Roche's cobas BV/CV Assay receives FDA 510(k) clearance for timely vaginitis diagnosis
Roche announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cobas BV/CV (Bacterial vaginosis/Candida vaginitis) assay. This molecular diagnostic test provides results for both Bacterial vaginosis (BV) and Candida vaginitis (CV) from a single vaginal swab sample. It enables accurate and timely results that can lead to improved patient outcomes and enhanced healthcare efficiencies.
The cobas BV/CV assay, an in vitro diagnostic test, is only available for professional laboratory use based on a clinician's order. The assay utilizes real-time polymerase chain reaction (PCR) technology to accurately 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 test aligns with guidelines from the Centers for Disease Control and Prevention, which does not recommend speciation prior to first-line therapy. Additional Candida speciation or susceptibility testing should be performed if there is persistent or recurrent infection defined by three or more episodes of symptomatic CV within one year or documented treatment failure with first-line therapy.
The sample is collected using a clinician-collected or clinician-instructed, self-collected vaginal swab in cobas PCR Media in a healthcare setting. This enables diagnosis from a single sample that can also be used for broader sexual-health testing with the cobas CT/NG (Chlamydia trachomatis/Neisseria gonorrhoeae) and cobas TV/MG (Trichomonas vaginalis/Mycoplasma genitalium) assays, eliminating the need for additional samples for extended testing.
