Roche Ships First 400,000 COVID-19 Tests
Labs across U.S. to begin patient testing under FDA Emergency Use Authorization
Roche plans to ship an additional 400,000 tests per week to the lab testing sites across the nation that are set up to run the test immediately under the guidelines of the U.S. FDA Emergency Use Authorization (EUA).
Under the EUA, the cobas SARS-CoV-2 Test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in patients who meet COVID-19 clinical and/or epidemiological criteria for testing. The test uses nasopharyngeal or oropharyngeal swab samples.
Roche consulted with government agencies to ensure that the test distribution prioritizes labs with the broadest geographic reach and highest patient impact. Healthcare providers across the entire U.S. can send patient samples to these laboratories for processing.
The labs run the test on Roche's fully automated cobas 6800 and cobas 8800 Systems, which can process up to 384 results (cobas 6800 System) and 960 results (cobas 8800 System) in an 8-hour shift. After the lab starts the test, results are available in about three-and-a-half hours.