bioMérieux Submits FDA Application for Rapid Vaginitis Test
On Friday, bioMérieux submitted a combined 510(k) authorization and CLIA waiver application to the FDA for its Biofire Spotfire Vaginitis Panel, a rapid molecular diagnostic designed to identify the causes of vaginitis in twenty minutes. This move marks the Lyon-based group's entry into the field of women's and sexual health diagnostics.
A Rapid Molecular Test for Vaginitis Diagnosis
The Biofire Spotfire VG Panel test can identify eight microorganisms responsible for infection (including bacterial vaginosis, several species of Candida, and Trichomonas vaginalis) from a single swab in about twenty minutes, which is the duration of a standard medical consultation. This automated multiplex PCR solution for decentralized biology aims to be used directly at the patient's bedside (point of care), outside of traditional laboratories.
According to bioMérieux, vaginitis is often misdiagnosed with traditional, subjective methods or those lacking sensitivity. The company emphasizes that only about half of the women diagnosed with vaginitis through non-molecular tests receive appropriate treatment.
A First Step in a New Strategic Direction
This FDA authorization request represents bioMérieux's first step into the field of diagnostics in women's and sexual health. It expands the existing portfolio of innovative solutions in decentralized biology, which already includes tests for respiratory infections and sore throats using the same Biofire Spotfire system.
bioMérieux also indicates that the Biofire Spotfire VG Panel test is expected to be submitted for CE marking as a Class C near-patient diagnostic test, in accordance with the IVDR regulation in the European Union. The product is currently not available for sale and is awaiting FDA authorization.
