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Roche coronavirus antibody test receives FDA Emergency Use Authorization

Christian Fernsby |
Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its new Elecsys Anti-SARS-CoV-2 antibody test.

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Topics: ROCHE    CORONAVIRUS   

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% sensitivity3 (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.