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WARFARIN Study Launched to Assess Impact of Genetic Testing in Reducing Hospitalizations and Deaths Caused by Warfarin
Date:3/1/2011

ients.  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.  The 18-month study will enroll more than 7,000 patients at up to 50 study sites nationwide; patients' rates of warfarin-related adverse events will be studied 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 Diagnost
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SOURCE Iverson Genetic Diagnostics, Inc.
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