Osmetech starts clinical trials of warfarin assay:
This article was originally published in Clinica
Executive Summary
Molecular diagnostics firm Osmetech has initiated clinical trials of its eSensor 2C9/VKOR test, assessing its use in identifying patients at risk for increased sensitivity to warfarin. Patients' genetic make-up may influence how they respond to the blood thinner. The trials are intended to support the company's 510(k) application for US marketing clearance for the 2C9/VKOR assay together with its eSensor XT-8 instrument. Pasadena, California-based Osmetech said that it expects to gain US approval and launch the genetic test in the first half of 2008. eSensor, and electrochemistry-based array system, is already launched in the US for cystic fibrosis carrier detection.