Roche's COVID-19 antibody test gets FDA emergency use approval

Roche (OTCQX:RHHBY) says the U.S. Food and Drug Administration issued an emergency use authorization for its new Elecsys antibody test to help determine if people have been infected with the coronavirus.

Roche says the new test, which has a specificity greater than 99.8%, 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 the virus.

The company says it has already started shipping the test to laboratories globally and will ramp up production capacity to high double-digit millions per month for countries accepting the CE mark as well as the U.S.


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