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Clinical Data, GWU to Study Benefits of Using PGx to Dose Warfarin

NEW YORK (GenomeWeb News) — Clinical Data’s PGxHealth division will work with clinical researchers at George Washington University to study the effectiveness of using genomic testing to guide dosing decisions for the widely used anticoagulant warfarin, the company said yesterday.
 
The studies will use Clinical Data’s PGxPredict:Warfarin in a trial involving 80 post-surgical GWU patients to “evaluate the potential clinical, safety, and treatment-time benefits of using the genetic test to determine optimal warfarin dosing.”
 
Doctors at GWU’s Medical Faculty Associates Department of Orthopedic Surgery will conduct the study by using CD’s test to determine warfarin dosing in half of the subjects, the company said.  
 
If the program shows positive results, the company said GWU could incorporate the test into the clinic’s standard practices.
 
According to Clinical Data, the Clinical Pharmacology Subcommittee of the Food and Drug Administration’s Advisory Committee for Pharmaceutical Sciences said that “sufficient mechanistic and clinical evidence exists to use lower doses of warfarin for patients with genetic variations in CYP2C9 that lead to reduced activity and genotyping patients in the induction phase of warfarin therapy [which] would reduce adverse events and improve achievement of stable INR in patients with genetic variations in CYP2C9.”
 
Also, “sufficient mechanistic and clinical evidence exists to use lower doses of warfarin for patients with genetic variations in VKORC1 that lead to reduced VKORC1 activity and genotyping patients in the induction phase of warfarin therapy [which] would reduce adverse events and improve achievement of stable INR in patients with genetic variations in VKORC1.”

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