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

The serology test has a specificity greater than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation)The high specificity of the test is crucial to determine reliably if a person has been exposed to the virus and if the patient has developed antibodiesRoche will provide high double-digit millions of tests already in May for countries accepting the CE mark and in the U.S. under Emergency Use Authorization, further ramping up capacities thereafterThe test is available on Roche’s cobas e analysers which are widely available around the worldBasel, 03 May 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA)¹ 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 mark² as well as the U.S.Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
– Nicolas Dunant (Head)
– Patrick Barth
– Daniel Grotzky
– Karsten Kleine
– Nathalie Meetz
– Barbara von Schnurbein
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