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Overhaul of Genetic and Other Advanced Diagnostic Testing Regulations Necessary for Personalized Medicine, HHS Secretary Told
Date:5/5/2009

A joint announcement of the Genetics & Public Policy Center and the Coalition for 21st Century Medicine

WASHINGTON, May 5 /PRNewswire-USNewswire/ -- To "get personalized medicine right," Health and Human Services (HHS) Secretary Sebelius will need to "create and implement a reasonable and responsible regulatory framework" for genetic tests and other advanced medical diagnostics, a diverse coalition of more than a hundred organizations representing genetic testing laboratories, patient advocates, investors, and health policy researchers said today.

In a letter to the newly confirmed Secretary, the group noted that while accurate, reliable, and timely genetic testing offers enormous promise to help shape our healthcare system to meet the challenges of the 21st century, "poor quality testing can harm patients and waste scarce resources." Physicians already are using genetic tests - currently available clinically for some 1,500 diseases or conditions - to diagnose disease, to predict an individual patient's risk of future disease, and to guide decision making about further diagnostic procedures and choices among therapeutic options. "Advanced diagnostic testing is becoming the standard of care for many diseases," the group told Sebelius.

Regulatory oversight of genetic testing needs to "strike the right balance between assuring patient safety and embracing policies that encourage the incorporation of rapidly advancing scientific methods and knowledge," the group wrote. Moreover, "it is essential that new regulatory oversight policies be clearly stated and publicly vetted before they are implemented," they said.

The new regulatory framework should "put patients first, be grounded in science, appropriately incentivize innovation, and be fully consistent with established statutes," the group counseled. Its letter outlines three goals Secretary Sebelius should adopt in crafting a framework of
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SOURCE The Coalition for 21st Century Medicine
Copyright©2009 PR Newswire.
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