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US FDA Grants Approval To Cepheid’s Xpert C. difficile Test

Cepheid announced that the US Food & Drug Administration has granted approval to market its Xpert C. difficile test. It is an on-demand molecular diagnostic test designed for 45-minute detection of the bacterium which causes Clostridium difficile infection (CDI). The test is the first test for CDI to deliver both a high degree of accuracy and rapid turnaround.

The previous lack of an accurate and rapid diagnostic test for CDI has greatly impeded our ability to halt the increasing rate of CDI, which has taken a severe turn in the past several years. Patients can have their first diarrhea symptoms on a Monday and be dead by Thursday, said Dale Gerding, MD, professor of medicine, division of infectious diseases, Loyola University Chicago Stritch School of Medicine. Toxigenic culture offers high sensitivity, but laboratories find it burdensome and far too slow for practical diagnostic use. Instead, many use less labor-intensive toxin EIA (enzyme immunoassay) and GDH (glutamate dehydrogenase) tests, which fail to detect 20-50% of cases. From a practical standpoint, this means many patients are not subjected to proper isolation procedures that can curtail transmission of C. difficile. 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.

As the leader in molecular HAI testing, it is incumbent for Cepheid to provide healthcare institutions access to the most comprehensive suite of rapid and accurate HAI tests on the market. The Xpert C. difficile test establishes new levels of speed, accuracy, and ease-of-use for CDI testing, said John Bishop, Cepheid’s Chief Executive Officer. As Cepheid continues the development of innovative new diagnostic solutions, we will strive to measure our product design against a solid understanding of healthcare’s current, and future, needs for rapid and accurate diagnostic tests. Our novel approach for the Xpert C. difficile test, as measured against the true gold standard of toxigenic culture, delivered on that vision.

The test has been cleared for the direct detection of toxigenic Clostridium difficile from stool specimens. The test targets the Toxin B gene, which was discovered in 1978 to be the cause of colitis and antibiotic-associated diarrhea. The Toxin B (tcdB) gene is the important component of all toxigenic Clostridium difficile strains including the epidemic 027/NAP1/BI strain.

The Xpert C. difficile test is company’s seventh test to be granted FDA clearance, and fourth in its expanding menu of on-demand HAI products. The test will run on Cepheid’s GeneXpert System and will be available for shipment the week of July 20th.