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

INDIANAPOLIS, July 24, 2026 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cobas® BV/CV (Bacterial vaginosis/Candida vaginitis) assay. This molecular diagnostic test provides results for both Bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab sample. It enables accurate and timely results that can lead to improved patient outcomes and enhanced healthcare efficiencies.

Vaginitis is one of the most common reasons women visit a healthcare provider,2 with Bacterial vaginosis (BV) and Candida vaginitis (CV) being two of the most frequent causes of infection.Clinicians have traditionally relied on less precise methods such as microscopy, pH testing and clinical observation to diagnose these conditions, yet these methods lack precision.4,5,6 Accurate vaginitis diagnosis is a cornerstone of effective treatment, yet misdiagnosis of this condition is close to 50%, raising the risk of recurrence.7

“Compared to traditional methods, the cobas® BV/CV test can help improve diagnostic accuracy for women affected by vaginitis, addressing a critical need in women’s health,” said Brad Moore, President and CEO, Roche Diagnostics North America. “By expanding our sexual-health portfolio to include comprehensive results for the most common conditions from a single sample, we can streamline care to help patients receive the right treatment faster.”

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