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Cepheid Receives FDA Clearance for First On-Demand Molecular Diagnostic Test for Clostridium difficile Infection
Date:7/13/2009

n Control and Epidemiology (APIC) found that on any given day there are more than 7,000 patients in the United States suffering from CDI, causing the deaths of approximately 300 patients per day. The disease, which can range in severity from mild to severe diarrhea, pseudomembranous colitis, toxic megacolon, sepsis, and death, is costing American healthcare institutions up to $51.5 million per day.

"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."

As CDI rates continue to rise throughout the world, a more virulent epidemic strain, known as 027/NAP1/BI, has now been detected in at least 48 states, Canada, and throughout Europe. The Xpert C. difficile test has been cleared for the direct detection of toxigenic Clostridium 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 Clostridium difficile strains -- including the epidemic 027/NAP1/BI strain. Cepheid will also continue to work closely with the FDA to deliver an additional product featuring simultaneous differentiation of the 027/NAP1/BI epidemic strain.

The Xpert C. difficile test is Ceph
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