On March 16 Senators Barack Obama and Richard Burr introduced the Genomics and Personalized Medicine Act of 2007. S. 976, a modified version of the Genomics and Personalized Medicine Act introduced last year, aims to advance the study of human genes to better predict patients’ susceptibility to certain diseases or conditions, and better customize drugs and medical treatments to meet patients’ unique needs.

Among other provisions, the bill would direct the secretary of Health and Human Services to improve the safety and effectiveness of genetic tests. The secretary would be required to commission a study from the Institute of Medicine that would make recommendations regarding the development of a “decision matrix” for use in determining which tests to regulate and how they should be regulated. The secretary would be required to implement the decision matrix within 18 months of the bill’s passage and to assign responsibility for reviewing tests to the Food and Drug Administration (FDA) or the Centers for Medicare and Medicaid Services (CMS), or neither, depending on how the test is evaluated under the matrix. Pending implementation of the matrix, FDA would be prohibited from requiring premarket review of any laboratory-developed test. The bill also would require CMS to develop specialty areas for at least some genetic tests, and to develop criteria for establishing both the analytical and clinical validity of tests determined to be within the agency’s purview.

The Genomics and Personalized Medicine Act of 2007 shares with the Laboratory Test Improvement Act introduced by Senators Kennedy and Smith the goal of improving oversight of genetic tests, though the two bills take distinctly different approaches.

Both bills can be accessed through Thomas

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