Cepheid Announces European Release of Xpert Norovirus, the First On-Demand Molecular Test for Detection of Norovirus Accurate Norovirus Detection in as Short as One Hour
SUNNYVALE, Calif., April 10, 2014 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced the release of Xpert® Norovirus, a qualitative in vitro diagnostic test for rapid identification and differentiation of Noroviruses genogroup I (GI) and genogroup II (GII), to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. The test runs on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform.
Norovirus is a highly contagious virus and is the most common cause of viral gastroenteritis worldwide. Noroviruses can be transmitted from an infected person, contaminated food or water, or by touching contaminated surfaces. Nausea, vomiting, watery diarrhea, and abdominal pain characterize infection. Globally, the virus affects approximately 267 million people and causes over 200,000 deaths each year.1
"Norovirus exposure is an unfortunate fact of life. The associated illness can spread quickly in the hospital setting and be very serious, especially in young children and older adults. To actively manage the infection, clinicians have been forced to choose between accuracy and time-to-result when selecting a testing method — but now Xpert Norovirus delivers both," said John Bishop, Cepheid's Chairman and Chief Executive Officer.
Noroviruses are divided into five genogroups, GI to GV. Xpert Norovirus detects and differentiates the GI and GII genogroups, which account for the majority of human infections.
"In the hospital setting, patients admitted with severe Norovirus infection can be a source of this infection to other patients," said Dr. Kate Templeton, Honorary Senior Lecturer in Medical Microbiology at the University of Edinburgh, and a Consultant Clinical Scientist in Microbiology. "It is important that patients infected with Norovirus are identified as early as possible. Rapid molecular testing, when combined with prompt infection control measures of infected patients, provides an important new weapon in our battle against healthcare associated infections."
"Xpert Norovirus is the first test of its type to provide STAT molecular detection of this emerging nosocomial pathogen," said Dr. David H. Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "Norovirus outbreaks require immediate implementation of infection control procedures and this new test gives clinicians accurate results in as little as one hour."
Xpert Norovirus is now available as a CE-IVD Mark product. For more information on Cepheid's GeneXpert Systems or a complete menu of CE-IVD Xpert tests, visit www.cepheidinternational.com.
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.
1. Patel MM, Widdowson MA, Glass RI, Akazawa K, Vinje J, et al. (2008) Systematic literature review of role of noroviruses in sporadic gastroenteritis. Emerg Infect Dis 14: 1224–1231. doi: 10.3201/eid1408.071114 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600393/
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 the performance, speed and accuracy of our products, including relative to competing products, and the use of our products in medical practice. 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: test performance in the field; utilization of our tests by clinicians; uncertainties related to the United States FDA, European and other regulatory processes; unforeseen supply, development and manufacturing problems; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; the impact of competitive products and pricing; the Company's ability to manage geographically-dispersed operations; and underlying regulatory, political and market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, and its other reports filed with the Securities and Exchange Commission.
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