Healthcare Industry News: Real-Time PCR
News Release - February 25, 2008
Cepheid and Instrumentation Laboratory Introduce Xpert(TM) HemosIL(R) FII & FV Assay to European Clinical Testing MarketNew GeneXpert(R)-Based Test to Assess Genetic Risk of Thrombosis Improves Time to Result and Eliminates Delays Associated with Batch Processing
SUNNYVALE, Calif., and LEXINGTON, Mass., Feb. 25 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ) and Instrumentation Laboratory (IL), a leading clinical diagnostics company, today announced the release of the Xpert (TM) HemosIL® FII & FV assay as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Delivering results in just over thirty minutes with a single GeneXpert® cartridge, the Xpert HemosIL FII & FV assay detects Factor II (FII) and Factor V Leiden (FV) genetic variations associated with thrombophilia, an increased risk of blood clots (thrombosis). Developed and manufactured by Cepheid, the test is expected to be available for sale beginning March 4th through IL, the exclusive worldwide distributor for the Xpert HemosIL FII & FV assay.
Xpert HemosIL FII & FV is the first test to be commercialized under the exclusive development and distribution agreement for hemostasis molecular diagnostic tests, entered into by IL and Cepheid in April 2007.
"Given the complexity of traditional molecular diagnostics, clinical laboratories currently may wait up to a week for FII and FV genotyping. The Xpert HemosIL FII & FV assay will allow laboratories to perform the test as needed -- and integrate the results with other tests -- providing physicians a comprehensive thrombophilia profile of their patients," said Cepheid Chief Executive Officer John Bishop. "Given the strength of its HemosIL line of hemostasis assays, IL is the ideal partner for the distribution of this and potentially other important tests for the hemostasis laboratory. This test represents a differentiated continuation of our menu expansion program."
FII and FV are the most common hereditary risk factors for venous thrombosis and are key in the determination of genetic predisposition to the condition and the need for prophylactic treatment in high risk patients. 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, Cepheid's GeneXpert System enables FII and FV molecular tests to be easily performed in the hospital or independent clinical laboratory without the need for batch processing.
"The introduction of the Xpert HemosIL FII & FV test will complement IL's line of fully automated assays for the hemostasis laboratory, including Antithrombin, Protein C, Protein S, Homocysteine and Lupus Anticoagulants. In combination with our ACL TOP® Family of systems, the availability of the Xpert HemosIL test on the GeneXpert System will enable our customers to perform a complete thrombophilia work-up, rapidly, efficiently and accurately," said Josep Manent, Chief Executive Officer of IL. "This is another example of IL's dedication to innovation, automation and complete solutions for the hemostasis laboratory. We look forward to continuing our relationship with Cepheid and to expanding our product offering for hemostasis laboratories around the world."
About the GeneXpert Molecular Diagnostic Platform
The GeneXpert System eliminates the need for batch processing. In the past, laboratories have waited to collect samples, so they could run tests in batches to best utilize laboratory resources; this often resulted in delayed patient care. 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 contamination. It 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, thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of test and volume demands of any clinical environment.
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® product offerings, part of the critical care line, include the GEM Premier 4000 and GEM Premier 3000 analyzers with Intelligent Quality Management (iQM®), 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®, a fully automated, high-productivity family of analyzers and the ACL ELITE(TM) and ELITE PRO analyzers. IL also offers the HemosIL® line, the most complete line of automated reagents for the routine and specialty hemostasis laboratory. IL is based in Lexington, Massachusetts. See http://www.ilus.com for more information.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD ) is an on-demand 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 and future market opportunities. 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: unforeseen manufacturing problems; regulatory developments; customer and market acceptance of the product; the failure of product to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the products; 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 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.
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