American College of Medical Genetics responds to new FDA labeling decision fo...(s as accurate as most genetic tests and ...)

Date:8/23/2007

s as accurate as most genetic tests and that there is strong evidence to support the relationship between the genetic variant(s) and the final dose of warfarin in patients. Further, The report states that there are situations in which one should perform genetic tests when prescribing warfarin. In particular, it states in the conclusion that CYP2C9 and VKORC1 genotypes can reasonably be used as part of diagnostic efforts to determine the cause of an unusually low maintenance dose of warfarin or an unusually high INR (the test used to monitor warfarin) during standard dosing, said Michael S. Watson, PhD, FACMG, Executive Director of the American College of Medical Genetics who commissioned the study in 2006 with funding provided by the American College of Medical Genetics Foundation. However, the ACCE review and the work group noted that there are still significant gaps in our knowledge of the clinical utility and the balance between harm, benefit and cost. Resolving this is necessary before genetic testing becomes the standard of care for all patients undergoing anticoagulation with warfarin. There are also insufficient data about the impact of this testing on adverse events.

In response to the need for more information on implementing genetic testing into warfarin dosing, the American College of Medical Genetics will release a position statement in fall 2007 in the journal Genetics in Medicine which will provide the details of how the experts interpreted the evidence as to the use of these genetic tests to inform warfarin dosing.

With 30 million Americans on warfarin and 2 million or more adverse side effects reported annually, the potential for genetic testing to minimize pain and suffering is tremendous. Genetics will continue to play an ever-increasing role in the prevention, diagnosis and treatment of disease, said Joe Leigh Simpson, MD, FACMG, President of the American College of Medical Genetics.

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Contact: Kathy Beal kbeal@acmg.net 301-238-4582 American College of Medical Genetics Source:Eurekalert

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