Cepheid Extends Rapid Molecular Diagnostics’ Leadership with FDA Clearance of Xpert Clostridium difficile/Epi
New test identifies Epidemic 027 strain.
Sunnyvale, California, April 11, 2011—Cepheid announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Xpert(R) 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 David Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer. “The use of Cepheid’s special nucleic acid chemistry capability was critical to achieving the required performance levels of this sophisticated next-generation test, which targets two toxin genes and a regulatory point mutation.”
The Xpert C. difficile/Epi test, which runs on the GeneXpertR system, is Cepheid’s tenth Xpert test to receive FDA clearance. It is expected to be available for shipment the week of May 16.
About Cepheid
Based in Sunnyvale, California, Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
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