FDA gives de novo approval for BD’s vaginitis detectorOctober 31, 2016
BD has gotten FDA market authorization for a first-of-its-kind molecular test to detect the most common causes for vaginitis.
As BD explained it its press release on Monday, laboratories and clinicians will now have the ability to use a single test to detect microorganisms responsible for Bacterial Vaginosis (BV), Trichomoniasis (TV) and Vulvovaginal Candidiasis (VVC), also known as a yeast infection, which are the most common infectious causes of vaginitis. The new in vitro diagnostic (IVD) assay is the first multiplex, real-time polymerase chain reaction (PCR) assay authorized by FDA for the diagnosis of both vaginitis and vaginosis in women that exhibit symptoms of vaginal infections, BD noted.
“Vaginitis is highly prevalent, with large gaps in clinical management that improved diagnostics could help address,” said Dr. Mark Martens, MD, FACOG, Chair, Dept. of Obstetrics and Gynecology Jersey Shore University Medical Center, part of the Hackensack Meridian Health. “Traditional methods used to detect vaginitis can be challenging due to the presence of many interfering substances in specimens, the large number of mixed infections, and the subjectivity of these methods. A multiplex microbiome-based real-time PCR assay has the potential to help clinicians improve patient management and help laboratories increase workflow efficiency.”, Dr. Martens further explained.
“With the FDA market authorization of the BD MAX Vaginal and CT/GC/TV Panels, BD is now able to offer clinical laboratories automated PCR tests to aid in the detection and diagnosis of important reproductive and sexually transmitted infections,” said Doug White, vice president and general manager of Molecular Diagnostics and Women’s Health for BD. “The US launch of the BD Max Vaginal Panel signifies BD’s continued commitment to elevating the standard of care for women’s health and sexually transmitted infections.”, he added.
FDA market authorization was granted under a de novo petition, which is a regulatory pathway for novel products that are first-of-a-kind. This represents the second addition to the BD Reproductive and Sexually Transmitted Infections portfolio within the last quarter. In September, BD obtained FDA clearance for the BD MAX CT/GC/TV assay, which provides laboratories the ability to detect Chlamydia, Gonorrhea and Trichomoniasis from a single specimen with one test.