Roche gets 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 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.
With extensive global manufacturing capabilities, Roche will be able to deliver high double-digit millions of tests per month. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world.
For countries with specific regulatory requirements, local approval timelines apply. In addition there may be other country-specific regulations, such as import requirements, which will determine when the test becomes available locally. Roche will work closely with the respective regional representatives to ensure we appropriately support local registration efforts.
