The closed system design of Roche’s tests minimises the risks of contamination. Credit: Michael Derrer Fuchs / Shutterstock.

Roche has received 510(k) clearance with a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver from the US Food and Drug Administration (FDA) for its cobas liat sexually transmitted infection (STI) multiplex assay panels.

Tests for chlamydia and gonorrhoea (CT/NG) and chlamydia, gonorrhoea, and Mycoplasma genitalium (CT/NG/MG) are included in the panels, allowing for the diagnosis and differentiation of several STIs from one sample.

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The cobas liat STI tests are set to be exclusively available in the country’s market in the following months, with plans for commercialisation under the CE mark anticipated soon.

Leveraging gold-standard PCR technology, the cobas liat system claims to deliver outcomes in under 20 minutes.

Designed for ease of use in near-patient settings, the cobas liat assays require minimal training, ensuring rapidness for healthcare professionals.

The closed system design of cobas liat also minimises contamination risks, thus improving result dependability.

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Roche Diagnostics CEO Matt Sause said: “Rapid molecular point-of-care testing can revolutionise the clinical management of STIs in decentralised and community-based healthcare settings, enabling informed treatment strategies, better health outcomes for patients, and contain further spread by providing timely diagnosis.”

The assays join an existing suite of tests for the cobas liat system, which include singleplex and multiplex assays for various pathogens such as influenza A and B, SARS-CoV-2, among others.

These assays can be integrated into existing testing programmes through the cobas infinity edge, which facilitates remote updates and troubleshooting.

Roche is also developing assays for other infectious diseases, with the cobas liat system already commercially available in select markets.

Last month, the company secured CE mark certification for its updated cobas 6800/8800 systems 2.0, enhancing laboratory and testing capabilities.