Roche has secured US Food and Drug Administration (FDA) clearance for its bacterial vaginosis/candida vaginitis (BV/CV) assay in a market authorisation that will likely streamline patient access to diagnosis for the conditions.
Roche said FDA clearance for the cobas test will help address a critical unmet diagnostic need within the broader women’s health space, highlighting that clinicians have traditionally relied on less precise methods to diagnose BV/CV such as microscopy, pH testing and clinical observation, despite their limited specificity.
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Accurate vaginitis diagnosis is a cornerstone of effective treatment, yet misdiagnosis of this condition is close to 50%, raising the risk of recurrence, Roche stated.
Bacterial vaginosis impacts around 27% of reproductive-aged women in North America, while up to 75% of women experience Candida vaginitis at least once in their lifetime.
As with a CE mark gained in Europe in December 2025, Roche’s cobas BV/CV is only available for professional laboratory use. It deploys PCR technology to identify the specific bacteria and yeast responsible for BV and CV in vaginal samples from symptomatic patients.
The test detects DNA targets for organisms associated with BV, including Gardnerella vaginalis, Atopobium vaginae and Lactobacillus spp, and Candida species associated with CV, including C. albicans, C. glabrata, and C. krusei.
Brad Moore, president and CEO of Roche Diagnostics North America, commented: “Compared to traditional methods, the cobas BV/CV test can help improve diagnostic accuracy for women affected by vaginitis, addressing a critical need in women’s health.
“By expanding our sexual-health portfolio to include comprehensive results for the most common conditions from a single sample, we can streamline care to help patients receive the right treatment faster.”
Roche added that the enablement of concurrent testing for BV and CV complements its other STI tests, including for chlamydia trachomatis, Neisseria gonorrhoeae, trichomonas vaginalis and Mycoplasma genitalium, thereby enhancing the capabilities of other systems in the cobas lineup and assisting sexual health clinics in streamlining their operational workflows.
