Warfarin Sensitivity Test Detects Three Genetic Markers

Through detection of these genetic markers, doctors are better able to accurately and efficiently determine the appropriate warfarin dosage level. Individuals respond to warfarin differently, and if its administration is not managed carefully, life-threatening side effects may occur.

Warfarin is the most widely prescribed oral anticoagulant in North America and Europe with an estimated two million new patients in the United States each year. Warfarin is the second-most-likely drug, after Digoxin, to cause adverse events requiring hospitalization. A recent economic study concluded that widespread use of warfarin sensitivity testing in the United States could avoid 85,000 serious-bleeding events and 17,000 strokes a year, saving healthcare costs of approximately US$1 billion annually and improving patient care.

Osmetech plc (Boston, MA, USA) announced that it received 510(k) clearance from the U.S. Food & Drug Administration (FDA; Rockville, MD, USA) for its eSensor A warfarin sensitivity test. The company also received FDA clearance for its second-generation eSensor XT-8 molecular diagnostics platform.

The eSensor XT-8 supports a broad menu of tests and provides accurate results while minimizing technician involvement. The features of the eSensor XT-8 system compare favorably to those of other molecular detection systems. Its ease of use, readily interpretable results, speed, and low maintenance are particularly suited to the needs of the decentralizing market.

James White, CE, Osmetech said, "With key technological and regulatory challenges having now been met, we are confident of further commercial success with the launch of our new eSensor XT-8 platform supported by a growing menu of tests planned to include pharmacogenetics, genetic diseases and infectious diseases.”

Osmetech is an international diagnostics company serving the high growth molecular diagnostic market. It serves hospitals and reference laboratories. Osmetech has a strong portfolio of over 200 issued and pending patents and has launched its first-generation eSensor 4800 platform, an electrochemistry-based array system, together with an FDA- cleared in vitro diagnostic test for cystic fibrosis carrier detection.


Related Links:
Osmetech
U.S. Food & Drug Administration