ZURICH (Reuters) -Roche said on Friday it launched a laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients, as very high demand for tests prompts the Swiss drugmaker to offer new options to the market.
The Elecsys SARS-CoV-2 antigen test is an automated laboratory assay intended as an aid in diagnosis of active SARS-CoV-2 infection, Roche said in a statement.
Roche said it would be able to ramp up to a double-digit million number of tests per month by early 2021.
It said the Elecsys SARS-CoV-2 Antigen test showed a 94.5% sensitivity across 200 PCR confirmed symptomatic individuals and a 99.9% specificity across 2,747 PCR negative symptomatic and screening individuals.
Roche has also filed for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration.
(Reporting by Silke Koltrowitz; Editing by Thomas Seythal and Christopher Cushing)