Swiss biotech MNC Roche has received CE mark approval for its diagnostic test designed to pinpoint the bacteria and yeast behind bacterial vaginosis (BV) and candida vaginitis (CV) in symptomatic patients.
Samples are collected using Roche’s proprietary cobas PCR Media tube, as per the company.
Traditionally, clinicians rely on microscopy, pH testing, and clinical observation to diagnose BV and CV—methods that are often inaccurate and can delay treatment or lead to unsuitable therapies. Roche says its new 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.”
BV affects roughly 25% of women of reproductive age, while up to 75% experience CV at least once in their lifetime. Both conditions are major drivers of doctor visits, causing symptoms such as itching, burning, discharge, and irritation, and are associated with an increased risk of sexually transmitted infections.
The global sexual health market is valued at CHF 1.1 billion, growing at 11% annually, with vaginitis representing the fastest-growing segment at 26% per year.
The cobas BV/CV assay strengthens Roche Diagnostics’ sexual health portfolio, enabling simultaneous testing for BV, CV, and a broad range of STIs—including Chlamydia, Gonorrhoea, Trichomonas, and Mycoplasma genitalium—using the same sample.
