At Home DNA Tests:
Marketing Scam or Medical Breakthrough?
Hearing before the U.S. Senate Special Committee on Aging
July 26, 2006
In July 2006, the U.S. Senate Special Committee on Aging examined government regulation of at-home genetic tests and the science behind them. The highlight of the hearing was an undercover investigation in which staff members of the U.S. Government Accountability Office (GAO) submitted DNA samples to four Web sites that offered testing. The investigators submitted 12 samples taken from a cheek swab of a 9-month-old female and two from an unrelated 48-year-old man but described the specimens as coming from adults of various ages and lifestyle descriptions. Three of the sites made different recommendations for nine of the infant's samples. Since the DNA of these samples was identical, this showed that these recommendations were not actually based on the sender's "unique genetic profile" as advertised. Two of the sites recommended "personalized" supplement regimens that, in addition to being senseless, cost more than 30 times as much as comparable products available at retail outlets. Experts who reviewed the test reports concluded that they made predictions that were medically unproven, ambiguous, and provided no meaningful information for consumers.
Statements of Committee Members
- Gregory D. Kutz, Managing Director, Forensic Audits and Special Investigations, Governmental Accountability Office, Washington, DC
- Kathy Hudson, Director, Genetics & Public Policy Center, Johns Hopkins University, Berman Bioethics Institute, Washington, DC
- Rosalynn Gill-Garrison, Chief Science Officer, Sciona, Boulder, Colorado
- Carol Reed, VP and Chief Medical Officer, Genaissance Pharmaceuticals, Newton, Massachusetts
- Kristopher King, CEO, Suracell, Montclair, New Jersey
- Rama Rathnam, President, Genox, Baltimore, Maryland
- Howard Coleman, CEO, Genelex Corporation, Seattle, Washington
- Thomas Hamilton, Director, Survey and Certification Group, Centers for Medicare and Medicaid Services, US Department of Health and Human Services, Washington, DC
- Steven M. Gutman, MD, Director, Office of in Vitro Diagnostic Devices, Food and Drug Administration, Washington, DC
This page was posted on February 28, 2008.