NEW YORK – Roche announced Monday that its four-in-one molecular test for SARS-CoV-2, influenza A/B, and respiratory syncytial virus has received Emergency Use Authorization from the US Food and Drug Administration.
The Cobas Liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test qualitatively detects and differentiates between the viruses from a single nasopharyngeal or anterior nasal swab sample within 20 minutes, Roche said in a statement. The test is authorized for use at the point of care.
The company added that it intends to seek 510(k) clearance and a CLIA waiver for the PCR-based test next year, with plans for commercial launch in other markets after the test receives CE-IVDR approval.
"Diagnostics play a critical role in the fight against respiratory illness,” Roche Diagnostics CEO Matt Sause said in a statement. "We are proud to provide this innovative test to address the significant burden placed on healthcare systems. Now, healthcare professionals will be able to detect and differentiate these respiratory viruses within a single patient visit, enabling improved public health outcomes."