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Roche Multiplex SARS-CoV-2, Flu Test Gets FDA Emergency Use Authorization

NEW YORK – The US Food and Drug Administration said Thursday that it has granted Roche Emergency Use Authorization for a new version of its multiplex molecular assay for detecting SARS-CoV-2 and influenza A/B.

The Cobas SARS-CoV-2 & Influenza A/B V2 is a real-time RT-PCR assay to qualitatively detect and differentiate SARS-CoV-2, influenza A, and influenza B RNA in a nasal or nasopharyngeal swab sample from a patient with suspected respiratory infection consistent with COVID-19. It is designed to run on Roche's Cobas 6800/8800 instruments.

Roche was previously granted FDA EUA in September 2020 for the Cobas SARS-CoV-2 & Influenza A/B assay, which was also designed for use on the Cobas 6800/8800 systems. That test also has been available in countries that accept the CE mark.

FDA officials said early this year that, after issuing more than 400 EUAs for COVID-19 tests, they were winding down EUA reviews for diagnostic tests and encouraging test developers to pursue non-emergency regulatory clearance pathways. The agency has continued issuing some EUAs in recent months for respiratory tests from firms including Princeton BioMeditech, 3EO Health, Tangen Biosciences, SD Biosensor, and MAWD Laboratories.