Clinical Data Announces Launch of Genetic Test for Warfarin Response
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Clinical Data, Inc. has announced that its PgxHealth™ division will provide a genetic test to clinicians that is associated with response to warfarin.
The ability to provide this test is a direct result of Clinical Data's recent execution of intellectual property licenses under which the Company has been granted commercialization rights relating to certain polymorphisms in the Vitamin K epoxide reductase complex gene (VKORC1; also known as VKOR).
Polymorphisms within the VKORC1 gene are one of the important predictors of response to warfarin.
Clinical Data notes that assessment of warfarin metabolism based on certain polymorphisms in the well-known CYP2C9 gene accounts for about 17% of the variability in warfarin dosing while analysis of the VKORC1 gene polymorphisms accounts for an additional 15% of the variability.
When combined with certain clinical parameters, 50% of the variability in response to warfarin can now be explained. It is anticipated that PGxHealth will make this test commercially available by year-end 2006.
Drew Fromkin, President and CEO, explained, "Warfarin is commonly prescribed for the treatment and prevention of blood clotting, but dosing is a challenging process requiring frequent monitoring to achieve a stable maintenance dose."
"A seemingly innocuous dose has the potential to be too much for some patients putting them at risk for serious hemorrhage while being sub-therapeutic in other patients leaving them at risk for thromboembolism that could lead to stroke or heart attack."
"We believe there is a compelling case to be made for the introduction of a genetic test for warfarin response given the time and resources devoted to monitoring patients being treated with warfarin and the significant value associated with optimizing patient outcomes through the appropriate use of this drug."
"Taking these licenses is a necessary step to commercializing this test as well as protecting our franchise and partnerships long term."
Carol Reed, M.D., Senior Vice President and Chief Medical Officer, said, "Recently discovered polymorphisms in the VKORC1 gene, the target of warfarin, interfere with the metabolism of warfarin."
"By licensing the underlying IP for VKORC1, PGxHealth is now able to put this new information together as a comprehensive warfarin genetic test."
"The improved test should, when combined with certain clinical information, explain or predict more than 50 percent of the variability in response to warfarin."
Despite its popularity and well-established efficacy, warfarin dosing for an intended therapeutic outcome remains challenging as this drug poses significant risks and can have serious side effects including life-threatening bleeding.
In addition, the optimal maintenance dose of warfarin for each patient is difficult to predict at the beginning of treatment, and it can take a month or more of frequent monitoring of the prothrombin time (PT, a test for blood coagulability) before a stable maintenance dose of warfarin is identified.
Changes in the PT may not always reflect only a change in warfarin dose because diet, concomitant medication and environmental factors can each influence PT test results.
In contrast, genetic information on the pharmacokinetic and pharmacodynamic properties of response to warfarin is not affected by such external factors.
It is anticipated that the PGxHealth warfarin test will provide clinicians with an understanding of how an individual patient will respond to warfarin.
