Roche announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance with a CLIA waiver for sets of its cobas liat sexually transmitted infection (STI) multiplex assay panels.
The FDA-cleared molecular test panels include point-of-care CLIA-waived tests for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), as well as CT, NG, and Mycoplasma genitalium (MG), the company said, adding that the tests enable clinicians to diagnose and differentiate between multiple STIs using a single sample.
Cobas liat STI multiplex panels rely on polymerase chain reaction (PCR) analysis in a closed-system compact analyzer, according to Roche. The STI tests complement existing tests for respiratory tract infections, group A Streptococcus and Clostridioides difficile.
CT and NG are among the most prevalent STIs, Roche noted. Diagnosis is challenging, however, because common STIs often present overlapping symptoms and can frequently be asymptomatic.
The STI panels support testing in urgent care centers, retail clinics, and community health centers and will be available in the U.S. in the coming months, Roche said. Commercialization under the European Union CE Mark is expected to follow, the company added.
