Roche wins FDA clearance for vaginitis PCR diagnostic test

Roche (SIX: RO, ROG; OTCQX: RHHBY) has received FDA 510(k) clearance for its cobas® BV/CV assay, a molecular diagnostic test designed to detect bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab sample.

The test uses real-time polymerase chain reaction (PCR) technology to identify DNA targets associated with BV, including Gardnerella vaginalis, Atopobium vaginae and Lactobacillus spp., as well as multiple Candida species linked to CV. Samples can be collected by a clinician or self-collected under clinician instruction using cobas® PCR Media in a healthcare setting.

The assay is intended for professional laboratory use only, based on a clinician's order. It runs on the cobas® 6800/8800 systems and can be used alongside existing cobas® assays for chlamydia, gonorrhea, trichomoniasis and mycoplasma, allowing concurrent testing from a single sample. Roche said it plans to add the cobas® 5800 system through the FDA's Reagent Replacement and Instrument Family Policy, with a commercial launch expected later in 2026.

Vaginitis is among the most common reasons women seek medical care, with BV affecting approximately 27% of women of reproductive age in North America, according to a cited study. Up to 75% of women experience CV at least once in their lifetime, according to Centers for Disease Control and Prevention data referenced in the press release. Traditional diagnostic methods such as microscopy and pH testing have been associated with misdiagnosis rates of close to 50%, according to cited published research.

"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 of Roche Diagnostics North America.

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