Oct 6, 2020 | News, Regulatory
GlaxoSmithKline (GSK) and Vir Biotechnology are partnering to conduct trials on an antibody for COVID-19 treatment. The clinical trial will include 1,300 patients globally and a control group receiving a placebo. Various other companies, Regeneron for instance, have... 
Sep 29, 2020 | News, Regulatory
On Friday (9/25), the Centers for Medicare & Medicaid Services (CMS) published a revised guide to expedite the process in which laboratories receive approval for COVID-19 testing. To aid in combatting the novel virus, the CMS program’s goal is to eliminate the lag... 
Sep 28, 2020 | News, Regulatory
Today (9/28), Hologic received emergency use authorization (EUA) from the FDA for their testing kit for individuals with no symptoms of COVID-19. The CDC recently rescinded their statement saying that asymptomatic people did not need to be tested for COVID-19 and... 
Aug 6, 2020 | News, Regulatory
The FDA issued yesterday (8/5) Emergency Use Authorization for Vela Diagnostics for the manual version of their COVID-19 PCR test. The manual version of the test enables flexible sample processing, facilitating widespread use of the test throughout the United States....
