Hologic, Inc. (Nasdaq: HOLX) announced today that the FDA has granted clearance for its new Aptima ® BV and Aptima ® CV/TV assays, which provide an accurate and objective method for diagnosing vaginitis, a very common and complex health issue affecting millions of women each year.
About 90 percent of vaginitis is caused by bacterial vaginosis (BV), vulvovaginal candidiasis ( Candida vaginitis, CV, also commonly known as yeast infections), or Trichomonas vaginalis (TV) infections, either individually or in combination. 1,2 In fact, BV is the most common vaginal infection in the United States, affecting an estimated 21 million women ages 14 to 49 years old. 3 Diagnosis can be especially complicated due to the prevalence of co-infections, as approximately 20 to 30 percent of women with BV are co-infected with Candida species. 1 Traditional methods for diagnosing vaginitis (including microscopy, pH determination and Nugent scoring) are highly subjective, leading to misdiagnosis and ineffective treatment. 1,2 When diagnosed using traditional methods and treated based on those subjective results, more than 50 percent of women with vaginitis experience recurring symptoms.
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