Roche (RHHBY) announced that the U.S. Food and Drug Administration has granted Emergency Use Authorization for its cobas liat SARS-CoV-2, Influenza A/B, and RSV nucleic acid test. This test is an automated multiplex real-time polymerase chain reaction (RT-PCR) assay performed on the cobas liat system.
Capable of delivering results within 20 minutes using a compact analyzer suitable for most healthcare settings, this test requires either a single nasopharyngeal or anterior nasal-swab sample. It effectively confirms or rules out infections with SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
Roche plans to seek FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver in the United States for this new test by 2025, with further plans for commercial launch in other global markets following CE-IVDR approval.
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