Publication Date: September 2008
Publisher: Annual Reviews, Inc.
Author(s): David Melzer; Gail Javitt; Stuart Hogarth
Research Area: Health; Law and ethics
Keywords: DNA profiling; Personalized genomics; Government regulation
Coverage: United States
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.