FDA issues first Emergency Use Authorization for point-of-care diagnostic

March 22, 2020 by Chain Drug Review COVID-19, epheid Xpert Xpress SARS-CoV-2 test, FDA, FDA Commissioner Dr. Stephen Hahn, HHS Secretary Alex Azar Leading Headlines, Pharmacy

WASHINGTON — The U.S. Food and Drug Administration issued the first Emergency Use Authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. “The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out