Molecular Vaginitis Panel Gains FDA Clearance and CLIA Waiver for Point-of-Care Use

Vaginitis affects most women at least once in their lifetime and can cause painful, disruptive symptoms. Common causes include bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis, reflecting microbiome imbalance or infection. Diagnosing these conditions can be challenging when traditional methods are subjective or lack sensitivity. To support more reliable assessment, a newly cleared point-of-care molecular test provides multiple vaginitis results from a single vaginal swab in about 20 minutes.

bioMérieux’s BioFire Spotfire Vaginitis (VG) Panel has received both 510(k) clearance and a CLIA waiver from the U.S. Food and Drug Administration (FDA). The automated multiplex PCR assay runs on the BioFire Spotfire Vaginitis System, bringing molecular vaginitis testing to the point of care. With the CLIA waiver, non-laboratory professionals can perform the test in point-of-care settings.

Image: The automated multiplex PCR assay runs on the BioFire Spotfire Vaginitis System, bringing molecular vaginitis testing to the point of care (Photo courtesy of bioMérieux)

The panel reports eight results from a single vaginal swab, covering bacterial vaginosis, yeast pathogens, and the parasite Trichomonas vaginalis. For bacterial vaginosis, the result is informed by an algorithm that assesses the relative abundance of multiple bacteria and provides a binary result. The yeast component includes Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and Candida dubliniensis.

The assay can be run with self-collected or clinician-collected vaginal swabs, offering options for different patients and healthcare settings. Only about half of women diagnosed with vaginitis by non-molecular testing receive appropriate treatment. The test is intended to provide rapid results during a typical patient visit, supporting treatment decisions during the same encounter.

The BioFire SpotfireVaginitis (VG) Panel expands bioMérieux’s point-of-care portfolio, which includes panels for respiratory and sore throat infections on the same system. The modular instrument has a small footprint and is designed for healthcare settings including family care practices, urgent care sites, and obstetrician/gynecologist offices. The panel is planned to be commercially available in the United States at the beginning of 2027, followed by an extended worldwide rollout.