Image: Roche

Roche has received FDA 510(k) clearance and CLIA waiver for its cobas liat STI multiplex assay panels, enabling rapid diagnosis of multiple sexually transmitted infections (STIs) in decentralized healthcare settings. The tests will be available in the U.S. in the coming months, followed by CE mark commercialization.

The new panels include tests for chlamydia and gonorrhea (CT/NG) and a three-pathogen panel adding Mycoplasma genitalium (CT/NG/MG). Using PCR technology, the tests provide results in 20 minutes, allowing healthcare providers to diagnose and determine treatment during a single visit.

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

The approval is particularly significant given that over 1 million people acquire curable STIs daily worldwide among ages 15-49, with most cases being asymptomatic. These infections, if untreated, can lead to serious reproductive health complications including pelvic inflammatory disease, infertility, and increased HIV infection risk.

The CLIA waiver means the tests can be performed in various near-patient settings such as urgent care centers, retail clinics, and community health venues with minimal training required. The cobas liat system is a closed system that reduces contamination risks and connects to Roche’s infinity edge platform for remote updates and troubleshooting.

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