April 23, 2007 at 07:00 AM EDT
Cepheid and Instrumentation Laboratory Enter Into Strategic Agreement to Develop and Market Tests for Genetic Risk of Thrombosis
New GeneXpert(R) Test for Factor II and Factor V Mutations Enhances Thrombophilia Assessment in Hospitals

SUNNYVALE, Calif. and LEXINGTON, Mass., April 23 /PRNewswire-FirstCall/ -- Cepheid (NASDAQ:CPHD) a broad-based molecular diagnostics company, and Instrumentation Laboratory (IL), a leading clinical diagnostics company, today announced an exclusive development and distribution agreement for molecular diagnostic tests in Hemostasis. Cepheid will develop a line of tests for hemostasis applications to be used on its GeneXpert(R) System. IL will market these tests as a key complement to its panel of automated hemostasis diagnostic assays.

The first tests to be developed under the agreement will be the Xpert(TM) HemosIL Factor II and Factor V tests. These tests will detect Factor II G202210A (FII) and Factor V Leiden (FV) genetic variations associated with thrombophilia, an increased risk of blood clots (thrombosis). FII and FV are the most common hereditary risk factors for venous thrombosis. FII and FV mutations are present in as many as 7% and 60%, respectively, of thrombotic patients. They are, therefore, extremely important tools for the follow-up of patients with thrombosis and in assessing the need for prophylactic treatment in high risk conditions, as well as for familial investigations. The investigation of genetic and acquired defects leading to thrombosis is performed with the aid of both classic coagulation assays and molecular tests. In the past, many of these molecular tests could not be performed in a traditional hospital laboratory. Now, with the GeneXpert technology FV and FII molecular tests can be easily performed in the hospital or independent clinical laboratory.

"Because of the complexity of the technologies currently available, clinical laboratories often send samples to specialized molecular biology centers, with a turnaround time of up to one week. The introduction of GeneXpert and FII and FV molecular tests in the Hemostasis laboratory will have a significant impact in allowing the routine hospital or independent laboratory to perform these tests in-house, while reducing the cost and improving the turnaround time; thus, leading to a more efficient management of the patient," said Cepheid Chief Executive Officer John Bishop. "IL is a leader in the hemostasis market and an ideal partner for these valuable new molecular diagnostic tools."

"This agreement is another example of IL's commitment to innovation, automation and complete solutions for the Hemostasis laboratory. Today, we already offer the most complete and highest quality panel of assays for thrombophilia investigation. The addition of FII and FV molecular tests further increases the completeness and the value of our offering for thousands of Hemostasis laboratories worldwide," said Jose Manent, Chief Executive Officer of IL. "After review of the technologies and options available, we are convinced that there is no better technology available today than the GeneXpert system. We look forward to a successful partnership with Cepheid, who shares our commitment to innovation and dedication to improving patient care."

GeneXpert is the only system to combine 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 answers from unprocessed samples in minutes.

Representing a new approach to molecular diagnostics automation, the GeneXpert System is designed for a broad range of molecular diagnostic applications. The GeneXpert System is configurable with anywhere from 1 to 16 modules, allowing users to perform multiple molecular diagnostic tests simultaneously.

The GeneXpert Factor II/Factor V test will be exclusively marketed worldwide by IL. Currently in development, the test is targeted for potential regulatory review in late 2007.

About Instrumentation Laboratory

Instrumentation Laboratory (IL), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The company's product lines include critical care systems, hemostasis systems and information management systems. IL's GEM(R) product offerings, part of the critical care line, include the GEM Premier 3000 with Intelligent Quality Management (iQM(R)), GEM OPL(TM), a portable whole blood CO-Oximeter and the GEM PCL Plus, a portable Coagulation analyzer. IL's hemostasis portfolio includes the ACL TOP(R), a fully automated, high-productivity analyzer and the ACLELITE and ELITE PRO, the latest addition to the ACL family. IL also offers the HemosIL(R) line of reagents. IL is based in Lexington, Massachusetts. See www.ilus.com for more information.

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 http://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, timing of future product releases, clinical trials and regulatory processes. 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: risks relating to the development process for new products, including unforeseen delays and costs; the ability to complete clinical trials successfully in a timely manner; uncertainties related to the regulatory processes; risks relating to the reliance on an exclusive distribution relationship; the performance and market acceptance of any new product; sufficient customer demand in the other markets; our reliance on distributors to market, sell and support our products; the occurrence of unforeseen expenditures, acquisitions or other transactions; our success in increasing direct sales; 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 2006 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.

    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:
    Tricia Ross                         Chris Stamm / Alina Tuttle-Melgar
    Investor/Analyst Information        781-684-0770
    617-520-7064                        cepheid@schwartz-pr.comtross@financialrelationsboard.com

    At Instrumentation Laboratory
    Sally McCraven
    781-861-4577
    smccraven@ilww.com

Source: Cepheid

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