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Cepheid Receives Enhanced FDA Clearance Alongside CLIA Waiver for Multiplex Vaginal Panel

NextEdge Admin

10 Jan 2024

2 min 1 sec

Cepheid, a subsidiary of Danaher, announced on Thursday that its Xpert Xpress Multiplex Vaginal Panel has received clearance from the US Food and Drug Administration (FDA) along with a Clinical Laboratory Improvement Amendments (CLIA) waiver. This PCR-based panel is designed to detect bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis and can now be conducted in near-patient settings. Operating on Cepheid’s GeneXpert Xpress instruments, the assay provides results within an hour from a single sample.

According to a statement from the Sunnyvale, California-based company, the ability to perform the Xpert Xpress MVP test in near-patient settings is crucial in addressing the misdiagnosis of underlying causes of vaginitis and vaginosis. The test’s quick and accurate results aim to enable physicians to identify infections promptly, prescribe the correct treatment regimen, and potentially reduce the need for multiple office visits associated with therapeutic failure.

David Persing, Cepheid’s Executive Vice President and Chief Medical and Scientific Officer, emphasized the significance of avoiding inappropriate and ineffective treatments, as well as the risk of developing serious complications and antibiotic-resistant organisms associated with misdiagnoses. The Xpert Xpress MVP test initially received FDA clearance in February 2022, and this recent CLIA waiver further enhances its utility in Cepheid’s expanding women’s health portfolio.