03/26/2007 - Almost exactly a year ago today the Genetics and Public Policy Center told this committee of our strong concern about genetic testing oversight. Specifically, we highlighted the absence of a specialty area for genetic tests under CLIA to ensure the analytical validity of genetic tests, and the absence of oversight by FDA to ensure the clinical validity of the vast majority of genetic tests.
Sadly, little has changed over the last year and we still have a grossly inadequate system of oversight to ensure genetic test quality.
One thing that has changed is that this committee is focusing on the issue of oversight. We are pleased that you are paying attention. I would like to use these few minutes to review what has occurred with respect to CMS oversight specifically and to respond to some of the inaccurate statements that have been made to you and in other forums by CMS officials. I would also like to address the need to ensure clinical validity of tests and to enhance transparency of test information for health care providers and consumers.
Read the entire statement of Kathy Hudson before the Secretary’s Advisory Committee on Genetics Health and Society.
Pew is no longer active in this line of work, but for more information, visit the Genetics & Public Policy Center Web site or visit the Genetics and Public Policy Centeron PewHealth.org.