Warfarin dosing roulette image

Cardiovascular Biomarkers

C-Path entered into a $2 million collaborative agreement with the FDA to evaluate genetic tests for their ability to predict safer and more effective doses of the anticoagulant, warfarin (Coumadin®). Warfarin is a generic drug widely prescribed as a blood thinner to prevent dangerous blood clots. The optimal dose varies widely from patient to patient. If the dose is too high, the patient may have serious bleeding and conversely, if the dose is too low, the patient may suffer a stroke or embolism. In both these situations, death or serious disability can follow. The intent of this grant is to reduce these adverse events from warfarin by scientific review of the evidence and to gain consensus on how genetic tests can be used to better guide the selection of initial doses.

The three-year collaborative agreement was announced in June 2006. Scientists at Intermountain Health in Salt Lake City serve as clinical and scientific consultants, and C-Path will evaluate the pharmacogenetic testing methods used in clinical trials. This effort will include evidence-based evaluation of data to help the FDA determine recommendations of genotype-guided dosing of warfarin.  This project also supports work to evaluate scientific data on biomarkers that predict the safety of drugs used in the treatment of cardiovascular disease, especially heart failure.

Research has identified numerous biomarkers that have the potential for predicting human response to new therapies. These biomarkers could also improve the ability of commercial sponsors to develop more effective treatments for cardiovascular disease. However, because of the overall low response rate without a predictive test, few of these reach the market and fewer become routine components of therapy. One of the factors that has limited development of biomarkers is the lack of a clear path to FDA approval for such assays. A goal of this C-Path program is to clarify such a path to approval that will aid pharmaceutical and diagnostic companies as they develop new drugs and diagnostics. The new process created by the FDA for this project is serving as a model pathway for other personalized medicines.