American Heart Association Praises FDA Action on Laboratory Developed Tests
Washington, D.C., July 31, 2014 — American Heart Association President Elliott Antman, M.D., issued the following comments today on the Food and Drug Administration’s (FDA) draft framework on the regulation of laboratory developed tests (LDTs):
“The action taken today by the FDA will ultimately ensure that diagnostic and genetic tests will yield the safe, effective and reliable results that patients and their doctors can trust. The American Heart Association has long advocated for the release of FDA guidance on these tests and we look forward to participating in a public dialogue on the proposed framework.
Our growing understanding of genetics’ role in disease has helped to flood the market with many new tests designed to assess the risk for cardiovascular disease. Many medical professionals have expressed concern that the advertised claims of these tests may not be supported by scientific evidence. Yet even high-risk tests remain on the market with no regulation. Despite the lack of test quality, patients are using them to assess their risk for disease, potentially causing their doctors to take action based on an inaccurate or misleading results.
We recognize that advanced diagnostics hold tremendous promise for patients, but the increasingly pivotal role of these tests in health care makes it imperative that their safety and effectiveness is confirmed by the FDA prior to use. The goal of the risk-based FDA framework released today is to reassure patients on the reliability and usefulness of diagnostic tests and set clear parameters for the developers of new tests.
The American Heart Association looks forward to working with the FDA once the guidance is issued so that patients have the most accurate and reliable information when making critical treatment decisions.”
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