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Becton Dickinson Gets FDA 510(k) Clearance for High-Throughput Vaginitis Test

NEW YORK – Becton Dickinson announced on Thursday that it received 510(k) clearance from the US Food and Drug Administration for a high-throughput assay to detect vaginitis.

The assay, called the BD Vaginal Panel, runs on the firm's BD Cor System and tests for the three most common pathogens that cause vaginitis using a single swab sample.

The vaginitis panel was originally launched in 2016 for use on the BD Max System, but the BD Vaginal Panel assay on the BD Cor is the first high-throughput version of the test, the Franklin Lakes, New Jersey-based firm noted in a statement.

The fully integrated BD Cor System allows 1,700 specimens to be loaded at a time, has onboard capacity for reagents and samples that provides eight hours of uninterrupted system processing, and can deliver approximately 2,000 results in 24 hours.

The panel detects and distinguishes bacterial vaginosis, Trichomonas vaginalis, and vulvovaginal candidiasis, commonly known as a yeast infection. The panel is also the only FDA-cleared test to provide separate results for Candida glabrata and C. krusei, as these two species are known to carry resistance to common antimicrobials, BD said.

Accurate diagnosis of these pathogens ensures appropriate treatment and decreases the risk of complications and resistance to treatment, BD said, and the use of a single test reduces repeat testing, unnecessary treatments, and the risk of contracting sexually transmitted infections due to lingering vaginitis symptoms.

"Most women have a vaginal infection during their lifetime, and millions of them receive inadequate treatment," said Nikos Pavlidis, VP of diagnostics for BD, citing a recent study that showed 40 percent of women did not receive the appropriate diagnosis and treatment for vaginitis after an initial physician visit.

"The BD Vaginal Panel can help end the cycle of repeat visits, misdiagnosis, and ineffective treatment for the millions of women suffering from vaginitis," Pavlidis said.

The BD Vaginal Panel is the third assay available for use on the BD Cor System in the US, in addition to the BD Onclarity HPV assay with extended genotyping and the BD CTGCTV2 molecular assay that detects Chlamydia trachomatis, Neisseria gonorrhoeae, and T. vaginalis.

With the clearance of the 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, BD said.