Roche has received emergency use authorisation from the US 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 (RT-PCR) assay, which can produce results in 20 minutes, is designed for use on the cobas liat system.
It can detect and differentiate between SARS-CoV-2, influenza A, B virus, and RSV from either a single nasopharyngeal or anterior nasal swab sample.
Suitable for a range of healthcare settings, the test aims to expedite clinical decision-making, facilitate targeted treatments, help reduce antibiotic use, and improve patient outcomes.
Roche's new test expands its portfolio of diagnostic solutions for respiratory illnesses. It complements existing assays on the cobas liat system, including tests for SARS-CoV-2, Strep A, and co-infections of SARS-CoV-2 with influenza A/B.
Roche Diagnostics CEO Matt Sause said: “Diagnostics play a critical role in the fight against respiratory illness.
“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.”
Roche plans to seek 510(k) clearance from the FDA and a Clinical Laboratory Improvement Amendments (CLIA) waiver for the test in the US next year.
The company plans for a commercial launch of the test in other markets after securing CE-IVDR approval.
Last month, Roche obtained the FDA’s breakthrough device designation for its Tina-quant lipoprotein Lp(a) RxDx assay, a diagnostic tool for cardiovascular disease risk.
