BD has received 510(k) clearance from the FDA for the BD Vaginal Panel on the BD COR System, a diagnostic test that directly detects the three most common infectious causes of vaginitis using BD's high-throughput molecular diagnostic platform for large laboratories.
Originally granted marketing authorization for the BD MAX System in 2016, the BD Vaginal Panel is the first microbiome-based polymerase chain reaction (PCR) assay that uses a single swab and test to simultaneously detect organisms associated with bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV), and reports a clear positive or negative result for each condition separately. This 510(k) clearance for the BD Vaginal Panel on the BD COR System is the first high-throughput version of the test. Accurate diagnosis of BV, VVC and TV is critical to ensuring appropriate treatment regimens and decreasing the risk of associated complications and resistance to treatment. Using a single test can also help reduce the need for repeat testing unnecessary use of treatments and lower the risk of contracting STIs.
"Most women have a vaginal infection during their lifetime and millions of them receive inadequate treatment," said Nikos Pavlidis, vice president of Diagnostics for BD. "A recent study showed that four out of 10 women didn't receive the appropriate diagnosis and treatment for their vaginitis symptoms after an initial physician visit, which led to four out of 10 women having to schedule a new appointment because of persistent symptoms. The BD Vaginal Panel can help end the cycle of repeat visits, misdiagnosis and ineffective treatment for the millions of women suffering from vaginitis."
If a test is positive for VVC (commonly referred to as a "yeast infection"), the BD Vaginal Panel is the only FDA-cleared Nucleic Acid Amplification Test (NAAT) that provides separate results for C. glabrata and C. krusei — two Candida species that are known to carry resistance to traditional antimicrobials — to ensure proper treatments are prescribed.
The availability of the BD Vaginal Panel on the automated BD COR System in the U.S. reflects BD's commitment to expand the menu of available assays for women's health and other infectious diseases.
The BD Vaginal Panel is the third assay available for use on the BD COR System in the U.S. The first being the BD Onclarity HPV assay (the only FDA-approved HPV test with extended genotyping that can individually identify and report HPV genotypes including HPV 16, 18 and 31, which have the highest contribution to cervical precancer and cancer). The second was the BD CTGCTV2 molecular assay, a single test that detects from one sample the three most prevalent non-viral sexually transmitted infections (STIs) — Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV). These STIs can also have overlapping symptoms making one test to identify all three important for patient care. With the clearance of BD Vaginal Panel on the BD COR™ System, labs can now offer physicians both BD Vaginal Panel and BD CTGCTV2 testing from one swab and one patient collection.
