Roche gets U.S. FDA emergency use approval for COVID-19 antibody test

Roche Holding AG received emergency use approval from the U.S. Food and Drug Administration for an antibody test to help determine if people have ever been infected with the coronavirus, the Swiss drugmaker said http://pdf.reuters.com/htmlnews/htmlnews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20200503:nGNE71pdqt on Sunday.

The drugmaker said its antibody test, Elecsys Anti-SARS-CoV-2, has a specificity greater than 99.8% and can help assess patients' immune response to the COVID-19 virus.