Roche’s COVID-19 antibody test received FDA Emergency Use Authorization and is available in markets accepting the CE mark

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On May 2, 2020, Roche announced that the 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.

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Source: Roche
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