Genetic Testing
This article was originally published in SRA
Executive Summary
US FDA approves test for warfarin sensitivity
US FDA approves test for warfarin sensitivity
The US Food and Drug Administration (FDA) has approved a genetic test to determine whether patients may be especially sensitive to the widely used anticoagulant warfarin1. The Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test, manufactured by Nanosphere for use on the Verigene test system, can detect some variants of two genes linked with unexpected responses to warfarin. Patients with these gene variants have a higher risk of life-threatening bleeding.
The FDA approved updated labelling for warfarin-containing drugs in August, adding information about the variant genes to the direct dosing information2. The new test is intended for use alongside clinical evaluation and other tools to determine the best treatment and dosing options.
References
1. FDA press release, 17 September 2007, www.fda.gov/bbs/topics/NEWS/2007/NEW01701.html
2. The Regulatory Affairs Journal - Pharma, 18(9), 653