Roche cobas BV/CV vaginitis test FDA-cleared

Roche has received FDA 510(k) clearance for the cobas BV/CV assay, which detects bacterial vaginosis and Candida vaginitis from a single vaginal swab using real-time PCR, promising more accurate diagnoses than traditional methods. The test can be run on the cobas platform alongside other sexual-health assays and is intended for professional laboratory use, aiming to reduce misdiagnosis and speed appropriate treatment.