News | April 25, 2007

Development Agreement Announced for Molecular Diagnostic Tests in Hemostasis

April 26, 2007 - Cepheid, a broad-based molecular diagnostics company, and Instrumentation Laboratory, a clinical diagnostics company, announced a development and distribution agreement for molecular diagnostic tests in hemostasis. Cepheid will develop a line of tests for hemostasis applications to be used on its GeneXpert System. IL will market these tests as a key complement to its panel of automated hemostasis diagnostic assays.

The first tests to be developed under the agreement will be the Xpert HemosIL Factor II and Factor V tests. These tests will detect Factor II G202210A (FII) and Factor V Leiden (FV) genetic variations associated with thrombophilia, an increased risk of blood clots (thrombosis). FII and FV are the most common hereditary risk factors for venous thrombosis. FII and FV mutations are present in as many as 7 percent and 60 percent, respectively, of thrombotic patients. They are, therefore, important tools for the follow-up of patients with thrombosis and in assessing the need for prophylactic treatment in high risk conditions, as well as for familial investigations.

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, with the GeneXpert technology FV and FII molecular tests can be easily performed in the hospital or independent clinical laboratory.

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