Cepheid Receives FDA Clearance for Xpert Norovirus, the First On-Demand Molecular Test for Detection of Norovirus

SUNNYVALE, Calif., Dec. 1, 2014 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market Xpert^® Norovirus, a qualitative in vitro diagnostic test for expeditious identification and differentiation of Noroviruses genogroup I (GI) and genogroup II (GII). Both Xpert Norovirus and the recently cleared Xpert Flu/RSV XC have also been categorized as Moderate Complexity tests. All Xpert tests run on Cepheid's GeneXpert^® System, the world's leading molecular diagnostic platform with more than 7,500 systems installed worldwide.

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 According to the Centers for Disease Control and Prevention, Norovirus is the leading cause of disease outbreaks from contaminated food, causes an estimated 21 million illnesses, and contributes to between 56,000 and 71,000 hospitalizations in the U.S. each year. ²

"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," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "To actively manage the infection, clinicians have previously been forced to choose between accuracy and time-to-result when selecting a testing method — now no compromise is required as Xpert Norovirus delivers both."

"Xpert Norovirus enables on-demand molecular detection and differentiation of the GI and GII Norovirus genogroups, which together account for the vast majority of human infections," said Dr. David H. Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "Norovirus outbreaks require immediate implementation of targeted infection control procedures, and this new test gives clinicians accurate results in as little as one hour."

Xpert Norovirus will begin shipping in the United States this month. For more information on Cepheid's GeneXpert Systems or the complete menu of Xpert tests, visit www.cepheid.com.

About Cepheid
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, fast, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.

References

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/
2. Centers for Disease Control and Prevention. Norovirus Overview. Accessed Nov 4, 2014. http://www.cdc.gov/norovirus/about/overview.html

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, the breadth and speed of test menu expansion, the results of clinical trials, and medical practice dynamics.  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; our ability to successfully develop new products; the completion of clinical trials for new products successfully and in a timely manner; uncertainties related to the United States FDA and other regulatory processes; the Company's ability to successfully introduce and sell products in clinical markets; the Company's research and development budget; 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.

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.

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SOURCE Cepheid