September 26, 2006
Washington, D.C.


The Genetics and Public Policy Center, Genetic Alliance, and Public Citizen held a joint news conference to call on the Centers for Medicare and Medicaid Services (CMS) to provide better oversight of genetic testing. CMS’s failure to do so poses a risk to the public’s health, the groups said in a joint communication released Sept. 26.

The Human Genome Project unleashed a torrent of information about the human genome and the role of genetic variation in human health. As a result, genetic testing is now among the fastest growing areas of laboratory medicine, with tests for about 1,000 diseases clinically available today. Many of these tests can have a profound impact on individual health, informing such decisions as whether to undergo surgery, undertake chemotherapy, discontinue a medication, or to become pregnant or continue a pregnancy.

Congress enacted the Clinical Laboratories Amendments of 1988, known as CLIA, to ensure laboratory quality, and CMS is the agency responsible for its implementation. Unfortunately, while specific quality standards exist for laboratories conducting many other diagnostic procedures, CMS has never acted to ensure the accuracy and reliability of genetic tests. CMS recently announced that it would quickly put in place such regulations by creating a genetic testing "specialty," but has since reneged on that promise.

Speakers were Gail Javitt, J.D., MPH, director of law and policy at the Genetics and Public Policy Center; Sharon Terry, president and CEO, Genetic Alliance; and Peter Lurie, M.D., MPH, deputy director, Public Citizen’s Health Research Group.

Video Link:
http://www.dnapolicy.org/video/gentest2006/index.htm

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