SUNNYVALE, Calif. and BEDFORD, Mass., June 3 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD - News) and Instrumentation Laboratory today announced that Health Canada has issued Cepheid a medical device license for its Xpert HemosIL FII & FV test. The test detects Factor II (FII) and Factor V Leiden (FV) genetic variations associated with thrombophilia, an increased risk of blood clots (thrombosis). Xpert HemosIL FII & FV delivers results in just over thirty minutes using a single GeneXpert® cartridge. Developed and manufactured by Cepheid, the test will be available in Canada through a partnership with Instrumentation Laboratory (IL), the exclusive worldwide distributor for the Xpert HemosIL FII & FV test.
"Given the complexity of traditional molecular diagnostics, clinical laboratories currently may wait up to a week for FII and FV genotyping," said John Bishop, Chief Executive Officer at Cepheid. "The Xpert HemosIL FII & FV test will allow Canadian laboratories to perform the test on-demand -- and integrate the results with other tests -- providing physicians a more comprehensive thrombophilia profile of their patients."
FII and FV are the most common hereditary risk factors for venous thrombosis and key in the determination of genetic predisposition to the condition and the need for prophylactic treatment in high-risk patients. Testing for genetic and acquired defects, which may lead 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 on-demand FII and FV molecular tests to be easily performed in the hospital or independent clinical laboratory.
"This license for Xpert HemosIL FII & FV allows us to begin coordinating the commercialization of the product in Canada, with our partner, Beckman Coulter, Inc. This unique test will be a valuable addition to our robust HemosIL product line of fully automated assays in Canadian hemostasis laboratories," said Josep Manent, Chief Executive Officer of IL. "In combination with our ACL TOP® Family of Testing Systems, the Xpert HemosIL test on the GeneXpert System will enable our Canadian customers to perform a complete thrombophilia work-up, rapidly, efficiently and accurately."
Xpert HemosIL FII & FV is the sixth GeneXpert-based test to receive a Health Canada Medical Device License.
About Instrumentation Laboratory
Instrumentation Laboratory (www.ilus.com), 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 hemostasis portfolio includes the ACL TOP® Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP and the new ACL TOP 500 CTS. IL also offers the new ACL AcuStar Hemostasis Testing System, the ACL ELITE® and ELITE PRO, other hemostasis analyzers and the HemosIL® line of reagents. IL's GEM® product offerings, part of the critical care line, include the GEM Premier(TM) 4000 analyzer with Intelligent Quality Management (iQM®), the new GEM Premier 3500 analyzer with iQM and the GEM PCL Plus, a portable coagulation analyzer. IL is based in Bedford, Massachusetts.
About Cepheid
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD - News) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests 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. 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 and practices regarding testing; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2008 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.
The Instrumentation Laboratory logo, HemosIL, ACL, ACL TOP, ACL ELITE, ACL AcuStar, iQM GEM, Premier and GEM OPL are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies, and may be registered in the United States Patent and Trademark Office and in other jurisdictions.
Media Inquiries at Cepheid:
Jared Tipton Cepheid Corporate Communications 408-400-8377 jared.tipton@cepheid.com
Investor Inquiries at Cepheid:
Jacquie Ross Cepheid Investor Relations 408-400-8329 investor.relations@cepheid.com At Instrumentation Laboratory:
Sally McCraven 781-861-4577 smccraven@ilww.com
