Cepheid Gains FDA Approval for C. Difficile Molecular Diagnostic
Test will be available before the end of the month.
FDA gave Cepheid the go-ahead to market Xpert®, a C. difficile test that can reportedly detect the bacterium in 45 minutes. It has been cleared for the direct detection of toxigenic C. difficile from stool specimens.
The test targets the Toxin B gene, discovered in 1978 to be the cause of antibiotic-associated diarrhea and colitis. The Toxin B (tcdB) gene is the critical component of all toxigenic C. difficile strains including the epidemic 027/NAP1/BI strain, according to the company.
“The Xpert C. difficile test establishes new levels of speed, accuracy, and ease-of-use for CDI (C. difficile infection) testing,” claims John Bishop, CEO.
“Toxigenic culture offers high sensitivity but laboratories find it burdensome and far too slow for practical diagnostic use,” Dale Gerding, M.D., professor of medicine, division of infectious diseases, Loyola University Chicago Stritch School of Medicine. “Instead, many use less labor-intensive toxin EIA (enzyme immunoassay) and GDH (glutamate dehydrogenase) tests, which fail to detect 20-50% of cases. A rapid, accurate CDI test will eliminate needless repetitive testing and enable us to implement appropriate treatment and infection control measures faster in our battle against this devastating healthcare associated infection (HAI).”
The Xpert C. difficile test is Cepheid's seventh to receive FDA clearance and fourth in its menu of HAI products. The test, which runs on Cepheid's GeneXpert® System, will be available for shipment the week of July 20.