C-Path receives $750,000 FDA grant

The U.S. Food and Drug Administration has awarded C-Path in Tucson a $750,000 grant to evaluate genetic tests and determine whether such tests can accurately predict how individuals will respond to certain drugs.

The study will specifically look at individual responses to heart failure drugs. It will also involve the University of Utah, which has an electronic database of 16,000 heart failure patients and a long history of researching the role of inheritance and genetics in medicine.

C-Path is a nonprofit institution whose mission is to "create innovative programs in education and research that enable the safe acceleration of the process for developing new medicines." One of C-Path's main goals is to create programs that address drug safety issues.

"Heart failure is one of the leading causes of deaths in the United States," Woosley said. "We believe with this partnership we will be able to determine which genetic tests will help predict drug response."

As an example of what the study will evaluate, Woosley pointed to the class of drugs called angiotensin converting enzyme (ACE) inhibitors.

"There is genetic research that's been done that would suggest if you have a certain gene in your body, you would be more likely to respond to ACE inhibitors," he said. "That's great science, but it's not a validated test to the level that the FDA requires."

C-Path aims to validate these tests so they can be approved by the FDA for future, commercial use.

"This process should produce enough information so that the FDA can authorize the genetic tests and write a guidance on how a drug can be developed for heart failure drugs using genetic tests," Woosley said.

The $750,000 grant from the FDA is new money appropriated by the federal government specifically to fund the FDA's Critical Path Initiative. The initiative, from which C-Path takes its name, aims to improve the efficiency and safety of medical product development.

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