Roche plans to seek FDA 510(k) clearance for the test in the US. Credit: Louis Reed on Unsplash.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

Roche Diagnostics CEO Matt Sause said: “Diagnostics play a critical role in the fight against respiratory illness.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.