bioMérieux receives Dual 510(k) Clearance and CLIA Waiver from the FDA for the BIOFIRE® SPOTFIRE® Vaginitis Panel to Advance Women’s Health with Rapid Molecular Diagnostics

Marcy-l’Étoile (France), October 22, 2026 – bioMérieux, a world leader in the field of in vitro diagnostics, today announced that its BIOFIRE^® SPOTFIRE^® Vaginitis (VG) Panel has received Dual 510(k) Clearance and CLIA Waiver* from the U.S. Food and Drug Administration (FDA). This automated, multiplex polymerase chain reaction (PCR) test can simultaneously detect the most common causes of vaginitis in about 20 minutes, directly at the point of care on the BIOFIRE^® SPOTFIRE^® System, bringing rapid and accurate diagnostics closer to patients.

Most women will experience an episode of vaginitis during their lifetime, often associated with a range of painful symptoms¹. Vaginitis is a broad clinical term encompassing conditions such as bacterial vaginosis, vulvovaginal candidiasis, or trichomoniasis, which may arise from an imbalance of the microbiome or infection. Despite its high prevalence, vaginitis is often misdiagnosed or incompletely characterized using traditional methods that are subjective or may lack sensitivity. Only about half of women diagnosed with vaginitis by non-molecular testing receive appropriate treatment².

The BIOFIRE^® SPOTFIRE^® Vaginitis (VG) Panel is the first rapid molecular vaginitis test and aims to support timely treatment decisions and deliver a clear and accurate diagnostic experience, which is associated with overall improved patient management². The BIOFIRE^® SPOTFIRE^® Vaginitis (VG) Panel reports 8 results with one swab, including bacterial vaginosis, yeast, and parasite pathogens,³ in about 20 minutes, to align with a typical patient visit. The BIOFIRE^® SPOTFIRE^® Vaginitis (VG) Panel can be run with both self-collected and clinician-collected vaginal swabs, providing flexible options to address the unique needs of different patients and healthcare settings. This approach enables healthcare professionals to deliver rapid results and make treatment decisions during a patient visit.

“Not only are the symptoms of vaginitis disruptive and painful, but the underlying condition is also associated with other health conditions, including pelvic inflammatory disease, cervical cancer, adverse birth outcomes, and secondary infections. bioMérieux is proud to bring a better diagnostic solution to patients, which can guide healthcare practitioners in prescribing targeted treatment to more quickly alleviate symptoms and potentially reduce the risk of other negative health consequences,” stated Dr. Charles K. Cooper, Executive Vice President, Chief Medical Officer, bioMérieux.

“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. With the FDA clearance of the BIOFIRE^®SPOTFIRE^® Vaginitis (VG) Panel, bioMérieux is addressing this gap by bringing fast, syndromic molecular testing directly to the point-of-care setting, enabling healthcare practitioners to move from uncertainty to actionable answers within a single patient visit. This is not just an incremental improvement, it’s a strategic step toward closing a long-standing diagnostics gap in women’s health, fundamentally improving both clinical decision-making and the patient experience,” added Jennifer Zinn, Executive Vice President, Clinical Operations, at bioMérieux.

The BIOFIRE^® SPOTFIRE^® Vaginitis (VG) Panel represents a meaningful expansion of bioMérieux’s innovative point-of-care portfolio, which already includes panels for respiratory and sore throat infections on the BIOFIRE^® SPOTFIRE^®System. The system is an easy-to-use, modular instrument with a small footprint designed to fit in any healthcare setting, including family care practices, urgent care settings, and obstetrician/gynecologist (OB/GYN) offices.

The BIOFIRE^® SPOTFIRE^® Vaginitis (VG) Panel will be commercially available at the beginning of 2027 in the United States, followed by an extended rollout worldwide.