The US Food and Drug Administration has granted 510(k) clearance to Roche’s cobas BV/CV assay, a molecular diagnostic test designed to detect bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab sample, according to a company announcement.
The assay uses real-time polymerase chain reaction technology and can be performed using clinician-collected or clinician-instructed self-collected vaginal swab specimens collected in a health care setting. Roche stated that the test is intended for professional laboratory use based on a clinician’s order.
- Drug/device: cobas® BV/CV assay (PCR-based IVD)
- Manufacturer: Roche Diagnostics
- Indication: Detection of BV and CV organisms in symptomatic women
- Regulatory action: FDA 510(k) clearance
- Platform: cobas® 6800/8800 systems
- BV targets: G. vaginalis, A. vaginae, Lactobacillus spp.
- CV targets: 6 Candida species including C. albicans
- Sample type: Vaginal swab, clinician- or self-collected
- Key safety signals: Not reported in press release
- Commercial launch: Expected later in 2026
What does the cobas BV/CV assay detect?
The cobas BV/CV assay detects DNA targets for organisms associated with BV, including Gardnerella vaginalis, Atopobium vaginae, and Lactobacillus species. It also detects Candida species associated with CV, including C albicans, C glabrata, C krusei, C parapsilosis, C tropicalis, and C dubliniensis.
The test is designed for use in symptomatic patients and provides results for both BV and CV from the same vaginal swab specimen. Roche stated that the assay expands the sexual health testing menu on the cobas 6800/8800 systems and allows broader testing from a single sample.
Why is this clinically relevant?
Vaginitis is among the most common reasons women seek care, and BV and CV are 2 of the most frequent infectious causes. Symptoms can overlap and may include itching, burning, discharge, and irritation, making diagnosis challenging in routine practice.
Traditional diagnostic approaches, including microscopy, vaginal pH testing, and clinical observation, may lack precision. Roche cited data suggesting misdiagnosis of vaginitis is close to 50%, which can increase the risk of inappropriate treatment, persistent symptoms, and recurrence.
“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,” Brad Moore, president and CEO of Roche Diagnostics North America, said in the announcement.
How could this affect primary care workflow?
For primary care clinicians, the clearance is relevant because vaginitis is frequently evaluated outside specialty gynecology settings. A molecular assay that identifies BV- and CV-associated organisms from a single sample may help clinicians move beyond empiric treatment when symptoms are nonspecific or recurrent.
Roche also noted that the same sample can be used for broader sexual health testing with the cobas CT/NG assay for Chlamydia trachomatis and Neisseria gonorrhoeae and the cobas TV/MG assay for Trichomonas vaginalis and Mycoplasma genitalium. This may support more efficient testing workflows when clinicians are evaluating vaginal symptoms and sexually transmitted infection risk at the same visit.
The company stated that the assay aligns with Centers for Disease Control and Prevention guidance that does not recommend Candida speciation before first-line therapy. Additional Candida speciation or susceptibility testing should be performed in patients with persistent or recurrent infection, defined as 3 or more episodes of symptomatic CV within 1 year, or documented treatment failure with first-line therapy.
Bacterial vaginosis affects approximately 27% of women of reproductive age in North America, according to the announcement, and up to 75% of women experience Candida vaginitis at least once in their lifetime. BV and CV also have broader reproductive and sexual health implications because vaginitis has been associated with increased risk of sexually transmitted infection acquisition.
Roche said the cobas BV/CV assay is expected to launch commercially later this year. The company also plans to add the cobas 5800 system to the assay through the FDA’s Reagent Replacement and Instrument Family Policy.
Reference
- Roche. Roche receives FDA clearance for the cobas BV/CV assay, enabling fast and highly accurate vaginitis diagnosis. Published July 24, 2026. Accessed July 24, 2026. https://www.prnewswire.com/news-releases/roche-receives-fda-clearance-for-the-cobas-bvcv-assay-enabling-fast-and-highly-accurate-vaginitis-diagnosis-302833857.html
