French diagnostics company bioMérieux (Euronext Paris:BIM) announced on Friday that it has submitted a Dual 510(k)/CLIA Waiver application to the US Food and Drug Administration (FDA) for the BIOFIRE SPOTFIRE Vaginitis (VG) Panel, marking its planned expansion into women's and sexual health diagnostics.

The automated multiplex PCR test is designed to detect the most common causes of vaginitis directly at the point of care in about 20 minutes, providing eight results from a single swab to support treatment decisions during a typical patient visit.

Vaginitis is a broad clinical term encompassing conditions such as bacterial vaginosis, vulvovaginal candidiasis, or trichomoniasis, which may arise from infection or an imbalance of the microbiome. Despite its high prevalence, vaginitis is often misdiagnosed or incompletely characterised using traditional methods which can be subjective or lack sensitivity.

bioMérieux said the panel extends its BIOFIRE SPOTFIRE point-of-care portfolio, which already includes tests for respiratory and sore throat infections on the same platform.

Following the US submission, bioMérieux also expects to seek Class C Near Patient Test CE marking for the BIOFIRE SPOTFIRE Vaginitis Panel under the European Union's In Vitro Diagnostic Regulation.