BioMérieux submitted a rapid multiplex PCR vaginitis panel to the FDA, seeking dual 510(k) clearance and a CLIA waiver for point-of-care use. The assay, BioFire SpotFire Vaginitis Panel (VG), is designed to produce results from a single vaginal swab within about 20 minutes. The panel targets multiple common causes of vaginitis, including bacterial vaginosis-associated bacteria, Candida species, and Trichomonas vaginalis, and reports eight results per sample. BioMérieux says the goal is to expand women’s and sexual health diagnostics with faster pathogen identification to support targeted treatment decisions. If cleared, the test could reduce time-to-appropriate therapy during a single visit, potentially affecting downstream outcomes tied to untreated or mismanaged vaginitis. The submission also shows continued movement toward rapid multiplex molecular diagnostics in high-volume ambulatory settings.