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On August 9, 2006, U.S. Senator Barack Obama (D-Ill.) introduced the Genomics and Personalized Medicine Act to advance personalized medicine by increasing funding for genomics research, eliminating regulatory obstacles, and creating incentives for the development of companion diagnostic tests. Specifically, the proposed legislation would allocate $150 million for genomics research and provide a 100 percent tax credit for private research to develop diagnostic tests that can improve the effectiveness or safety of certain drugs.
To improve the quality of genetic testing, the bill also instructs CMS to develop a genetic testing specialty under the CLIA regulatory program and calls on the FDA to expand their oversight of genetic tests. Affymetrix supports these initiatives and earlier this spring, Dr. Janet Warrington, Vice President for Emerging Markets and Molecular Diagnostics Research and Development, sent a letter to Dr. Mark McClellan, the CMS Administrator, requesting the creation of a genetic testing specialty under CLIA.
In 2004, Affymetrix launched the world?s first diagnostic microarray system, through a partnership with Roche Diagnostics. This test was the first microarray based diagnostic to receive FDA approval and since then, has provided clinicians with a validated and regulated pharmacogenetic test to guide their prescribing decisions. Affymetrix has also forged additional partnerships focused on the development of microarray-based diagnostic products. Accelerating the development and use of these diagnostic products will help improve the lives of millions of Americans suffering from chronic diseases and conditions.
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