Genetic testing - some background

In a recent report, the Congressional Research Service (CRS) noted that several bills relating to genetic and genomic technology and testing were introduced in the 109th Congress. Although none passed, "they signal the growing importance of the public policy issues surrounding the clinical and public health implications of new genetic technology." In its report, CRS summarizes fundamental concepts in genetics and provides an overview of genetic tests and key policy issues.

The Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) regulate genetic tests through the Clinical Laboratory Improvement Amendments (CLIA) of 1988 (P.L. 100-578). CRS emphasizes that CLIA regulates the analytical validity of genetic tests but not their clinical validity and thus is subject to criticism that it "does not go far enough to assure the accuracy of genetic tests."

Genetic Testing: Scientific Background for Policymakers, CRS Report RL33832 (pdf, 13pp/108kB, from Open CRS), January 26, 2007