FDA Week - 04/03/2020

Consumer Lab Test Companies Pursuing EUA For At-Home Tests

By Beth Wang / March 27, 2020 at 5:35 PM
Consumer diagnostic testing companies are working with FDA to get emergency use authorization for at-home COVID-19 tests and telehealth consultations with health care professionals. One at-home diagnostics testing company, Everlywell, had originally planned to make its at-home test available for consumers by March 23, saying that it was authorized to do so because the swab samples would be tested by Clinical Laboratory Improvement Amendment-certified labs, which FDA has authorized to conduct COVID-19 tests . The company also planned to offer...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.