BD receives FDA 510(k) clearance for high-throughput diagnostic test for infectious vaginitis
BD (Becton, Dickinson and Company) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD Vaginal Panel on the BD COR System, a comprehensive 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 one of 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.
If a test is positive for VVC (commonly referred to as a "yeast infection"), the BD Vaginal Panel is an 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 BD COR System allows 1,700 specimens to be loaded at a time, with onboard capacity for reagents and samples that provide more than eight hours of unimpeded system processing. The system is capable of delivering nearly 2,000 sample results in 24 hours, eliminating multiple manual interactions per shift that were traditionally required.
