GBC Blog

Scientists are piecing together how SARS-CoV-2 operates, where it came from and what it might do next — but pressing questions remain about the source of COVID-19. Nature 581, 22-26 (2020) doi: 10.1038/d41586-020-01315-7 PDF version In 1912, German veterinarians puzzled over the case of a feverish cat with an enormously swollen belly. That is now…

Vela Diagnostics said on Thursday it has received provisional authorization from Singapore’s Health Sciences Authority for the firm’s ViroKey SARS-CoV-2 RT-PCR Test. As a result, Vela can offer the test to healthcare institutes, private hospitals, medical clinics, and clinical laboratories licensed in Singapore. The test is a probe-based reverse transcription PCR test for detecting the…

07-APR-2020. German engineering and technology company Bosch has said its rapid test can detect a SARS-CoV-2 coronavirus infection in patients within two-and-a-half hours. Developed in just six weeks, the test for COVID-19 can help medical facilities make fast diagnoses and play a part in containing the coronavirus pandemic. Another advantage of the rapid test is…

IRVINE, Calif., March 30, 2020 /PRNewswire/ — Fluxergy LLC, a research and medical diagnostic test company based in Irvine California, has submitted an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) Center For Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company’s high-speed Research Use Only…

SINGAPORE, March 29, 2020 /PRNewswire/ — Ahead of Emergency Use Authorization (EUA) and in accordance with the U.S. Food and Drug Administration (FDA) Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency guidance document issued on March 16, 2020, Vela Diagnostics will offer the manual ViroKey™ SARS-CoV-2 RT-PCR Test when validation is…

By HospiMedica International – 28 Mar 2020.Global diagnostics company Randox Laboratories (Crumlin, UK) and leading technology manufacturer Bosch Healthcare Solutions GmbH (Waiblingen, Germany) will launch a game-changing point of care coronavirus test in April 2020. The Vivalytic Viral Respiratory Tract Infection (VRI) Array can identify SARS-CoV-2 (COVID-19) and differentiate it from nine other respiratory infections…

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…