The FDA just authorized its first coronavirus blood test. What does that mean?
On Wednesday, the US Food and Drug Administration issued an emergency use authorization (EUA) to Cellex, a North Carolina pharmaceutical company, for a new finger-prick blood test that can detect an immune reaction to SARS-CoV-2. It’s not the first test to get this thumbs-up from the FDA: At least two dozen other tests that search for the virus’s genetic material on a throat swab have already received an EUA. The authorization, like those that came before, clearly states “This test has not been FDA cleared or approved.”