Medicosnext
Basel, 13 March 2020 – Roche, a global pioneer in pharmaceuticals and diagnostics, announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing. Hospitals and reference laboratories can run the test on Roche’s fully automated cobas® 6800/8800 Systems, which are widely available in the U.S. and around the world. The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.
The widely available Roche’s cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test, provide test results and offer improved operating efficiency, flexibility, and fastest time-to-results with the highest throughput with up to 96 results in about three and a half hours and a total of 384 results for the cobas 6800 System and 960 results for the cobas 8800 System in 8 hours. The test can be run simultaneously with other assays provided by Roche for use on the cobas 6800/8800 Systems. The cobas SARS-CoV-2 is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. In the United States, the cobas SARS-CoV-2 is only for use under the FDA’s Emergency Use Authorization.
For more information about the tests and system, please visit www.diagnostics.roche.com
