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Roche Nabs Emergency Use Authorization From FDA for Multiplex SARS-CoV-2, Flu Test

NEW YORK – Roche announced Friday that its Cobas SARS-CoV-2 & Influenza A/B test received Emergency Use Authorization from the US Food and Drug Administration. 

The RT-PCR test runs on Roche's Cobas 6800/8800 systems and is intended to qualitatively detect and differentiate SARS-CoV-2, influenza A, and influenza B from one nasal or nasopharyngeal sample. The multiplex test is also available in countries accepting the CE mark.

The systems can provide 96 results in approximately three hours, while the Cobas 6800 instrument can provide 384 results in eight hours and the Cobas 8800 machine can provide 1,056 results in the same time frame. 

“With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone," Roche Diagnostics CEO Thomas Schinecker said in a statement. "Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients.”