Roche launches new PCR test to help improve diagnostic accuracy following the CE Mark
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
12 Dec 2025
Roche has announced 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.
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.
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 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.”
The cobas BV/CV assay is now available in countries accepting the CE Mark.
