Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

Original from: Cepheid

Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60 minutes from a single specimen for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care. The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.

Each year, about 10 million healthcare visits by women in the U.S. are related to vaginitis symptoms1. Diagnosis of vaginitis is often made through a clinical examination2 where the physician will prescribe a treatment regimen that may not be targeted to the patients' specific infection type. Sequential treatment failures prolong patient suffering and increase the potential for antimicrobial resistance. Since the causative agents are from three distinct pathogen classes, but present with similar symptoms3, a precise diagnosis afforded by multiplexed PCR testing can enable more targeted and timely treatments.

BV is the most common cause of the vaginitis/vaginosis syndrome, but vaginitis can also be caused by Trichomonas and yeasts such as Candida. Long-term antibiotic use is a major factor responsible for Candida overgrowth5, so identifying the underlying infection is critical to decrease the overuse of antibiotics. The rate of BV recurrence after therapy is high, often greater than 60 percent4, and compared to a molecular test, empiric approaches can miss 45.3% of positive cases and incorrectly identify 12.3% of negative cases as positives5.

"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. "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."

Xpert Xpress MVP aids clinicians in the detection of these infections, including co-occurrences from a single sample with a detection time within 60 minutes, significantly narrowing the test-to-treatment gap and better supporting patient outcomes.

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Source: Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP