At the February 12-13 public meeting of the Secretary’s Advisory Committee on Genetics, Health, and Society, the committee spent the better part of two days finalizing recommendations to Health and Human Services Secretary Michael Leavitt regarding genetic testing oversight. The Secretary requested these recommendations last spring as part of his Personalized Medicine Initiative. The committee discussed comments submitted in response to its draft report on genetic testing oversight, and heard testimony from several of these stakeholders, including Center Director Kathy Hudson. The Center also submitted to the committee an analysis of stakeholder comments to the draft report.

Following a lively and sometimes contentious discussion, committee members voted to adopt a final set of 14 recommendations, which were transmitted to the Secretary in late February. The transcript of the public meeting reflects the recommendations adopted by the committee.

In its recommendations, the committee notes that it has identified significant gaps in the U.S. system for genetic testing oversight that could lead to harm, and that enhancements to current oversight could better protect the public. The committee recommends, among other enhancements, that laboratories performing genetic and all other “nonwaived” moderate- and high-risk tests be required to enroll in all available proficiency testing programs for the tests they perform.

Current regulations, which were implemented when genetic testing was in its infancy, do not require that genetic testing laboratories enroll in available proficiency testing (PT) programs. The Center has long argued for increased PT requirements, and therefore strongly supports the SACGHS recommendation regarding PT. The Center has drafted model regulatory language to easily and efficiently implement SACGHS’s recommendation, and has shared this model language with Secretary Leavitt.

SACGHS also recommends creating a mandatory, publicly-accessible, Web-based registry for genetic tests to enhance transparency regarding the analytic and clinical validity and clinical utility of genetic tests as well as the number of laboratories offering genetic testing services and the range of tests they offer. In her testimony, Hudson stressed the importance of a mandatory registry, and noted the significant stakeholder support for such a registry.

Additionally, the committee recommends that the Food and Drug Administration use its expertise to address laboratory developed tests and that a multi-stakeholder group establish criteria to tailor the level of review for such tests to the risk posed by the test.

The committee also suggests that a number of federal agencies, including the Federal Trade Commission and CMS, increase their monitoring of direct-to-consumer genetic testing companies and take action against those that make false or misleading claims.

The full set of recommendations will be incorporated into the committee’s final report, which will be released in May 2008. – Gail Javitt

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