U.S. FDA grants Roche emergency use approval for coronavirus antibody test
Swiss drugmaker Roche announced on Sunday that it received an emergency use authorisation from the U.S. Food and Drug Administration (FDA) for a coronavirus antibody test.
According to Roche, the test – named Elecsys Anti-SARS-CoV-2 – is able to determine if people have ever been infected with the coronavirus and developed antibodies against it.
Roche said the test has a specificity greater than 99.8 percent and can help assess people’s immune response to the virus.
The company added that it had already started shipping the new antibody test to top laboratories worldwide and would increase production to “high double-digit millions per month.”