BD’s diagnostic test for infectious vaginitis gets 510(k) clearance

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Becton, Dickinson and Company (BD) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for the BD Vaginal Panel, which detects common types of infectious vaginitis, on the BD COR System.

The comprehensive diagnostic test uses BD’s high-throughput molecular diagnostic platform to directly detect the three most common infectious causes of vaginitis.

BD Diagnostics vice-president Nikos Pavlidis said: “A recent study showed that four out of ten women didn’t receive the appropriate diagnosis and treatment for their vaginitis symptoms after an initial physician visit, which led to four out of ten 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.”

The BD Vaginal Panel is said to be the first microbiome-based polymerase chain reaction (PCR) assay that can use a single swab to simultaneously detect organisms associated with bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).

Following testing, the panel provides a report with a clear positive or negative result for each condition.

The BD Vaginal Panel marks the third assay to be made available for use on the BD COR System in the US.

The first was the BD Onclarity HPV assay, an FDA-approved human papillomavirus (HPV) test to identify and report HPV genotypes, including HPV 16, 18 and 31. The second was the BD CTGCTV2 molecular assay, which tests for the three most prevalent non-viral sexually transmitted infections (STIs) – Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV) – from a single sample.

Claimed to be the only high-throughput, fully integrated preanalytical and analytical system on the market, the BD COR System provides access to critical women’s health and STI testing by enhancing patient management and laboratory operations.

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