Medtech company Becton, Dickinson and Company has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its BD Vaginal Panel on the BD COR System. The comprehensive diagnostic test detects the three most common infectious causes of vaginitis using BD’s molecular diagnostic platform for large laboratories.
The BD Vaginal Panel is a microbiome-based polymerase chain reaction (PCR) assay that uses a single swab and test to simultaneously detect bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis (TV). The test reports a clear positive or negative result for each condition separately. Accurate diagnosis of BV, VVC, and TV is crucial for ensuring appropriate treatment regimens and decreasing the risk of associated complications and resistance to treatment.
The BD Vaginal Panel is the first high-throughput version of the test and is available on the automated BD COR System in the U.S. According to the company 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.
“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.”