July 29, 2026–Roche received FDA 510(k) clearance for its Cobas BV/CV assay. The molecular diagnostic test provides results for bacterial vaginosis and Candida vaginitis from a single vaginal swab sample. The assay uses real-time polymerase chain reaction 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. It also detects Candida species associated with CV, including C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis, and C. dubliniensis. The sample is collected using a clinician-collected or clinician-instructed, self-collected vaginal swab in Cobas PCR media in a health care setting and runs on the Cobas 6800/8800 systems. The test is only available for professional laboratory use based on a clinician’s order.