FDA grants EUA for Roche's COVID-19 antibody test

Under exceptional arrangements in relation to the novel coronavirus pandemic, the US Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the new Elecsys Anti-SARS-CoV-2 antibody test.

The test, from Swiss pharma giant Roche (ROG: SIX), 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 USA.

“Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis,” said Severin Schwan, chief executive Roche Group, in a press release on Sunday. ”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis,” he noted.

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.

Extensive production capabilities