WARFARIN Study initiated to assess utility of genetic testing to reduce warfarin-related adverse events

Iverson Genetic Diagnostics, Inc. announced that the WARFARIN Study (Warfarin Adverse Event Reduction for Adults Receiving Genetic Testing at Therapy Initiation) was initiated at Colorado Heart & Vascular, P.C. in Denver and other 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.

“We are delighted to be an integral part of this research, and hope the data we contribute from Colorado Heart & Vascular will help improve patients' lives in the years to come.”

Warfarin is prescribed to 2 million patients in the U.S. annually and approximately 20 million Americans use the drug in total. Warfarin is difficult to dose as patients respond to it differently according to their genetic makeup - too much warfarin can result in severe bleeding, and too little can cause clot formation and increased risk of stroke. In the past, warfarin dosing relied on trial-and-error, which exposed patients to serious medical risks. Warfarin is the second most frequent cause of drug-related emergency room visits.

Over the past few years, two genetic variants have been identified that predict an individual's response to warfarin. Using genetic testing to guide physicians in starting warfarin therapy has the potential to reduce deaths, increase overall patient safety and lower national healthcare system costs. Given the magnitude of these potential improvements in warfarin use, the Centers for Medicare & Medicaid Services (CMS) has authorized the WARFARIN Study to gather data on the potential impact of a pharmacogenetic test to reduce serious bleeding and clotting episodes in patients. Upon review of the Study, the first such personalized medicine trial authorized by CMS, the agency may establish reimbursement for the genetic warfarin test, which is marketed by Iverson Genetic Diagnostics.

Leroy Hood, M.D., Ph.D., co-founder of the Institute for Systems Biology and a member of Iverson Genetic Diagnostics' Board of Directors, commented, "The technological tools for molecular discovery that we continue to develop become truly valuable when they can actually improve human health. CMS is to be commended for its leadership in authorizing the WARFARIN Study. This study marks a step towards our goal of improving patient outcomes through personalized care."

Researchers have identified two specific genes, VKORC1 (for warfarin sensitivity) and CYP2C9 (for warfarin metabolism), which contribute up to 40% of individual patient variations in response to using warfarin. The WARFARIN Study will assess the extent to which serious adverse events - hemorrhage and clotting - can be avoided when warfarin dosing is guided by genetic testing for these two genes, as compared to warfarin dosing calculated without these pharmacogenetic data.

"Colorado Heart & Vascular is one of the key sites in the national WARFARIN Study, which altogether will enroll more than 7,000 patients across the country," said Dr. Sam Mehta, Principal Investigator. "We are delighted to be an integral part of this research, and hope the data we contribute from Colorado Heart & Vascular will help improve patients' lives in the years to come."

The 18-month study will determine patients' rates of warfarin-related adverse events at 30, 60 and 90 days from initial warfarin dosing. Study results will be used by CMS for reimbursement decision-making. The multicenter, randomized, blinded, parallel-group study is being led by Principal Investigator Elizabeth Ofili, M.D., Chief of Cardiology, Director of Clinical Research, and Associate Dean for Clinical Research at Morehouse School of Medicine. Trial registration and study sites can be found at www.warfarinstudy.org.

"This landmark study is about more than warfarin," said Dean Sproles, CEO and Chairman, Iverson Genetic Diagnostics Inc., which initiated the WARFARIN Study. "It is about individualizing treatment to improve patient safety and outcomes, thereby reducing healthcare costs. CMS' support of the WARFARIN Study demonstrates their commitment to exploring the impact of genetic testing on individualized dosing, which may pave the way for other studies in the personalized medicine arena."

SOURCE Iverson Genetic Diagnostics, Inc.