Roche wins FDA clearance for vaginitis PCR diagnostic test

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Go back to Roche wins FDA clearance for vaginitis PCR diagnostic test

Roche receives FDA clearance for the cobas® BV/CV assay, enabling fast and highly accurate vaginitis diagnosis

July 24, 2026 8:30 AM EDT

The new PCR test uses clinician-collected or clinician-instructed, self-collected vaginal swab specimens to simultaneously detect organisms associated with Bacterial vaginosis (BV) and Candida vaginitis (CV).This molecular assay can help improve diagnostic accuracy for symptomatic women affected by vaginitis, compared to traditional methods.¹The assay expands the sexual-health testing menu on the cobas® 6800/8800 systems, enabling a broad-range of testing from a single... More