Sam Brusco, Associate Editor03.16.23
BD (Becton, Dickinson and Company) has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD vaginal panel on its BD COR system. The comprehensive diagnostic test detects the three most common infectious causes of vaginitis.
The BD vaginal panel, according to the company, is the first microbiome-based polymerase chain reaction (PCR) assay that uses a single swab and test to simultaneously detect organisms associated with bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV), and reports a clear positive or negative result for each condition separately.
"Most women have a vaginal infection during their lifetime and millions of them receive inadequate treatment," Nikos Pavlidis, VP of Diagnostics for BD told the press. "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."
If a test if positive for VVC (yeast infection), the vaginal panel is the only FDA-cleared Nucleic Acid Amplification Test (NAAT) that provides separate results for C. glabrata and C. krusei—two Candida species known to carry resistance to traditional antimicrobials.
The BD vaginal panel is the third assay available on the BD COR system in the U.S.
The BD vaginal panel, according to the company, is the first microbiome-based polymerase chain reaction (PCR) assay that uses a single swab and test to simultaneously detect organisms associated with bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV), and reports a clear positive or negative result for each condition separately.
"Most women have a vaginal infection during their lifetime and millions of them receive inadequate treatment," Nikos Pavlidis, VP of Diagnostics for BD told the press. "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."
If a test if positive for VVC (yeast infection), the vaginal panel is the only FDA-cleared Nucleic Acid Amplification Test (NAAT) that provides separate results for C. glabrata and C. krusei—two Candida species known to carry resistance to traditional antimicrobials.
The BD vaginal panel is the third assay available on the BD COR system in the U.S.