CMS rejects petition to strengthen genetic testing

September 11, 2007

CMS rejects petition to improve standards for genetic testing.

CMS has rejected a petition that called for the agency to exercise its authority under the Clinical Laboratory Improvement Amendments (CLIA) to improve the standards for genetic testing laboratories. The petition was filed in 2006 by the Genetics & Public Policy Center, Public Citizen, and the Genetic Alliance in an effort to increase proficiency testing-a practice that would provide independent analysis that a laboratory produces reliable results when performing tests. CMS to date has not mandated proficiency testing for genetic test laboratories, claiming that not many are available and the barriers to developing more are technological and financial in nature. The Genetics & Public Policy Center argues that more than two dozen proficiency tests have already been developed for genetic tests by the College of American Pathologists; however, laboratories are not required to enroll in them. The CMS' full response is available on the Genetics & Public Policy Center Web site at www.dnapolicy.org/resources/CMSresponse8.15.07.pdf.

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