The automated PCR test provides results in 20 minutes to help clinicians diagnose common causes of vaginitis during a patient visit.
bioMérieux submitted a Dual 510(k)/Clinical Laboratory Improvement Amendments waiver application to the Food and Drug Administration (FDA) for its Biofire Spotfire vaginitis panel.
The automated, multiplex polymerase chain reaction test is designed to detect common causes of vaginitis in approximately 20 minutes at the point of care. The submission marks the company’s first expansion into the women’s and sexual health diagnostic market.
Vaginitis encompasses conditions such as bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis. While the condition is prevalent, it is often misdiagnosed or incompletely characterized when using traditional methods that may lack sensitivity, according to bioMérieux. Data from the company indicates that only about half of women diagnosed with vaginitis through non-molecular testing receive appropriate treatment.
The Biofire Spotfire vaginitis panel reports eight results from a single swab, including bacterial vaginosis, yeast, and parasite pathogens. The 20-minute turnaround time is intended to align with a typical patient visit to support timely treatment decisions.
“Not only are the symptoms of vaginitis disruptive and painful, the underlying condition is also associated with other health conditions, including pelvic inflammatory disease, cervical cancer, adverse birth outcomes, and secondary infections,” says Charles K Cooper, executive vice president, chief medical officer, bioMérieux, in a release.
The panel runs on the Biofire Spotfire system, a modular instrument designed for various healthcare settings that already supports panels for respiratory and sore throat infections.
“Today, there is a clear and persistent gap in vaginitis diagnostics—between the need for accurate, comprehensive testing and the reality of delayed or incomplete results in clinical practice,” says Jennifer Zinn, executive vice president, clinical operations, bioMérieux, in a release.
With the submission to the FDA, the company aims to expand syndromic testing beyond traditional clinical laboratories and into point-of-care settings. Following the US submission, bioMérieux also expects to submit the panel for CE marking under the In Vitro Diagnostic Regulation in the European Union.
