BD Vaginal Panel receives FDA 510(k) clearance

The FDA has given 510(k) clearance to Becton, Dickinson and Company’s BD Vaginal Panel on the BD COR system.

The BD Vaginal Panel is a diagnostic test using a high-throughput molecular platform to detect the 3 most common infectious causes of vaginitis. It is the first microbiome-based polymerase chain reaction assay testing for bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV) through a single swab test.

According to Nikos Pavlidis, vice president of Diagnostics for BD, millions of women do not receive adequate treatment for vaginal infections. To ensure proper treatments of BV, VVC, and TV, an accurate diagnosis is necessary. This also reduces the risk of complications and treatment resistance.

Testing for the 3 infectious causes in a single test allows repeat testing to be avoided and lowers the risk of contracting sexually transmitted infections (STIs). Repeat visits, misdiagnosis, and ineffective treatment may also be avoided using the BD Vaginal Panel.

The BD Vaginal Panel is also the only Nucleic Acid Amplification Test with FDA clearance to provide separate results for Candida glabrata and Candida krusei in instances of positive VVC tests, also known as yeast infection. These are 2 Candida species with resistance to traditional antimicrobials, requiring specific treatment.

The BD COR System is a preanalytical and analytical system providing access to women’s health and STI testing. It can provide over 2000 sample results in 24 hours, making multiple manual interactions no longer necessary.

The first assay on the BD COR System available for use in the United States was the BD Onclarity HPV assay, an HPV test able to identify HPV genotypes such as HPV 16, 18, and 31 using extended genotyping. The second was the BD CTGCTV2 molecular assay, able to detect the 3 most common STIs with a single test. The BD Vaginal Panel is the third assay available.

Reference

BD receives FDA 510(k) clearance for first-of-its-kind high-throughput diagnostic test for infectious vaginitis.BioSpace. March 16, 2023. Accessed March 29, 2023. https://www.biospace.com/article/releases/bd-receives-fda-510-k-clearance-for-first-of-its-kind-high-throughput-diagnostic-test-for-infectious-vaginitis/?s=74