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Cepheid Gains Expanded FDA Clearance With CLIA Waiver for Multiplex Vaginal Panel

NEW YORK – Danaher subsidiary Cepheid said on Thursday that it has received US Food and Drug Administration clearance with CLIA waiver for its Xpert Xpress Multiplex Vaginal Panel. 

The PCR-based panel, which detects bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis, can now be performed in near-patient settings. The assay returns results within an hour from a single sample and runs on Cepheid's GeneXpert Xpress instruments, the Sunnyvale, California-based company said in a statement.

"Misdiagnosis of the specific underlying causes of vaginitis and vaginosis often leads to inappropriate and ineffective treatments and, in some cases, an increased risk of developing serious complications and antibiotic resistant organisms," David Persing, Cepheid's executive VP and chief medical and scientific officer, said in a statement. "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."

The Xpert Xpress MVP test first received FDA clearance in February 2022.