BD receives FDA 510(k) clearance for high-throughput diagnostic test for infectious vaginitis 

March 16, 2023 – BD announced that it has received 510(k) clearance from the 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 the first microbiome-based polymerase chain reaction 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. 

If a test is positive for VVC, the BD Vaginal Panel is the only FDA-cleared Nucleic Acid Amplification Test 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 is the only high-throughput, fully integrated preanalytical and analytical system on the market, providing access to critical women’s health and STI testing by enhancing both laboratory operations and patient management with advanced molecular diagnostic capabilities. 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. 

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