• The new PCR test aids in the diagnosis of infectious causes of vaginitis through the detection of bacteria associated with bacterial vaginosis and yeast associated with candida vaginitis. 
• The test will help improve diagnostic accuracy for millions of women affected by vaginitis annually, delivering more accurate and specific results.
• This test offers faster diagnosis by using a single vaginal swab for broader sexual health testing, eliminating the need for an additional sample.

Roche announced today the CE Mark for its cobas® BV/CV (Bacterial Vaginosis/Candida Vaginitis) assay to accurately identify specific bacteria and yeast responsible for BV and CV in vaginal samples from symptomatic patients collected using the cobas PCR Media proprietary tube.

Clinicians typically rely on microscopy, pH testing, and clinical observation to diagnose BV and CV, which present with non-specific symptoms.

These methods can deliver inaccurate results, leading to delays in treatment or prescription of unsuitable therapies. The cobas BV/CV assay resolves this challenge by delivering accurate and specific results, allowing healthcare professionals to deliver targeted therapies to patients more quickly. 

“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.”

Bacterial vaginosis impacts approximately 25% of women of reproductive age, while up to 75% of women experience candida vaginitis at least once in their lifetime. Vaginal symptoms are one of the most common reasons women visit the doctor each year.

Diagnosis of these conditions can be challenging as symptoms are often non-specific, and traditional testing methods, such as microscopy, lack precision. Causing uncomfortable and sometimes distressing symptoms such as itching, burning, discharge, and irritation,  BV and CV infections are also associated with an increased risk of having a sexually transmitted infection (STI).

The global sexual health market segment is valued at CHF 1.1 bn, with an annual growth rate of 11%. Of this market segment, vaginitis is the primary growth driver with a yearly growth rate of 26%.

The cobas BV/CV assay further expands Roche Diagnostics’ established sexual health portfolio. By enabling testing for BV and CV alongside a broad range of sexually transmitted infections, including Chlamydia, Gonorrhoea, Trichomonas, and Mycoplasma genitalium, using the same sample, the assay enhances the capabilities of the cobas 5800/6800/8800 systems.

This streamlined approach supports sexual health clinics, hospitals, and laboratories by delivering faster, more efficient workflows, while also ensuring that patients benefit from accurate diagnosis and timely care. 

The cobas BV/CV assay is now available in countries accepting the CE Mark.

09.12.2025.