Iverson Genetic Diagnostics announced the selection of UPS (NYSE:UPS) to provide shipping services for its upcoming WARFARIN Study. In late June of 2010, Iverson Genetic Diagnostics, Inc. received approval from the Centers for Medicare & Medicaid Services (CMS) to conduct a two-year study that will assess the impact of genetic information on the occurrence of adverse bleeding events when determining the initial dose of warfarin compared to adverse events for those not using genetics in dose determination. The randomized and blinded, multi-center study will involve more than 7,000 patients at over 50 hospital sites nationwide.
“Warfarin is an essential drug for preventing blood clots. However, the adverse event rates need to be lowered. This study should help us understand how to use each patient’s genetic information to deliver a safer and more effective dose.”
“CMS’s approval of WARFARIN is evidence of the growing role of genetics in helping physicians to develop optimal individual treatments for their patients. The data from this study will determine if the use of genetics in warfarin dosing reduces adverse health events. Physicians need to make dosing decisions about warfarin on the spot,” said Dean Sproles, CEO and founder, Iverson Genetics. “We look forward to partnering with UPS to bring the benefits of genetic testing to physicians and their patients in a timely manner.” The CMS approval is for a clinical study under Coverage with Evidence Development (CED) and will cover pharmacogenetic testing of CYP2C9 and VKORC1 alleles to predict warfarin responsiveness.
Warfarin (brand name Coumadin®) is a commonly used anticoagulant (blood thinner). The dose of warfarin must be individualized for each patient according to his or her response to the drug. Currently, these individual dose requirements are often evaluated on a trial-and-error basis.
Today, more than 2 million patients are prescribed warfarin in the United States each year. One to five percent experiences a major bleeding event. The annual cost associated with warfarin complications is estimated to be $1.1 billion. (1) Researchers have identified two genes, VKORC1 and CYP2C9 that contribute up to 60% of an individual’s variability in response to warfarin. The WARFARIN Study will evaluate changes in adverse events such as major hemorrhagic or thromboembolic events when using genetic information to determine an individual’s warfarin dose. The WARFARIN Study is being led by Principal Investigator Elizabeth Ofili, MD, Director of Clinical Research, Chief of Cardiology and Associate Dean for Clinical Research at the Morehouse School of Medicine in Atlanta, Georgia. Dr. Ofili indicated that, “Warfarin is an essential drug for preventing blood clots. However, the adverse event rates need to be lowered. This study should help us understand how to use each patient’s genetic information to deliver a safer and more effective dose.”
“UPS is delighted to be Iverson’s trusted shipping provider for such a monumental study. It’s another example of how we can help make a difference in patients’ lives through our healthcare logistics services,” said Bill Hook, vice president of Global Strategy, UPS Healthcare Logistics. “Serving the supply chain needs of healthcare companies around the world is a core focus for UPS, either through transportation, distribution or specialized healthcare services.”
For this endeavor, UPS will send test kits and shipping materials to Iverson’s clinical study sites that are recruiting patients for the warfarin trial. UPS will also transport vital research patient specimens back reliably and quickly to Morehouse School of Medicine for earliest possible analysis. Enrollment in WARFARIN will commence in November of 2010.
1 McWilliam A, Letter R, and Nardinelli C. (2006) Health care savings from personalized medicine using genetic testing: the case of warfarin. Working Paper 06-23, AEI-Brookings Joint Center for Regulatory Studies.
Source:
Iverson Genetic Diagnostics, Inc.
UPS
Morehouse School of Medicine
View drug information on Warfarin Sodium tablets.