• FDA Clearance of Aptima BV and Aptima CV/TV Molecular Assays Ushers in New Era of Comprehensive and Objective Diagnostic Testing for Vaginitis

    • June 3, 2019
    • Posted By : admin
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    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.

    “Vaginitis is one of the most common reasons women visit a healthcare provider, and Hologic’s new molecular assays have the potential to transform how these infections are diagnosed in that very first appointment”

    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.1

    “Vaginitis is one of the most common reasons women visit a healthcare provider, and Hologic’s new molecular assays have the potential to transform how these infections are diagnosed in that very first appointment,” says Dr. Edward Evantash, an OB-GYN who is medical director and vice president of medical affairs at Hologic. “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.”

    Unfortunately, many women self-diagnose and self-treat before visiting a healthcare provider, assuming that abnormal vaginal discharge, itching or irritation is due to a simple yeast infection. When BV or TV are left untreated or not properly treated, these infections can put women at risk for a wide variety of complications, including an increased chance of getting a sexually transmitted infection (STI) such as chlamydia or HIV, pelvic inflammatory disease, and pregnancy-related risks including premature delivery, low birth weight and infertility.1,2

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