Roche’s SARS-CoV-2 Test Receives EUA

U.S. FDA has issued an Emergency Use Authorization (EUA) for Roche’s cobas SARS-CoV-2 Test. It is intended for the detection of SARS-CoV-2, the virus that causes COVID-19 disease, in swab samples from patients who meet COVID-19 clinical criteria for testing. Hospitals and reference labs can run the test on Roche’s automated cobas 6800 and cobas 8800 Systems, which are widely available in the U.S. and around the world.

The cobas 6800/8800 Systems provide test results in three and half hours with up to 96 results and in about three hours and a total of 1,440 results, respectively.  

Upon authorization, Roche will have millions of tests a month available for use on the cobas 6800 and 8800 systems.