GBC Blog

The agency granted emergency clearance for a testing kit that allows a consumer to take a nasal sample at home and send it to a laboratory for the diagnosis. The Food and Drug Administration on Saturday granted emergency clearance for a coronavirus testing kit that will enable individuals to take a nasal sample at home…

(Reuters) – An at-home coronavirus testing project in Seattle backed in part by the Bill and Melinda Gates Foundation said on Saturday it was working with U.S. regulators to resume the program after being suspended by the Food and Drug Administration. The Seattle Coronavirus Assessment Network (SCAN), which aims to monitor the spread of the…

IRVINE, California, May 13, 2020 /PRNewswire/ — Irvine, California-based Fluxergy LLC, a diagnostic test company, is making a $30 million investment to expand its capability to scale production of the Fluxergy Analyzer diagnostic testing system in response to the COVID-19 pandemic. The Fluxergy system, utilizing state-of-the-art PCR and microfluidics technology, has been shown to accurately identify the SARS-CoV-2 virus in one…

Published: May 08, 2020 By Alex Keown Rutgers’ RUCDR Infinite Biologics received an amended Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results. The new at-home saliva self-collection assay, developed by RUCDR in partnership with Utah-based Spectrum Solutions…

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…