GBC Blog

GenomicTree said that it would start the shipment of its COVID-19 molecular diagnostic kit to Los Angeles, CA. Currently, the U.S. permits COVID-19 molecular diagnostic products to enter its market through two channels – the Food and Drug Administration’s “Emergency Use Authorization (EUA) system,” and the verification procedures of the state-managed Clinical Laboratory Improvement Amendments…

MaAs labs and diagnostic developers race to meet demand for assays to detect the SARS-CoV-2 coronavirus, 360Dx is updating this tracker on a regular basis in order to provide readers with up-to-date and accurate information on the regulatory status of these tests in the US, European, and Asian markets. The tracker includes only those tests…

March 24, 2020 MARCY L’ÉTOILE, France–(BUSINESS WIRE)–Regulatory bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that its subsidiary, BioFire Defense, has received Emergency Use Authorization by the U.S. Food and Drug Administration of its BIOFIRE® COVID-19 test for use in CLIA moderate and high complexity clinical laboratories to detect…

IRVINE, Calif., March 17, 2020 /PRNewswire/ — Physician-scientists at the University of California, San Diego (UCSD) are the first to evaluate a new diagnostic testing system designed by Irvine, CA-based Fluxergy, that holds promise for identifying the SARS-CoV-2 virus (also known as the novel coronavirus) in as little as 45 minutes and typically within one…

Business Wire – March 10, 2020 – bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, is announcing the forthcoming launch of 3 different tests to address the COVID-19 epidemic and to meet the different needs of physicians and health authorities in the fight against this emerging infectious disease. bioMérieux has finalized…

March 11, 2020, Leah Lawrence – Researchers say they can distinguish between lesions that are benign and those that could become invasive — but the technology required is not yet used routinely. Testing only occurred among symptomatic patients. Circulating microDNA profiles may serve as a useful tool for lung cancer detection in symptomatic patients when…

By DAVID LIM and BRIANNA EHLEY 03/10/2020 06:56 PM EDT A looming shortage in lab materials is threatening to delay coronavirus test results and cause officials to undercount the number of Americans with the virus. The slow pace of coronavirus testing has created a major gap in the U.S. public health response. The latest problem…

As the threat of the novel coronavirus continues to grow globally, innovative biopharmaceutical companies are ramping up efforts to study the virus and develop vaccines and cures to protect individuals from contracting the virus. More than 75,000 cases have been confirmed worldwide—and the numbers are climbing with over 1,000 cases outside mainland China, where the…

Bethesda, Maryland (Feb. 18, 2020) – Patients at average risk of colorectal cancer who have a normal colonoscopy do not need to repeat screening for 10 years. It is common for polyps to be removed and tested during a colonoscopy, but the amount and size of polyps removed will change the patient’s follow-up screening schedule.…

With superbugs causing upwards of 35,000 deaths per year, the global antibiotic crisis is intensifying, says the World Health Organization (WHO)—and depending which direction policymakers go, antimicrobial resistance (AMR) could either be relieved or exacerbated by policy.  The problem: “Declining private investment and lack of innovation in the development of new antibiotics are undermining efforts to combat drug-resistant…