FDA clears a bioMérieux vaginitis test that gives results in about 20 minutes
The BIOFIRE SPOTFIRE Vaginitis Panel checks one swab for the three most common causes, bacterial vaginosis, yeast and trichomoniasis, in a doctor's office or urgent care. It goes on sale in the US at the start of 2027.
bioMérieux said on Oct 22 that the Food and Drug Administration cleared its BIOFIRE SPOTFIRE Vaginitis (VG) Panel and granted it a CLIA waiver. The test uses PCR, which detects the genetic material of bacteria, yeast and parasites, on one vaginal swab. Results come back in about 20 minutes.
The CLIA waiver changes where the test can run. It lets staff who are not lab professionals use it at the point of care, per bioMérieux. A family practice, urgent care center or OB/GYN office can run the swab on the company’s small SPOTFIRE instrument during the visit instead of sending it out to a lab.
What it checks
Vaginitis is a broad term for three common conditions: bacterial vaginosis, yeast infection and trichomoniasis. The panel reports 8 results from one swab. One is a bacterial vaginosis result, based on an algorithm that reads the balance of several bacteria. Six are Candida yeast species. The last is Trichomonas vaginalis, the parasite behind trichomoniasis.
The swab can be collected by the patient or by a clinician. bioMérieux calls the panel the first rapid molecular vaginitis test. Its announcement gives no accuracy figures and no price.
The diagnosis gap
Most women will have vaginitis at least once, bioMérieux says, citing CDC’s 2021 sexually transmitted infection treatment guidelines. The company says traditional methods are subjective or can miss infections. Only about half of women diagnosed by non molecular testing get appropriate treatment, it says. That figure comes from a randomized study led by Sharon Hillier, published online May 12 in Sexually Transmitted Diseases. That study tested a different company’s PCR test, Xpert Xpress MVP, against usual care.
“The underlying condition is also associated with other health conditions, including pelvic inflammatory disease, cervical cancer, adverse birth outcomes, and secondary infections,” said Charles Cooper, bioMérieux’s chief medical officer.
When it arrives
The panel goes on sale in the US at the beginning of 2027, with a wider global rollout after that, bioMérieux says. The same SPOTFIRE system already runs the company’s respiratory and sore throat panels.
Why it matters
A visit for vaginitis symptoms can now end with a PCR result on all three common causes before the patient leaves the room.
FDA
