FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers.”
Still, as we previously reported, no diagnostic test had been authorized for at-home collection by Americans. But that changed last Tuesday when FDA authorized the first diagnostic test with an at-home collection option for COVID-19. Specifically, the agency re-issued an EUA for the Laboratory Corporation of America’s (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home.
Read the article on our Class Dismissed blog.
Morrison & Foerster’s COVID-19 Resource Center also provides updated multidisciplinary guidance to help you face these evolving issues.