Press Release: WARFARIN Study Launched to Assess Impact of Genetic Testing in Reducing Hospitalizations and Deaths Caused by Warfarin
First major personalized medicine study authorized by Centers for Medicare & Medicaid Services may drive reimbursement based on improved patient safety, reduced healthcare costs.
Bothell, WA, March 1, 2011
- Bothell, WA, March 1, 2011 -- Iverson Genetic Diagnostics, Inc. announced today that the WARFARIN Study (Warfarin Adverse Event Reduction for Adults Receiving Genetic Testing at Therapy Initiation) was initiated in major hospital systems nationwide to assess the utility of genetic testing to determine a personalized warfarin dose for individual patients to reduce their risk of serious bleeding or clotting events. Warfarin, the most commonly prescribed blood thinner worldwide, causes up to 100,000 serious and unnecessary adverse events every year, including thousands of deaths. Studies have shown that DNA testing can dramatically improve the safety and effectiveness of warfarin, with estimated savings to the U.S. healthcare system of approximately $1.1 billion...
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Updated 09.26.10: Sample Collection Instructions
Click here to watch the instructional video which gives step-by-step instructions on how to properly collect samples and order the tests for the study.
WARFARIN Study Purpose
The purpose of the WARFARIN Study is to determine the utility of genetic testing in reducing the incidence of adverse events, both bleeding and thromboembolism, associated with the initiation of warfarin therapy.
Press Release: CMS Approves Study of Genetic Testing to Improve Medicine Dosing
First-of-its-kind study to evaluate gene identification ability to predict patient response and
improve safety when dosing world's leading anti-blood clotting drug.
Atlanta, GA, July 16, 2010 - Iverson Genetic Diagnostics today announced the company has received approval from CMS to conduct a WARFARIN Clinical Study. The two-year (2) study will assess the impact of genetic information in calculating doses and the changes in the rate of adverse events when initiating Warfarin drug therapy. These changes will be compared against doses initiated without genetic data. The randomized and blinded, multi-center study will involve more than 7000 participants at over 50 sites nationwide.
The specific CMS approval is for a clinical study under Coverage with Evidence Development (CED) and will cover pharmacogenetic testing of CYP2C9 or VKORC1 alleles to predict warfarin responsiveness. Iverson Genetic Diagnostic's CEO Dean Sproles commented, "The CMS approval of the WARFARIN Study is evidence of the growing role of genetics in helping doctors to develop optimal individual treatments for their patients. The data from this study will contribute to determining if the use of genetics in warfarin dosing reduces adverse health events."
Warfarin is a commonly used anticoagulant (blood thinner) and is most commonly known by the brand name of Coumadin®. The dosage and administration of warfarin must be individualized for each patient according to his or her response to the drug. Currently, these individual responses are evaluated on a trial-and-error basis...
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