases, as well as Volition’s ability to develop and …

Jeff Albers

Blueprint Medicines Announces Global Collaboration with Roche to Develop and Commercialize Pralsetinib for Patients with RET-Altered Cancers | Business & Finance | heraldchronicle.com | PR Newswire | 7/14/2020

… and expand development of pralsetinib across multiple treatment settings where there is potential to benefit even broader patient populations,” said Jeff Albers, Chief Executive Officer of Blueprint Medicines. “In addition, the collaboration is transformative for … clinical trials; Blueprint Medicines’ ability to develop and commercialize companion diagnostic tests for its current and future drug candidates; and the success of Blueprint Medicines’ current and future collaborations or licensing arrangements. These and other …

Brett Giroir

White House renews argument that increased cases come from increased testing | Washington Examiner | 7/14/2020

… diagnostic tests. He said earlier this month that if access to testing was lower, “we would have very few cases.” “If you test 40,000,000 people, you are going to have many cases that, without the testing (like other countries), would not show up every night on the Fake Evening News,” Trump said. However, the White House coronavirus testing czar Adm. Brett Giroir broke with Trump and acknowledged on Sunday’s on …

Donald Trump

A key metric — the share of coronavirus tests coming back positive — shows how states’ outbreaks have gotten out of control | Business Insider | 7/8/2020

… The US’s number of new COVID-19 cases grew by 27 percent last week compared to the week before. President Donald Trump has suggested that the higher numbers are simply the product of increased testing … for higher case counts: the positivity rate, the portion of diagnostic tests that come back positive over a given period of time. If testing is increasing and the number of new daily cases in a …

Douglas Bryant

Quidel Announces Preliminary Revenue for Second Quarter 2020 | Business Wire | 7/7/2020

… a small, but important role in helping our high complexity lab customers with their SARS-2 PCR testing needs,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “Later in the quarter, we … a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio …

Nicole Lambert

Myriad Announces New Studies Validating the Ability of Myriad’s riskScore® Test to Modify Breast Cancer Risk Prediction | Globe Newswire | 7/7/2020

… through Myriad’s riskScore test can dramatically alter breast cancer risk both independent of, and in combination with, gene mutations,” said Nicole Lambert, president of Myriad International, Oncology and Women’s Health. “This information can dramatically change … 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 …

Levi Garraway

FDA Approves Genentech’s Phesgo (Fixed-dose Combination of Perjeta and Herceptin for Subcutaneous Injection) for HER2-positive Breast Cancer | Business Wire | 6/29/2020

… approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Phesgo offers … with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify …

Denis Campbell

It’ll take four years for NHS to recover from Covid-19, health chiefs warn | Yahoo News | 6/27/2020

Denis Campbell Health policy editor Photograph: Rui Vieira/PA More The NHS will not be able to get back to providing its full range of services for as long as four years because of the huge disruption caused by Covid-19, hospital bosses warned on Saturday. Patients will face much longer waits than usual for operations and diagnostic tests because hospitals’ drive to remain infection-free means they are closing …

Jack Stover

Interpace Biosciences Announces First Quarter 2020 Financial and Business Results Nasdaq:IDXG | Globe Newswire | 6/25/2020

… lab in Pittsburgh, PA. We have completed validation, acquired acceptable kits and reference samples and are preparing to launch,” stated Jack Stover. “We anticipate second quarter revenue between $5.6 million and $6.0 million, however, we … applications. Clinical services, through Interpace Diagnostics, provides clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management …

Andrew Cuomo

Hospitals resuscitate thousands of delayed elective surgeries | Crain’s New York Business | 6/25/2020

… to the pandemic. All across the state, hospitals ceased nonurgent surgeries to comply with a March 23 order from Gov. Andrew Cuomo. Some patients needing operations deemed safe to postpone, such as those to address … residents or a positivity rate of at least 10% for diagnostic tests. Both measures will be 7-day rolling averages. The states that met that criteria initially are Alabama, Arkansas, Arizona, Florida, North Carolina, South …

Caroline Humer

CVS to Offer Employers COVID-19 Testing Program as U.S. Cases Rise | U.S. News & World Report | 6/24/2020

… outside a CVS store and pharmacy in Medford, Massachusetts, U.S. December 4, 2017. REUTERS/Brian Snyder/File Photo Reuters By Caroline Humer NEW YORK (Reuters) - As U.S. employers grapple with trying to keep workers healthy … other services. CVS declined to provide pricing for the program. Diagnostic tests can cost more than $100 each. While the U.S. government has required health insurers to cover COVID-19 diagnostic testing, that coverage is …

Amy Abernethy

FDA Leverages Real-World Data to Enhance COVID-19 Response | HealthIT Analytics | 6/24/2020

… which has the potential to contribute to the scientific evaluation of diagnostic tools and medical interventions for COVID-19,” said Amy Abernethy, MD, PhD, FDA Principal Deputy Commissioner. “FDA’s participation in the Diagnostics Evidence Accelerator … Accelerator will evaluate the real-world performance of COVID-19 diagnostic tests and antibody tests, and how they are best used to tailor testing strategies to specific populations . Additionally, the project will aim to discover …

Patrick J. Mahaffy

Clovis Oncology to Highlight Rubraca® (rucaparib) and Lucitanib Non-Clinical Data at the AACR Virtual Annual Meeting II 2020 | Business & Finance | manchestertimes.com | Business Wire | 6/17/2020

… our ongoing non-clinical studies underscore our commitment to pursuing innovative research that advances novel therapies for cancer patients,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “In particular, we are pleased to … trials and the corresponding development pathways, effectiveness and suitability of diagnostic tests, the risk that final results of ongoing trials may differ from initial or interim results as a result of factors such as final …

Mike Pence

Pence says second-wave fears are overblown as hospitalizations rise in some states | Washington Examiner | 6/17/2020

V ice President Mike Pence said that fears of a second wave of coronavirus infections were “overblown” as hospitalizations rise in several states. “While talk of an increase in cases dominates cable news coverage, more … of the 12 states also have increased rates of positive diagnostic tests, a sign that the increase in identified cases is not merely a result of greater testing. “The truth is, whatever the media says …

Matt Hancock

Huge backlog in operations building due to lack of PPE and staff testing | Society | The Guardian | 5/25/2020

… 13 days for the outcome of tests, Chris Hopson told the Guardian. In thinly veiled criticism of the health secretary, Matt Hancock , the chief executive of hospital group NHS Providers blamed ministers for repeated failures … resume as soon as possible the normal activities – operations and diagnostic tests – that have been largely suspended since March because of the pandemic. Hospitals cannot do that until doctors and nurses can have regular tests …

Alex Brandon

AP FACT CHECK: Trump, GOP falsehoods on Flynn, Biden, virus | Chron | 5/18/2020

… adviser Peter Navarro walks to do a television interview at the White House, Friday, May 15, 2020, in Washington. Photo: Alex Brandon, AP AP FACT CHECK: Trump, GOP falsehoods on Flynn, Biden, virus 1 / 11 … doing about 300,000. Giroir stressed that an adequate number of diagnostic tests were available for those with symptoms of COVID-19, but studies have shown many who get infected never show symptoms. Dr. Anthony Fauci …

Richard Godfrey

BerGenBio Raises Nok500m (€45.4m) via an Over Subscribed Private Placement | Markets Insider | Business Insider | 5/5/2020

… stemming from the Company’s technology and to progress readiness for early commercialisation possibilities, as well as for general corporate purposes. Richard Godfrey , Chief Executive Officer of BerGenBio, commented: “We are delighted with this financing and … Phase I clinical testing. In parallel, BerGenBio is developing companion diagnostic tests to identify those patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials supporting a precision …

New York, New York

Pomerantz Law Firm Announces the Filing of a Class Action against Chembio Diagnostics, Inc. and Certain Officers - CEMI | PR Newswire | 7/7/2020

… Action against Chembio Diagnostics, Inc. and Certain Officers - CEMI News provided by Jul 06, 2020, 20:36 ET Share this article NEW YORK , July 6, 2020 /PRNewswire/ – Pomerantz LLP announces that a class action lawsuit has … its subsidiaries, develops, manufactures, and commercializes point-of-care (“POC”) diagnostic tests that are used to detect or diagnose diseases. Amidst the SARS-CoV-2, or COVID-19, pandemic, the Company focused on the development …

State of New York

Pomerantz Law Firm Announces the Filing of a Class Action against Chembio Diagnostics, Inc. and Certain Officers - CEMI | PR Newswire | 7/7/2020

… Action against Chembio Diagnostics, Inc. and Certain Officers - CEMI News provided by Jul 06, 2020, 20:36 ET Share this article NEW YORK , July 6, 2020 /PRNewswire/ – Pomerantz LLP announces that a class action lawsuit has … its subsidiaries, develops, manufactures, and commercializes point-of-care (“POC”) diagnostic tests that are used to detect or diagnose diseases. Amidst the SARS-CoV-2, or COVID-19, pandemic, the Company focused on the development …

York, Pennsylvania

Pomerantz Law Firm Announces the Filing of a Class Action against Chembio Diagnostics, Inc. and Certain Officers - CEMI | PR Newswire | 7/7/2020

… against Chembio Diagnostics, Inc. and Certain Officers - CEMI News provided by Jul 06, 2020, 20:36 ET Share this article NEW YORK , July 6, 2020 /PRNewswire/ – Pomerantz LLP announces that a class action lawsuit has been … its subsidiaries, develops, manufactures, and commercializes point-of-care (“POC”) diagnostic tests that are used to detect or diagnose diseases. Amidst the SARS-CoV-2, or COVID-19, pandemic, the Company focused on the development …

State of Washington

Tracing ‘patient zero’: why America’s first coronavirus death may for ever go unmarked | World news | The Guardian | 5/26/2020

… spreading through the US before the Trump administration restricted travel from China, before the US had a reliable supply of diagnostic tests, and before the disease caused by the virus was even named. Models of … the US came on 21 January, when a man in Washington state who had traveled to Wuhan, China, tested positive. The Seattle area soon became a hotspot, with cases soaring after an outbreak at a …

State of Minnesota

National coronavirus updates: Governors balance reopening as US death toll inches toward 90,000 | 5/18/2020

… measles,” wrote Cristi Bramer and colleagues at the Michigan Department of Health and Human Services, the Immunization Action Coalition in Minnesota and the Children’s Hospital of Philadelphia.They noted that measures aimed at curbing the spread … Andrew Cuomo, who added the state is doing “significantly more” diagnostic tests by population than other countries.Officials have said the state is past its peak. And the governor said Sunday two more regions — in addition …

State of Texas

Minnesota is prepared for a COVID-19 second act | Star Tribune | 6/13/2020

… as a double whammy in the fall with the start of influenza season. Roughly a dozen states including Arizona, Florida, Texas and Utah have seen recent case growth, including some growth in severe COVID-19 … were missed in the past. Minnesota on Thursday reported 13,391 diagnostic tests — its second-highest daily tally so far in the pandemic. Free testing took place this week at four sites in Minneapolis and St …

State of California

OncoCyte (NYSEAMERICAN:OCX) Downgraded to Sell at Zacks Investment Research | 6/17/2020

diagnostic tests for detection of cancer. OncoCyte Corporation is based in Alameda, California. “ Get OncoCyte alerts: Several other equities research analysts have also recently issued reports on OCX. Chardan Capital reaffirmed a buy rating and issued a $7.75 target price on shares of OncoCyte in a report on Wednesday, May 13th. Needham & Company LLC assumed coverage on OncoCyte in a research note on Tuesday, June 2nd. They set a buy …

State of Florida

Minnesota is prepared for a COVID-19 second act | Star Tribune | 6/13/2020

… come as a double whammy in the fall with the start of influenza season. Roughly a dozen states including Arizona, Florida, Texas and Utah have seen recent case growth, including some growth in severe COVID … were missed in the past. Minnesota on Thursday reported 13,391 diagnostic tests — its second-highest daily tally so far in the pandemic. Free testing took place this week at four sites in Minneapolis and St …

State of Michigan

National coronavirus updates: Governors balance reopening as US death toll inches toward 90,000 | 5/18/2020

… in the early days of testing.More evidence US childhood vaccinations dropping during virus outbreakThe number of childhood vaccines administered in Michigan has dropped by as much as 22% amid the coronavirus pandemic, according to a … Andrew Cuomo, who added the state is doing “significantly more” diagnostic tests by population than other countries.Officials have said the state is past its peak. And the governor said Sunday two more regions — in addition …

State of Virginia

Genetworx Laboratories Announces New COVID-19 Antibody Test with 99.8 Percent Specificity and Rapid Test Result Notification System for Patients and Providers | PR Newswire | 6/19/2020

… 19, 2020 /PRNewswire/ – Genetworx Laboratories , a leading innovative molecular diagnostic testing laboratory, announced today that the company is now performing COVID-19 antibody testing, in addition to diagnostic testing, for the virus. The Virginia -based company stated that it is providing the new antibody blood test in response to the demand from physicians’ offices, emergency management providers, government, assisted living entities, and employers all over the United States . The Genetworx …

State of Georgia

8 more states could be added to New York quarantine order | 6/29/2020

… Network New York shows eight states were in line to be added to the list as of Sunday night: California, Georgia, Iowa, Idaho, Louisiana, Mississippi, Nevada and Tennessee. That would double the original list of … a rolling seven-day average: Having 10% of COVID-19 diagnostic tests come back positiveHaving at least 10 daily positive tests for every 100,000 residents Cuomo, New Jersey Gov. Phil Murphy and Connecticut Gov. Ned …

State of Arizona

8 more states could be added to New York quarantine order | 6/29/2020

… That would double the original list of states that qualified when the order was first unveiled last week: Alabama, Arkansas, Arizona, Florida, North Carolina, South Carolina, Texas and Utah, all of which continue to qualify … a rolling seven-day average: Having 10% of COVID-19 diagnostic tests come back positiveHaving at least 10 daily positive tests for every 100,000 residents Cuomo, New Jersey Gov. Phil Murphy and Connecticut Gov. Ned …

State of New Jersey

8 more states could be added to New York quarantine order | 6/29/2020

ALBANY – Travelers from eight additional states — including California — could soon be added to New York, New Jersey and Connecticut’s mandatory quarantine order, which would push the total to 16 states representing nearly half the country’s … a rolling seven-day average: Having 10% of COVID-19 diagnostic tests come back positiveHaving at least 10 daily positive tests for every 100,000 residents Cuomo, New Jersey Gov. Phil Murphy and Connecticut Gov. Ned …

State of Massachusetts

3M pairs with MIT to develop a paper-based coronavirus diagnostic test | FierceBiotech | 7/15/2020

3M is working with researchers from the Massachusetts Institute of Technology to develop a fast COVID-19 diagnostic using a simple, paper-based test that they hope will be easy to mass produce. The test … toward the goal of providing millions of new COVID-19 diagnostic tests by this fall …

State of Utah

8 more states could be added to New York quarantine order | 6/29/2020

… that qualified when the order was first unveiled last week: Alabama, Arkansas, Arizona, Florida, North Carolina, South Carolina, Texas and Utah, all of which continue to qualify. Add it up and New York, New Jersey … a rolling seven-day average: Having 10% of COVID-19 diagnostic tests come back positiveHaving at least 10 daily positive tests for every 100,000 residents Cuomo, New Jersey Gov. Phil Murphy and Connecticut Gov. Ned …

Denver, Colorado

SpeeDx and Roche Partner to Expand Access to Antibiotic Resistance Tests | 6/18/2020

… Denver, SpeeDx CEO. “Our innovative diagnostic tests go beyond simple pathogen detection and support Resistance Guided Therapy – providing information on antibiotic resistance to empower clinicians with the information they need to make appropriate treatment decisions.” Rising rates of antibiotic resistance are a serious global problem. New, technologically advanced diagnostics help clinicians choose the best targeted therapy for individual patients based on the resistance status of their infection. This helps conserve …

State of Alabama

8 more states could be added to New York quarantine order | 6/29/2020

… and Tennessee. That would double the original list of states that qualified when the order was first unveiled last week: Alabama, Arkansas, Arizona, Florida, North Carolina, South Carolina, Texas and Utah, all of which continue … a rolling seven-day average: Having 10% of COVID-19 diagnostic tests come back positiveHaving at least 10 daily positive tests for every 100,000 residents Cuomo, New Jersey Gov. Phil Murphy and Connecticut Gov. Ned …

State of Kentucky

Pence says second-wave fears are overblown as hospitalizations rise in some states | Washington Examiner | 6/17/2020

Kentucky and Utah, are running low on available space in intensive care units, according to data maintained by COVID Exit Strategy. Ten of the 12 states also have increased rates of positive diagnostic tests, a sign that the increase in identified cases is not merely a result of greater testing. “The truth is, whatever the media says, our whole-of-America approach has been a success,” Pence wrote. “That’s a …

Washington, District of Columbia

Coronavirus Disease Weekly News 27June 2020 | 6/28/2020

… an outlier,” citing studies with higher accuracy rates. Though the Abbott rapid test is one of over 100 COVID-19 diagnostic tests to receive FDA emergency use authorization during the pandemic, President Donald Trump has … the virus, about two hundred people altogether. In Yakima County, Washington, home to the nation’s largest tree fruit crop, 500 workers have fallen ill from the virus. There are nearly 1,000 cases in the Immokalee …

State of Connecticut

8 more states could be added to New York quarantine order | 6/29/2020

ALBANY – Travelers from eight additional states — including California — could soon be added to New York, New Jersey and Connecticut’s mandatory quarantine order, which would push the total to 16 states representing nearly half the country’s … a rolling seven-day average: Having 10% of COVID-19 diagnostic tests come back positiveHaving at least 10 daily positive tests for every 100,000 residents Cuomo, New Jersey Gov. Phil Murphy and Connecticut Gov. Ned …

Los Angeles, California

Coronavirus Disease Weekly News 27June 2020 | 6/28/2020

… Disease Control and Prevention on whether to test for COVID-19. Orange County has nine of the cases, as does Los Angeles County. Kern County has identified two respiratory deaths that might suggest COVID-19 … Abbott rapid test is one of over 100 COVID-19 diagnostic tests to receive FDA emergency use authorization during the pandemic, President Donald Trump has featured the product in the White House Rose Garden and …

State of Louisiana

8 more states could be added to New York quarantine order | 6/29/2020

… shows eight states were in line to be added to the list as of Sunday night: California, Georgia, Iowa, Idaho, Louisiana, Mississippi, Nevada and Tennessee. That would double the original list of states that qualified … a rolling seven-day average: Having 10% of COVID-19 diagnostic tests come back positiveHaving at least 10 daily positive tests for every 100,000 residents Cuomo, New Jersey Gov. Phil Murphy and Connecticut Gov. Ned …

State of Maryland

Structured ‘cut-and-paste’ design enables streamlined development of SARS-CoV-2 molecular probes | 6/25/2020

… COVID-19). At the moment, there are no approved vaccines or targeted therapeutics for the treatment of this disease, while diagnostic tests are still striving to achieve optimal sensitivity and specificity. On the other hand … at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Credit: NIAID The promise of molecular probes Molecular probes with the affinity for key targets of certain viruses can be of broad utility. They …

State of Arkansas

8 more states could be added to New York quarantine order | 6/29/2020

… Tennessee. That would double the original list of states that qualified when the order was first unveiled last week: Alabama, Arkansas, Arizona, Florida, North Carolina, South Carolina, Texas and Utah, all of which continue to … a rolling seven-day average: Having 10% of COVID-19 diagnostic tests come back positiveHaving at least 10 daily positive tests for every 100,000 residents Cuomo, New Jersey Gov. Phil Murphy and Connecticut Gov. Ned …

State of Illinois

The Definitive Guide to pckeeper live | 6/27/2020

The Definitive Guide to pckeeper live The Definitive Guide to pckeeper live Category: Blog Two class action lawsuits are submitted towards Kromtech with the Mac OS version of PCKeeper, MacKeeper. The 1st lawsuit, filed in Illinois, alleges that “Contrary to ZeoBIT’s marketing and in-application representations, however, neither the totally free demo nor the full registered versions of MacKeeper complete any credible diagnostic tests of a person’s Mac. Instead, ZeoBIT …