The US FDA Grants Emergency Use Authorization to Roche’s Four-In-One Nucleic Acid Test
Shots:
- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
