FDA authorizes first COVID-19 point-of-care diagnostic

FDA granted Emergency Use Authorization to Cepheid’s Xpert Xpress SARS-CoV-2 test, the first point-of-care diagnostic for COVID-19. The approval of the test, which can be run in 45 minutes, is FDA’s latest step to ramp up diagnostic capacity in the U.S.

Current testing for COVID-19 in the U.S. is centered on PCR-based tests that have limited capacity, take several hours to read out and need to be run in centralized or references labs. ...