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Cepheid receives FDA clearance for Xpert HemosIL FII & FV test 30-minute test for genetic risk of thrombosis improves time-to-result over previous molecular tests.

Cepheid (Sunnyvale, CA) and Instrumentation Laboratory (IL) (Bedford, MA) announced that Cepheid has received clearance from the United States Food & Drug Administration (FDA) to market its Xpert HemosIL FII FII Federated Investors Inc. (Pittsburgh, PA)
FII Foreign Institutional Investor
FII Falling Into Infinity (Dream Theater album)
FII Fundación Instituto de Ingeniería
 & FV test. The test detects Factor II (FII) and Factor V Leiden factor V Leiden Hematology A variant of factor V present in 3%-8% of Caucasians associated with a ↑ risk of DVT. See LETS, Hereditary thrombophilia.  (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 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 United States," 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 hemostasis /he·mo·sta·sis/ (he?mo-sta´sis) (he-mos´tah-sis)
1. the arrest of bleeding by the physiological properties of vasoconstriction and coagulation or by surgical means.

2.
 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 San Francisco General Hospital is the main public hospital in San Francisco, California, and the only Level I Trauma Center serving San Francisco and San Mateo. The hospital budget is for only 302 beds at SFGH.  & Trauma Center and the University of California, San Francisco Coordinates:  . "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 United States will now have the ability to perform, in combination with our ACL See access control list.

1. ACL - Access Control List.
2. ACL - Association for Computational Linguistics.
3. ACL - A Coroutine Language.

A Pascal-based implementation of coroutines.

["Coroutines", C.D.
 TOP 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 (Interactive VideoDisc) See interactive video.  mark product since March 2008. With FDA clearance, IL will now exclusively distribute the product worldwide.

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 product offerings, part of the critical care line, include the GEM Premier 4000 analyzer with Intelligent Quality Management (iQM), the new GEM Premier 3500 analyzer with iQM and the GEM PCL (Printer Command Language) The page description language for HP LaserJet printers. It has become a de facto standard used in many printers and typesetters. PCL Level 5, introduced with the LaserJet III in 1990, also supports Compugraphic's Intellifont scalable fonts.  Plus, a portable coagulation analyzer. 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 (1) (Clear To Send) The RS-232 signal sent from the receiving station to the transmitting station that indicates it is ready to accept data. Contrast with RTS.

(2) (Common Type System) The data typing used in .
. 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.

Cepheid 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.

Cepheid

+1-408-400-8377

www.cepheid.com

Instrumentation Laboratory

+1-781-861-4577,

www.ilww.com
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Publication:BIOTECH Patent News
Date:Aug 1, 2009
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