BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its Vaginal Panel diagnostic on the COR system.
The comprehensive diagnostic test directly detects the three most common infectious causes of vaginitis. It uses the BD COR, the company’s high-throughput molecular diagnostic platform for large laboratories.
Franklin Lakes, New Jersey-based BD originally received marketing authorization for the panel for its BD MAX system. It’s the first microbiome-based polymerase chain reaction (PCR) assay that uses a single swab and test to simultaneously detect organisms with the three common causes: bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).
The panel reports a clear positive or negative result for each condition separately. Clearance marks the first authorization for a high-throughput version of the test, BD said in a news release.
Read: How the BD diagnostics business is driving greater access to care
More about the BD Vaginal Panel
If a test comes through positive for VVC (commonly known as a “yeast infection”), the panel is the only FDA-cleared nucleic acid amplification test that provides separate results for C. glabrata and C. krusei — two Candida species known to carry resistance to traditional antimicrobials — to ensure proper treatments are prescribed.
BD said the panel is the third assay available for use on its COR system in the U.S. It follows the Onclarity HPV assay and the CTGCTV2 assay. CTGCTV2 detects from one sample the three most prevalent non-viral sexually transmitted infections. Vaginal Panel clearance means labs can now offer both that and CTGCTV2 testing from one swab and one patient collection.
BD’s COR system allows the loading of 1,700 specimens at one time. Its onboard capacity for reagents and samples provides more than eight hours of unimpeded system processing. The system can deliver nearly 2,000 sample results in 24 hours.
“Most women have a vaginal infection during their lifetime and millions of them receive inadequate treatment,” said Nikos Pavlidis, VP 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.”