The US FDA Grants Emergency Use Authorization to Roche’s Four-In-One Nucleic Acid Test


The US FDA has granted EUA to the company’s four-in-one cobas liat nucleic acid test to diagnose infections due to SARS-CoV-2, influenza A/B virus and respiratory syncytial virus (RSV)
The nucleic acid test, an automated multiplex RT-PCR test, aims at diagnosing and distinguishing SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus (RSV) RNA using the patient’s anterior nasal swab and nasopharyngeal swab specimens
In Addition, Roche is looking for the US FDA’s 510(k) clearance and a CLIA waiver in 2025 with plans to launch the test globally post CE-IVDR approval

Ref: Roche | Image: Roche

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