Healthcare Industry News:  chronic myelogenous leukemia 

Diagnostics Oncology

 News Release - February 23, 2006

Cepheid Initiates CE IVD Products in Europe With Launch of GeneXpert(R) System and Xpert BCR-ABL Monitor(TM) Assay

SUNNYVALE, Calif., Feb. 23 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ), a broad-based molecular diagnostics company, today announced the European launch of the GeneXpert® System for in vitro diagnostic use (IVD) along with the Xpert BCR-ABL Monitor(TM) assay, the initial clinical diagnostic test for use on the GeneXpert® System. Both the GeneXpert System and the Xpert BCR-ABL Monitor assay were released as "Conformite Europeene" or "European Conformity" CE IVD Mark products under the European Directive on In Vitro Diagnostic Medical Devices. The Xpert BCR-ABL Monitor can be used by hematologist-oncologists and labortorians as an aid in the monitoring of BCR-ABL, an abnormal genetic marker found in patients with chronic myelogenous leukemia (CML).

"The GeneXpert® System has been demonstrated to be robust, easy to use and capable of delivering sensitivity and specificity not previously seen in molecular testing," said John Bishop, Cepheid CEO. "In the European clinical molecular diagnostics market the ability of the clinician to obtain immediately actionable intelligence is critical to patient management. We believe the GeneXpert® System is in a unique position to deliver on this clinical need."

The GeneXpert System and the Xpert BCR-ABL Monitor assay is the world's first closed system, quantitative, nested real-time PCR (polymerase chain reaction) assay. This assay allows healthcare providers in Europe to obtain timely, near-patient, highly sensitive and accurate results from a blood sample, with minimal potential for RNA loss or sample contamination. The GeneXpert System combines sample preparation with real time nested PCR amplification and detection for fully-automated DNA and RNA analysis. The system purifies, concentrates, detects and identifies targeted nucleic acid sequences. The BCR-ABL assay provides in approximately 2 hours. Current techniques for performing the same complex sample prep, reverse transcription, and PCR procedures involve skilled technicians in centralized molecular labs performing batched manual tasks that can take two to three days to complete.

chronic myelogenous leukemia (CML) is part of a group of diseases called myeloproliferative disorders. There are approximately 20,000 CML patients living in remission in Europe today. Current Europe Against Cancer Program practice guidelines for management of patients with CML call for use of quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) assays during the initial workup of patients with chronic phase CML and in monitoring for minimal residual disease, and in identifying patients who may be at a high risk for relapse. Patients may have their blood tested as many as four times a year.

The GeneXpert® System is currently the only real-time PCR 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 field. The GeneXpert® System was released in the Biothreat surveillance market in 2004 and has subsequently been proven to be an extremely robust and accurate platform technology with over 1,100 modules and systems in the market generating over 2.1 million anthrax test results.

About Cepheid

Cepheid (Nasdaq: CPHD ), based in Sunnyvale, Calif., is a molecular diagnostics company that develops, manufactures, and markets fully-integrated systems for genetic analysis in the clinical, industrial and biothreat markets. The company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company's easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See 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. 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; 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 2005 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.

Source: Cepheid

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