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The Current Landscape for Direct-to-Consumer Genetic Testing: Ethical, Legal, and Policy Issues

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Publication Date: September 2008

Publisher(s): Annual Reviews, Inc.

Author(s): David Melzer; Gail Javitt; Stuart Hogarth

Funder(s): National Human Genome Research Institute (U.S.); Pew Charitable Trusts

Funder(s): National Human Genome Research Institute (U.S.); Pew Charitable Trusts

Topic: Health (Medical research and technology)
Law and ethics (Health law)

Keywords: DNA profiling; Personalized genomics; Government regulation

Type: Other

Coverage: United States

Abstract:

This review surveys the developing market for direct-to-consumer (DTC) genetic tests and examines the range of companies and tests available, the regulatory landscape, the concerns raised about DTC testing, and the calls for enhanced oversight.

We provide a comparative overview of the situation, particularly in the United States and Europe, by exploring the regulatory frameworks for medical devices and clinical laboratories. We also discuss a variety of other mechanisms such as general controls on advertising and consumer law mechanisms.

In Annual Review of Genomics and Human Genetics, 2008, vol.9, p.161-182.