SUNNYVALE, Calif., Oct. 26 /PRNewswire-FirstCall/ -- Cepheid today announced the launch of the GeneXpert(R) System into the molecular clinical research field. The initial product for use on the GeneXpert(R) System in this field is a Research Use Only (RUO) product for the identification of cells carrying the BCR/ABL chromosomal translocation. This initial use is not for use in diagnostic procedures. The BCR/ABL product is part of a broader program directed at investigating its potential use for monitoring patients with Chronic Myelogenous Leukemia (CML). Both the GeneXpert(R) System and the BCR/ABL product will be available for shipment on an RUO basis starting on November 15, 2005.
The GeneXpert(R) System is currently the only molecular platform that integrates microfluidic sample preparation with the sensitivity of real-time polymerase chain reaction (PCR)-based molecular detection resulting in the first easy-to-use system in this rapidly growing field. The GeneXpert(R) System was released in the Biothreat market in 2004 and has subsequently been proven to be an extremely robust and accurate platform technology with over 984 modules and systems in the market generating over 1.4 million anthrax test results. The system is expected to deliver new levels of sensitivity, accuracy, and standardization.
“The GeneXpert(R) System has been demonstrated to be robust, highly sensitive and capable of delivering specificity not previously seen in molecular testing. As we move in to the Clinical Molecular Diagnostics market, we expect the GeneXpert(R) System to deliver immediately actionable intelligence critical to patient management,” said John Bishop, Cepheid CEO. “Near term, we expect the GeneXpert(R) System will be utilized in both laboratories and in more decentralized test settings. This is expected to reduce delays in being able to obtain test results for infectious diseases and oncology testing areas.”
About Cepheid
Cepheid , based in Sunnyvale, Calif., is a leading developer, manufacturer and marketer of fully integrated systems that enable genetic assessment when and where it is needed. Founded in 1996, the company is commercializing its technology and products worldwide for research, medical, and industrial applications requiring assessment of the human genome, infectious disease and 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 timing of expansion in the clinical diagnostics 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: development and manufacturing problems; our ability to successfully obtain regulatory approvals and introduce new products in the clinical market; the performance and market acceptance of new products; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and 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 2004 and “Factors that Might Affect Future Results” 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.comjohn.sluis@cepheid.com At Financial Relations Board: Tricia Ross Investor/Analyst Information 617-520-7064 tross@financialrelationsboard.com
Cepheid
CONTACT: John L. Bishop, CEO, john.bishop@cepheid.com, or John R. Sluis,CFO, john.sluis@cepheid.com, both of Cepheid, +1-408-541-4191; orInvestor/Analyst Information, Tricia Ross of Financial Relations Board,+1-617-520-7064, tross@financialrelationsboard.com, for Cepheid
Web site: http://www.cepheid.com//
