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Cepheid and Instrumentation Laboratory introduce new venous thrombosis assay to European markets

Cepheid : 26 February, 2008  (New Product)
Cepheid and Instrumentation Laboratory (IL), a leading clinical diagnostics company, have released of the Xpert HemosIL FII and 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 and 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 4, 2008, through IL, the exclusive worldwide distributor for the Xpert HemosIL FII and FV assay.

Xpert HemosIL FII and FV is the first test to be commercialised under the exclusive development and distribution agreement for haemostasis 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 and 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 haemostasis assays, IL is the ideal partner for the distribution of this and potentially other important tests for the haemostasis laboratory. This test represents a differentiated continuation of our menu expansion programme.'

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 and FV test will complement IL's line of fully automated assays for the haemostasis 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 haemostasis laboratory. We look forward to continuing our relationship with Cepheid and to expanding our product offering for haemostasis laboratories around the world.'
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