Osmetech starts clinical trials of new markers for warfarin test
This article was originally published in Clinica
Executive Summary
UK AIM-listed company Osmetech has started clinical trials for an extended version of its eSensor warfarin sensitivity test, which will incorporate additional biomarkers, including CYP450 4F2. The company, which also has US operations in Pasadena, California and Boston, exclusively licensed the marker from the Marshfield Clinic, Wisconsin, in November 2007. It expects to file for US FDA 510(k) clearance before the end of this year. Meanwhile, the company has launched its gene test for CYP450 2C9 (CYP2C9) drug metabolism. The gene is involved in the metabolism of 10% of all drugs, including warfarin and statins. It will be available for research use only on the eSensor XT-8 system. A recent evaluation of the eSensor XT-8 instrument, presented at the Association for Molecular Pathology meeting in Texas, found it has 100% accuracy and reproducibility.