BioMérieux filed for dual 510(k) clearance and CLIA waiver with the FDA for a rapid, point-of-care vaginitis molecular panel. The company submitted its BioFire SpotFire Vaginitis Panel (VG), designed to detect common causes of vaginitis within 20 minutes at the point of care. The assay reports eight results from a single vaginal swab and includes bacteria associated with bacterial vaginosis, multiple Candida species, and Trichomonas vaginalis. BioMérieux said the program is intended to help guide targeted prescribing during a single visit and reduce downstream risks associated with untreated infections. For women’s health diagnostics, the submission expands BioMérieux’s push into sexual health with a multiplex PCR approach that aims to shorten time-to-treatment decisions in clinical settings.