The cobas BV/CV assay aims to improve diagnostic accuracy over traditional microscopy and pH testing methods for symptomatic patients.
Roche announced CE Mark approval for its cobas BV/CV (bacterial vaginosis/candida vaginitis) assay, designed to identify specific bacteria and yeast responsible for BV and CV in vaginal samples from symptomatic patients.
The PCR-based test uses Roche’s proprietary cobas PCR Media tube for sample collection and runs on the company’s cobas 5800/6800/8800 systems. The assay targets common causes of vaginitis that can be challenging to diagnose accurately with conventional methods.
“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,” says Matt Sause, CEO of Roche Diagnostics, in a release. “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.”
Addressing Diagnostic Challenges
Current diagnostic approaches for BV and CV typically rely on microscopy, pH testing, and clinical observation. These methods can produce inaccurate results due to the non-specific nature of symptoms, potentially leading to treatment delays or inappropriate therapies.
Bacterial vaginosis affects approximately 25% of women of reproductive age, while up to 75% of women experience candida vaginitis at least once during their lifetime, according to Roche. Vaginal symptoms represent one of the most common reasons women seek medical care annually.
The conditions cause symptoms including itching, burning, discharge, and irritation. Both BV and CV infections are associated with increased risk of sexually transmitted infections.
Market and Portfolio Integration
The new assay expands Roche Diagnostics’ sexual health testing portfolio. Labs can test for BV and CV alongside sexually transmitted infections including chlamydia, gonorrhea, trichomonas, and Mycoplasma genitalium using the same sample type.
This integrated approach supports workflows in sexual health clinics, hospitals, and laboratories by enabling multiple tests from a single specimen collection. The cobas BV/CV assay is now available in countries accepting the CE Mark.
