Iverson Genetic Diagnostics, an SC Launch company, announced the company has received approval from the Center for Medicare and Medicaid Services (CMS) to conduct a WARFARIN Clinical Study. The two-year study will assess the impact of using genetic information in calculating doses on the rate of adverse events when initiating warfarin drug therapy.
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. The randomized and blinded, multi-center study will involve more than 7000 participants at over 50 sites nationwide. The rate of adverse events will be compared to the rate for patients receiving initial doses calculated without genetic data.
Iverson Genetic Diagnostics’ CEO Dean Sproles commented, “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 an 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.
Today, more than two 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 specific genes, VKORC1 and CYP2C9 that contribute up to 60% of individual patient variations in response to using warfarin. The WARFARIN Study will evaluate changes in adverse events such as major bleeding or clotting when using genetic information to determine individualized warfarin dosages.
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.”
SCRA CEO Bill Mahoney added, “The ability for Iverson to locate a testing facility at the SCRA Innovation Center in Charleston will allow for a three hour turnaround time advantage over their west coast operations. We congratulate Iverson as they continue to improve and advance healthcare options, as well as augment South Carolina’s Knowledge Economy.”