Roche has announced the launch of a new PCR-based diagnostic test designed to improve the accuracy and speed of diagnosing vaginitis in countries that recognise the CE Mark. The cobas® BV/CV (Bacterial Vaginosis/Candida Vaginitis) assay identifies bacteria linked to bacterial vaginosis and yeast associated with candida vaginitis, conditions that affect millions of women each year.
The company confirmed the CE Mark for the test on 9 December 2025, stating that it can analyse vaginal samples taken from symptomatic patients using the cobas PCR Media proprietary tube. The test is intended to reduce uncertainty in diagnosing BV and CV, which often present with non-specific symptoms that clinicians traditionally assess through microscopy, pH testing and general observation. These older methods can lead to imprecise diagnoses, delaying appropriate treatment or prompting the use of unsuitable therapies.
Roche said the new assay offers a more accurate approach by detecting specific bacteria and yeast responsible for infection. It also enables healthcare providers to use a single vaginal swab for wider sexual health screening, avoiding the need for additional samples.
Matt Sause, CEO of Roche Diagnostics, said: “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. 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.”
Bacterial vaginosis affects around 25% of women of reproductive age, while up to 75% experience candida vaginitis at least once. Both conditions can cause discomfort, including itching, burning and irritation, and are associated with a higher risk of contracting sexually transmitted infections. Diagnosis can be complicated as symptoms overlap and standard testing methods lack precision.
The global sexual health market is valued at CHF 1.1 billion, with vaginitis representing the fastest-growing segment at a yearly growth rate of 26%. Roche said the cobas BV/CV assay will expand its sexual health portfolio by allowing BV and CV testing alongside screening for Chlamydia, Gonorrhoea, Trichomonas and Mycoplasma genitalium. The assay is compatible with the company’s cobas 5800/6800/8800 systems, enabling more efficient workflows for hospitals, laboratories and sexual health clinics.
The new assay is now available in markets that accept the CE Mark.
