On May 2, 2020, Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization for its new Elecsys Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2.

Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to high double-digit millions per month to serve healthcare systems in countries accepting the CE mark, as well as the U.S.

Roche’s SARS-CoV2 antibody test, which has a specificity greater than 99.8% and 100% sensitivity (14 Days post-PCR confirmation), can help assess patients’ immune response to the virus. As more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up immunity to the 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.