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Cepheid Extends Rapid Molecular Diagnostics' Leadership with FDA Clearance of Xpert Clostridium difficile/Epi
Date:4/11/2011

SUNNYVALE, Calif., April 11, 2011 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Xpert® C. difficile/Epi test. Cepheid's first Xpert C. difficile test has been available in the United States since July 2009. The test's unique combination of high sensitivity and rapid turnaround time has quickly established Xpert C. difficile as the molecular market leader. Building on the success of Xpert C. difficile, which detects the bacterium that causes C. difficile infection (CDI), Xpert C. difficile/Epi additionally and simultaneously identifies the epidemic strain of C. difficile, also known as 027, NAP1 or BI.

"Compared to less virulent strains, C. difficile 027 strains produce higher levels of spores which pose greater infection control challenges," said John Bishop, Cepheid's Chief Executive Officer.  "Additionally, there is a growing body of evidence that the 027 strain is associated with more frequent relapses and ultimately higher mortality rates. The 027 differentiation is therefore a welcome addition to Cepheid's Xpert test portfolio."

Among C. difficile cases, the prevalence of the epidemic 027 strain is increasing(1). Although the Xpert C. difficile/Epi test is not intended to guide specific patient treatment decisions, it will identify those patients infected with the epidemic strain and therefore at greater risk.

"We believe that detection of the 027 strain provides important epidemiologic information, particularly for institutions facing an outbreak of CDI, and Cepheid is very pleased to be the first to offer a test that specifically identifies the 027 strain with the accuracy, speed, and ease-of-use that our customers have come to expect from the Xpert family of tests," said Da
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