FDA clears bioMérieux BIOFIRE SPOTFIRE Vaginitis Panel for rapid point-of-care molecular testing

Summary: bioMérieux has received FDA 510(k) clearance and a CLIA waiver for the BIOFIRE SPOTFIRE Vaginitis (VG) Panel, a rapid multiplex PCR test designed to identify common causes of vaginitis at the point of care. The automated test reports eight results from a single vaginal swab in about 20 minutes, supporting diagnosis and treatment decisions within a typical patient visit. Compatible with both self-collected and clinician-collected swabs, the panel will be commercially available in the US from the beginning of 2027.


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.

Results in a typical patient visit

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.

Expanding bioMérieux’s point-of-care offering

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.

* Clinical Laboratory Improvement Amendments (CLIA) waiver allows the BIOFIRE^® SPOTFIRE^® Vaginitis Panel to be used by non-lab professionals at the point of care.

1. Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1. Erratum in: MMWR Morb Mortal Wkly Rep. 2023 Jan 27;72(4):107-108. doi: 10.15585/mmwr.mm7204a5. PMID: 34292926; PMCID: PMC8344968.

2. Hillier SL, Macio I, Gallagher R, Meyn L, Beamer M, Zamborsky T, Campbell T, Bunge K, Wiesenfeld HC. Randomized Study of Usual Care vs Xpert® Xpress MVP at the Point of Care for Accurate Diagnosis and Appropriate Treatment of Vaginal Infections. Sex Transm Dis. 2026 May 12. doi: 10.1097/OLQ.0000000000002343. Epub ahead of print. PMID: 42117698.

3.Bacteria: Bacterial vaginosis - Result informed by an algorithm which assesses the relative abundance of multiple bacteria to provide a binary result. Organisms included are Fannyhessea (Atopobium) vaginae, Bacterial Vaginosis-Associated Bacterium 2 (BVAB2), Lactobacillus crispatus, Lactobacillus gasseri/paragasseri, Lactobacillus jensenii/mulieris, Sneathia sanguinegens/vaginalis (amnii) Yeast: Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Candida dubliniensis Parasite: Trichomonas vaginalis

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