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Osmetech's thrombophilia risk test approved in US

This article was originally published in Clinica

Executive Summary

The US FDA has granted 510(k) clearance for Osmetech's eSensor thrombophilia risk test. Thrombophilia causes an increased risk of blood clots in affected individuals, and can result from inherited defects in clotting factors. The multiplex test measures four genetic variants linked with thrombosis, in the genes for: factor V Leiden, factor II prothrombin, MTHFR 677 and MTHFR 1298. Osmetech (Pasadena, California) believes it is the only company to have received FDA clearance for all four markers. Roche Diagnostics already markets Factor V Leiden and Factor II (Prothrombin) G20210A test kits. Osmetech's test runs on its eSensor XT-8 system – the firm already has tests for warfarin and cystic fibrosis approved on this platform.

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