FDA grants 510(k) clearance to Roche's cobas BV/CV assay

Roche received FDA 510(k) clearance for its cobas BV/CV (Bacterial vaginosis/Candida vaginitis) assay, a molecular diagnostic test that returns results for both conditions from a single vaginal swab. The assay is intended for professional laboratory use, based on a clinician's order, the company noted in a July 24, 2026 news release.¹

The test uses real-time polymerase chain reaction technology to identify the specific bacteria and yeast species that are responsible for BV and CV in symptomatic patients. Roche stated that the assay is designed to support faster, more accurate diagnosis than syndromic evaluation alone, with the goal of improving both patient outcomes and laboratory efficiency.¹

BV and CV are among the most common causes of vaginal symptoms in the United States, and both conditions can present with overlapping symptoms that complicate clinical diagnosis based on history and examination alone.^2,3 The Centers for Disease Control and Prevention (CDC) has noted that the majority of women will experience at least 1 vaginal infection during their lifetime, underscoring the potential clinical utility of a single-swab, dual-target molecular test.^2,3

Key data and test specifications

• Detects DNA targets for BV-associated organisms, including Gardnerella vaginalis, Atopobium vaginae, and Lactobacillus spp.¹
• Detects Candida species associated with CV, including C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, and C. dubliniensis
• Sample collected via clinician-collected or clinician-instructed self-collected vaginal swab in cobas PCR Media, in a health care setting
• Same sample can be used for extended testing with the cobas CT/NG (Chlamydia trachomatis/Neisseria gonorrhoeae) and cobas TV/MG (Trichomonas vaginalis/Mycoplasma genitalium) assays

Molecular testing aligns with current CDC treatment guidance

Roche stated that the cobas BV/CV assay's diagnostic approach aligns with CDC's STI Treatment Guidelines (2021, most recently reviewed 2025), which do not call for Candida speciation before first-line therapy is initiated.² Additional speciation or susceptibility testing becomes relevant only in cases of persistent or recurrent CV, specifically 3 or more symptomatic episodes in a year or a documented failure of first-line treatment.³ This distinction is intended to help clinicians reserve more detailed molecular workups for the patients most likely to benefit from them.

Single-swab workflow may reduce burden of overlapping vaginal symptoms

Because BV and CV frequently present with similar symptoms, including discharge, odor, and irritation, syndromic misdiagnosis is common in clinical practice. A single swab capable of resolving both conditions, and compatible with additional sexually transmitted infection testing panels, is positioned to streamline diagnostic workflows without requiring repeat sample collection.¹

“Roche plans to add the cobas 5800 system to the assay via the FDA's Reagent Replacement and Instrument Family Policy. The commercial launch is expected later this year,” the company stated.

References:

1. Roche. Roche receives FDA 510(k) clearance for cobas BV/CV assay. Press release. July 24, 2026.
2. Centers for Disease Control and Prevention. Bacterial vaginosis. STI Treatment Guidelines, 2021 (reviewed 2025). Accessed July 2026. https://www.cdc.gov/std/treatment-guidelines/bv.htm
3. Centers for Disease Control and Prevention. Vulvovaginal candidiasis. STI Treatment Guidelines, 2021 (reviewed 2025). Accessed July 2026. https://www.cdc.gov/std/treatment-guidelines/candidiasis.htm