Jan. 22, 2025—Roche announced that the FDA has granted 510(k) clearance and CLIA waiver for its Cobas Liat sexually transmitted infection multiplex assay panels. The panels, including tests for chlamydia and gonorrhea and chlamydia, gonorrhea, and Mycoplasma genitalium, enable clinicians to diagnose and differentiate between multiple STIs with a single sample.
The Cobas Liat CT/NG and CT/NG/MG assays run on the Cobas Liat system, which uses gold-standard PCR technology to provide results in 20 minutes or less. The tests will be available in the U.S. market in the coming months, the company said, with commercialization under the CE mark expected to follow.