elcuidadodelasalude.org



WARFARIN study to explore impact of genetic testing on individualized dosing

April 02, 2016

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.  

"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.