"The contract will provide funding for the development of an integrated single module GeneXpert system and a test cartridge to detect influenza viruses A and B, and H5N1, thereby providing general clinical utility for seasonal flu diagnosis in addition to its application in an influenza pandemic. In the event of an avian influenza pandemic, rapid detection of the H5N1 virus and accurate differentiation of this agent from other common causes of respiratory illness will serve a critical role in diagnosis and subsequent treatment of avian influenza cases," said Cepheid Chief Medical and Technology Officer, David H. Persing, MD, Ph.D. "The only proven test methods based on PCR detection of the viral genome, are technically complex and are typically confined to highly specialized central laboratories. Currently available PCR systems do not provide the rapid turnaround or on-demand, 24/7 availability that is necessary for real-time decisions to be made regarding antiviral therapy or patient management. The GeneXpert system is the ideal platform for bringing state-of-the-art molecular diagnostic technology to the frontlines of medical practice," continued Dr. Persing.
According to the World Health Organization, since 2003 there have been 258 human cases of Avian Influenza, with an overall mortality rate of over 50%. Apart from vaccination, the most effective means of controlling the spread of an influenza pandemic is early case recognition, followed by isolation and antiviral therapy. Rapid antigen-based tests available today are insensitive and are not designed to specifically identify H5N1. Antiviral treatment is most effective at treating and preventing the spread of the virus when it is given before the peak onset of influenza viral syndrome. The new Xpert Influenza test under development will detect the common forms of human influenza virus (influenza A/B) as well as the H5N1 variant directly from nasal and throat swabs in approximately 30 minutes.
"The technology embedded in the GeneXpert platform constitutes precisely what developing nations like Indonesia need in combating threats like avian influenza. The ease, simplicity and relatively low cost of the diagnosis of H5N1 virus using this assay system will allow an expanded reach and reliability of surveillance to levels unimaginable with currently deployed diagnostic technologies," said J. Kevin Baird, Ph.D., Director, ALERTAsia Foundation, Jakarta, Indonesia, a collaborator in the contract that will provide samples for testing. "ALERTAsia looks forward to working with our committed friends at Cepheid, the Eijkman Institute for Molecular Biology, the National Institute of Health Research and Development of the Republic of Indonesia, the U.S. Department of Health and Human Services, and the U.S. Centers for Disease Control and Prevention in making this bright vision a reality across the length of the Indonesian archipelago."
About the GeneXpert Molecular Diagnostic Platform
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of false positive results due to contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences and deliver diagnostic answers from unprocessed samples in approximately 30 minutes, whereas manual testing methods comprising the same advanced technology require several hours to several days. Cepheid's Xpert GBS test recently received FDA clearance for use in CLIA "Moderate Complexity" laboratories, the first such designation for a PCR-based test. The modular design of the GeneXpert Platform allows it to be adapted to a variety of laboratory environments, ranging from high-volume testing in reference and hospital laboratories to use in physician offices and urgent care centers.
About Cepheid
Cepheid (Nasdaq: CPHD - News), based in Sunnyvale, Calif., is a molecular diagnostics company that develops, manufactures, and markets fully-integrated systems for use in clinical, industrial and biothreat markets. The company's systems enable rapid, on-demand genetic testing by automating otherwise complex manual laboratory procedures. The company's easy-to-use test cartridges perform a number of complicated and labor-intensive steps, including sample preparation, nucleic acid extraction and purification, DNA or RNA target amplification, and fluorescence-based detection. By vertical integration of advanced nucleic acid chemistry, proprietary genetic targets, molecular biology and engineering, the company has focused on high-value applications in which rapid, on-demand molecular testing is particularly important. Clinical applications include identification of viruses and drug-resistant bacteria, certain genetic polymorphisms, and some types of cancer. Industrial applications of Cepheid technology include food, agricultural, and environmental testing. In addition, the Company has developed some of the most widely used systems for detection of agents of biothreat agents. See www.cepheid.com for more information.
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 and usage in the clinical diagnostics market and future products for the clinical market. 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: the fact that the contract is a phase/milestone-based agreement, with no assurance that the entire amount of the contract will be funded beyond Phase 2; availability of future funds to fund the remainder of the agreement; unforeseen development and delivery problems; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the availability and impact of competitive products or products that the government deems more advantageous; pricing; and underlying market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2005 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.
CONTACTS: At the Company: John L. Bishop John R. Sluis CEO, Cepheid CFO, Cepheid 408-541-4191 408-541-4191 john.bishop@cepheid.com john.sluis@cepheid.com At Financial Relations Board: At Schwartz Communications: Lasse Glassen Chris Stamm or Thomas Keane Investor/Analyst Information 415-512-0770 310-854-8313 cepheid@schwartz-pr.com lglassen@financialrelationsboard.com
Source: Cepheid
