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 The CDC recently rescinded their statement saying that asymptomatic people did not need to be tested for COVID-19 and...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 PCR test. The manual version of the test enables flexible sample processing, facilitating widespread use of the test throughout the United States. Sam...
