Cepheid Receives FDA Clearance For Xpert(R) HemosIL(R) FII & FV Test

Main Category: Vascular
Also Included In: Medical Devices / Diagnostics;  Blood / Hematology;  Regulatory Affairs / Drug Approvals
Article Date: 25 Sep 2009 - 2:00 PDT

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Cepheid (Nasdaq: CPHD) and Instrumentation Laboratory (IL) announced that Cepheid has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(R) HemosIL(R) 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(R) cartridge. Developed and manufactured by Cepheid, the test will be available worldwide through a partnership with IL, the exclusive worldwide distributor for the Xpert HemosIL FII & FV test.

"The Xpert HemosIL FII & FV test is the first product developed in conjunction with our partnering model to be marketed in the U.S.," said John Bishop, Cepheid's Chief Executive Officer. "Programs such as this have been strategically developed to help provide incremental leverage in the development of a broad test menu for our GeneXpert System. IL is a leader in the hemostasis market and the Xpert HemosIL FII & FV test will enable laboratories to perform the test immediately -- and integrate the results with those from other tests -- providing physicians a more comprehensive thrombophilia profile of their 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. Cepheid's GeneXpert System enables rapid FII and FV molecular tests to be easily performed in the hospital or independent clinical laboratory.

"The availability of an FDA cleared test for FII & FV polymorphisms that is rapid, accurate, easy to use and performed on-demand is important for several reasons," said Alan H.B. Wu, PhD, Chief of the Clinical Chemistry, Toxicology and Pharmacogenomics Laboratories at San Francisco General Hospital & Trauma Center and the University of California, San Francisco. "First, labs will likely save money because such testing is performed in national reference or academic molecular diagnostic labs, often at significant cost and with the inherent delays of send-out testing. Second, with a turnaround time of about 30 minutes for the genetic test, results can be made available in real-time, to facilitate discussions between physician and patient."

"The response to the Xpert HemosIL FII & FV test from our customers in Europe has been extremely positive. We are very pleased that laboratorians in the U.S. will now have the ability to perform, in combination with our ACL TOP(R) Family of systems, a complete thrombophilia work-up, rapidly, efficiently and accurately," said Josep Manent, Chief Executive Officer at IL. "This is another example of IL's dedication to providing innovation in hemostasis to our customers around the world."

Xpert HemosIL FII & FV is Cepheid's eighth test to receive FDA clearance. IL has been exclusively distributing the test in Europe as a CE IVD mark product since March 2008. With FDA clearance, IL will now exclusively distribute the product worldwide.

About Instrumentation Laboratory

Instrumentation Laboratory, 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(TM) 4000 analyzer with Intelligent Quality Management (iQM(R)), the new GEM Premier 3500 analyzer with iQM and the GEM PCL Plus, a portable coagulation analyzer. IL's hemostasis portfolio includes the ACL TOP(R) 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(R) and ELITE PRO, other hemostasis analyzers and the HemosIL(R) line of reagents. IL is based in Bedford, Massachusetts.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) 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.

Source: Cepheid