Roche has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Cobas Liat SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV) nucleic acid test.
The rapid multiplex real-time reverse transcription polymerase chain reaction assay is designed for use on the Cobas Liat system. It can detect and differentiate between SARS-CoV-2, the influenza A and B viruses, and RSV from either a single nasopharyngeal or anterior nasal swab sample and produces results in 20 minutes.
The test is authorized for use at point-of-care settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation.
In a statement, Roche noted that it intends to pursue FDA 510(k) clearance and a CLIA waiver for the test; the company has plans for commercial launch in other markets worldwide after gaining CE-IVDR approval.
The new assay expands Roche's portfolio of tests for respiratory illnesses for the Cobas Liat system, which already includes tests for SARS-CoV-2, strep A, SARS-CoV-2 and influenza A/B, and influenza A/B and RSV.
