Iverson Genetic Diagnostics said this week that the Franciscan Health System in Tacoma, Wash., has begun enrolling patients for the WARFARIN (Warfarin Adverse Event Reduction for Adults Receiving Genetic Testing at Therapy Initiation) study that the company is leading in an effort to demonstrate the utility of genetic testing to guide dosing of the blood-thinner warfarin.
The Franciscan Health System marks the tenth site that has begun enrolling patients for the trial, which kicked off in March with funding from the Centers for Disease Control and Prevention (PGx Reporter 3/9/2011).
John Baek, an Iverson spokesperson, told PGx Reporter that the company expects another five sites to initiate over the next several weeks. He added that another 16 sites have committed to begin enrollment and have IRB approval and the company is currently working on scheduling initiation dates with these centers' principal investigators.
The company ultimately hopes to enroll around 7,000 patients at 50 sites nationwide.
Franciscan's participation will be conducted through the Franciscan Research Center.
The WARFARIN study is assessing whether warfarin dosing that is informed by the use of genetic testing — specifically, tests for variants in the VKORC1 and CYP2C9 genes — will reduce the incidence of hemorrhage and clotting as compared to warfarin dosing calculated without pharmacogenetic information.
The 18-month study will determine patients' rates of warfarin-related adverse events at 30, 60 and 90 days from initial warfarin dosing. Iverson said that CMS will use the study results for reimbursement decision-making.
Iverson noted that around 100,000 patients experience warfarin-related adverse events each year and estimated that DNA testing to improve the safety and effectiveness of the drug could result in total cost savings to the US healthcare system of around $1.1 billion.