In response to recent publicized concerns over direct-to-consumer (DTC) genetic testing, a hearing was held on July 22, 2010, by the Oversight and Investigations Subcommittee of the Committee on Energy and Commerce. Testimony was provided by:

• Gregory Kutz, Managing Director, Forensic Audits and Special Investigations, Government Accountability Office
• Jeff Shuren, MD, JD, Director, Center for Devices and Radiological Health, Food and Drug Administration
• James Evans, MD, PhD, Editor-in-Chief, Genetics in Medicine; Bryson Professor of Genetics and Medicine, University of North Carolina at Chapel Hill
• Ashley Gould, General Counsel, 23andMe, Inc.
• Vance Vanier, MD, President and Chief Executive Officer, Navigenics, Inc.
• David Becker, PhD, Chief Scientific Officer, Pathway Genomics Corporation

The highlight of this meeting was the presentation of a report on an investigation conducted by the Government Accountability Office (GAO) on DTC testing companies. The results of this two-tier investigation, which involved risk predictions for 15 disorders using duplicate specimens for 5 individuals sent to 4 DTC companies, showed a high level of discrepant results and a lack of risk figures provided for individuals described as “African American” or “Asian.”

The GAO also anonymously contacted 15 DTC testing companies to ask about their services and claims made on websites. In 67% of cases, fraudulent claims were made, ranging from false claims of celebrity endorsement to overblown claims of the power of the tests, among others. Two companies also indicated that a woman could test her fiancé’s DNA sample without his knowledge as a “surprise” despite that surreptitious testing is illegal in 33 states.

Downloadable transcripts of the experts’ testimonies and a short video of the GAO investigation are available here.