Roche receives FDA clearance with CLIA waiver for cobas liat molecular tests to aid in diagnosing sexually transmitted infections at the point of care
Jan. 24, 2025
Roche announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels.
These panels, including tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and Mycoplasma genitalium (CT/NG/MG), enable clinicians to diagnose and differentiate between multiple STIs with a single sample. These tests will be exclusively available in the U.S. market in the coming months, with commercialization under CE mark expected to follow shortly.
