Cepheid Wins FDA & CLIA Nods for Multiplex Vaginal Panel

Cepheid has received U.S. Food and Drug Administration (FDA) clearance with CLIA waver for its Xpert Xpress MVP (multiplex vaginal panel).
 
The panel can now be done in near-patient settings, with results in 60 minutes from a single specimen for bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis (TV). The rest runs on the company’s GeneXpert Xpress instruments and is approved for testing women fourteen years and up.
 
The test can aid in detection of co-occurrences from a single sample and aims to significantly narrow the test-to-treatment gap and better support patient outcomes. The expanded claim provides further access to women’s and sexual health by making PCR testing available at the point of care, according to the company.
 
“Misdiagnosis of the specific underlying causes of vaginitis and vaginosis often lead to inappropriate and ineffective treatments and, in some cases, an increased risk of developing serious complications and antibiotic resistant organisms,” said David Persing, M.D., Ph.D., EVP, and chief medical and scientific officer of Cepheid. “With the addition of the CLIA Waiver for MVP in our growing women’s health portfolio, physicians can quickly and accurately identify their patient’s infection and prescribe the correct treatment regimen, with the goal of avoiding multiple office visits associated with therapeutic failure.”
 
Cepheid is a molecular diagnostics company that’s an operating company of Danaher Corporation’s diagnostics platform.