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Roche Gets FDA Emergency Use Authorization for Rapid Coronavirus, Flu Test

NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for a rapid version of Roche Molecular Systems' Cobas SARS-CoV-2 & Influenza A/B test.

The RT-PCR-based test is designed to simultaneously detect and differentiate SARS-CoV-2, influenza A, and influenza B in healthcare provider-collected nasopharyngeal and nasal swabs, or nasal swabs self-collected in a healthcare setting. The test is designed to run on Roche Molecular Diagnostics' benchtop Cobas Liat system, providing results for single samples within 20 minutes in either a point-of-care or clinical laboratory setting, according to the company.

Earlier this month, Roche announced that it had received EUA from the FDA for a version of the Cobas SARS-CoV-2 & Influenza A/B test designed to run on its Cobas 6800/8800 systems, which provide results in about three hours.