Market Tests For Genetic Risk Of Thrombosis Being Developed

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Molecular Diagnostic Tests

Cepheid announced an exclusive 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% and 60%, respectively, of thrombotic patients. They are, therefore, extremely 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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"Because of the complexity of the technologies currently available, clinical laboratories often send samples to specialized molecular biology centers, with a turnaround time of up to one week. The introduction of GeneXpert and FII and FV molecular tests in the Hemostasis laboratory will have a significant impact in allowing the routine hospital or independent laboratory to perform these tests in-house, while reducing the cost and improving the turnaround time; thus, leading to a more efficient management of the patient," said Cepheid Chief Executive Officer John Bishop. "IL is a leader in the hemostasis market and an ideal partner for these valuable new molecular diagnostic tools."

"This agreement is another example of IL's commitment to innovation, automation and complete solutions for the Hemostasis laboratory. Today, we already offer the most complete and highest quality panel of assays for thrombophilia investigation. The addition of FII and FV molecular tests further increases the completeness and the value of our offering for thousands of Hemostasis laboratories worldwide," said Jose Manent, Chief Executive Officer of IL. "After review of the technologies and options available, we are convinced that there is no better technology available today than the GeneXpert system. We look forward to a successful partnership with Cepheid, who shares our commitment to innovation and dedication to improving patient care."

GeneXpert is the only system to combine sample preparation with real time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences and deliver answers from unprocessed samples in minutes.

Representing a new approach to molecular diagnostics automation, the GeneXpert System is designed for a broad range of molecular diagnostic applications. The GeneXpert System is configurable with anywhere from 1 to 16 modules, allowing users to perform multiple molecular diagnostic tests simultaneously.

The GeneXpert Factor II/Factor V test will be exclusively marketed worldwide by IL. Currently in development, the test is targeted for potential regulatory review in late 2007.

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