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 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 GeneXpert® system, is Cepheid's tenth Xpert test to receive FDA clearance. It is expected to be available for shipment the week of May 16.
Based in Sunnyvale, Calif., 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.
This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to product performance, future products and future market opportunities. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: unforeseen manufacturing problems; uncertainties in the regulatory review process for new products; regulatory developments and practices regarding testing; customer and market acceptance of the product; the failure of the product to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the product; and underlying market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K and in its most recent quarterly report on Form 10-Q, each filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.
(1) - Louie T, Miller M, Mullane K, et al. Fidaxomicin versus Vancomycin for Clostridium difficile Infection. N Engl J Med 2011 ; 364 :422-31