New Vaginitis Assays Approved by the FDA

The US Food and Drug Administration (FDA) has cleared a pair of new assays designed to diagnose bacterial vaginosis (BV), candida vaginitis (CV) and Trichomonas vaginalis (TV).

The Aptima BV and Aptima CV/TV assays from Hologic intend to improve on the accuracy standards set by traditional vaginitis assay methods such as microscopy, pH determination, and Nugent scoring.

According to Hologic, previous diagnosis methods have proven to be highly subjective, and could lead to misdiagnoses and ineffective treatment. The company cited a study showing that more than 50% of women with vaginitis experience recurring symptoms when diagnosed using traditional methods.

Approximately 21 million women aged 14-49 years old in the US are affected by BV annually, with about 20% to 30% experiencing CV co-infection. Untreated or improperly treated BV or TV can put women at risk for complications, including an increased risk of sexually transmitted infections (STI) such as HIV, chlamydia, and pelvic inflammatory disease.

The new assays make 16 marketed in the US by Hologic, who promote molecular-based testing for STIs, hepatitis B and C, HIV, and more. The Aptima Multitest Swab Specimen Collection Kit allows physicians to test up to 7 disease states and infections: BV, TV, CV, Candida glabrata, chlamydia, gonorrhea, and Mycoplasma genitalium.

Vaginitis remains among the most common reasons for a women to visit her healthcare provider, Edward Evantash, MD, and OB-GYN and medical director and vice president of medical affairs at Hologic, said in a statement. The new molecular assays could transform the rate of diagnoses made in that immediate appointment.

“The improved sensitivity and specificity of Hologic’s molecular assays over traditional methods in determining the underlying cause of vaginitis not only means identifying the right infection, but enabling the right treatment and, in turn, reducing the potential for recurrent or persistent infections,” Evantash said.