Basel, 22 January 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 commercialisation under CE mark expected to follow shortly.

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Roche receives FDA clearance with CLIA waiver for cobas® liat molecular tests to diagnose sexually transmitted infections at the point of care