Roche Secures CE Mark For Cobas BV/CV Assay, Advancing Accurate Diagnosis Of Vaginitis; Expands Roche’s Sexual Health Portfolio

Roche announced that its cobas® BV/CV assay has received the CE Mark, enabling its use in Europe for accurately detecting bacterial vaginosis (BV) and candida vaginitis (CV). The test identifies the specific bacteria and yeast responsible for these conditions from vaginal samples collected using the cobas PCR Media tube, offering a more reliable alternative to traditional diagnostic methods.

BV and CV often present with non-specific symptoms, and clinicians typically rely on microscopy, pH measurements, and clinical evaluations, approaches that can yield inconsistent or inaccurate results. The new cobas BV/CV assay provides precise, organism-specific results, helping clinicians prescribe the right therapy faster and avoid delays or misdiagnoses. This is particularly significant as BV affects about one in four women of reproductive age, and up to 75% of women experience CV at least once.

“The cobas BV/CV assay protects women from the risks of delayed or incorrect treatment, leading to faster relief from symptoms and a reduced likelihood of serious future complications,” said Matt Sause, CEO of Roche Diagnostics. “At the same time, it improves efficiency for healthcare services by accurately identifying the most common causes of inflammation or infection in a single test.”

Vaginal symptoms account for millions of clinical visits annually, yet conventional diagnostic tools have limited precision. BV and CV not only cause discomfort, including itching, burning, irritation, and discharge, but also increase susceptibility to sexually transmitted infections. Accurate testing therefore plays a critical role in both symptom relief and broader sexual health management.

The new assay expands Roche Diagnostics’ sexual health portfolio and aligns with a global sexual health diagnostics market valued at CHF 1.1 billion, growing at 11% annually. With vaginitis as the fastest-growing segment at 26% per year, the ability to test for BV and CV alongside STIs such as Chlamydia, Gonorrhoea, Trichomonas, and Mycoplasma genitalium on the cobas 5800/6800/8800 systems offers significant workflow efficiencies for clinics, hospitals, and laboratories. The cobas BV/CV assay is now available in all markets that recognize the CE Mark.