GEN

Roche’s Cobas Test for Chlamydia and Gonorrhea Granted 510(k) Clearance in U.S.

Multiplex PCR Assay for cobas 4800 system uses self-collected male urine and vaginal swab samples. FDA granted 510(k) clearance for Roche’s cobas® CT/NG Test for detecting Chlamydia trachomatis (CT) ...
FierceBiotech

Roche nets clearances for sexually transmitted infection tests at the point of care

Roche has obtained U.S. government green lights allowing its point-of-care testing system to be used to screen for multiple sexually transmitted infections from a single sample. The company’s cobas ...
BioWorld

Roche receives FDA approval for STI point-of-care tests

Roche AG secured U.S. FDA 510(k) clearance for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The tests, which also received a Clinical Laboratory Improvement Amendments ...

OraSure Technologies, Inc. Announces FDA Clearance that Expands Patient‑Friendly Access to Testing for Sexually Transmitted Infections

Pee™•Dx Urine Collection Kit for at-home sample collection with Roche’s cobas® molecular lab testing equipmentBETHLEHEM, Pa., June 11, 2026 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (“OraSure”) ...