The Government Accountability Office unveiled testimony showing identical DNA samples yielding contradictory results from four companies it investigated: 23andMe, Decode Genetics, Pathway Genomics, and Navigenics. The report comes as a new wave of letters from the U.S. Food and Drug Administration is asking 14 companies to justify offering their consumer-oriented genetic tests without the agency's approval.

During testimony before a Congressional committee, the Government Accountability Office unveiled a report that found identical DNA samples sent to four companies it investigated (23andMe, Decode Genetics, Pathway Genomics, and Navigenics) yielded differing results about the sample donor’s risk of developing certain disease.

A written report of the testimony, offered before the subcommittee of the House Committee on Energy and Commerce, featured the straight-shooting subtitle, “Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices.”

Phone calls placed by GAO representatives posing as fictitious consumers to one unidentified company offered up misleading advice, suggesting the tests are diagnostic. Clips of the calls, available on YouTube, featured gems like this:






Fictitious consumer: “So, if I’m at high risk does that mean I’ll definitely get breast cancer?”

Company representative: You... you'd be in the high risk of, you know, pretty much getting it.”

Another unidentified company the GAO called told its fictitious consumer that “genes are considered now not to be the source of our biology. They’re a symptom.”

“The problem with these marketing practices is that it is not clear today whether the exciting scientific developments in human genetics research actually transfer into ways to improve and individualize medical care,” warns Energy and Commerce chairman, Rep. Henry Waxman, who has spearheaded the House’s evaluation of the industry.

Ashley Gould, general counsel for 23andMe, testified at the same hearing in which the GAO presented its finding, saying that consumers are empowered by the information provided by direct-to-consumer tests and do not, in the company’s experience take “rash or unconsidered actions” based on that information.

On the regulatory front, the Mountain View, California is company is making its own proposal to the FDA. “We believe the current regulatory landscape is ready for improvement,” says Gould.

Navigenics too expressed interest in shaping the creation of regulation for the tests, which from the tenor of their testimonies, it and other leading test providers seem to view as inevitable, through the creation of an advisory committee.

“A major hurdle for us and other test developers has been the lack of clarity about the process,” says Vance Vanier, Navigenics’ president and CEO.

As for Pathway, the San Diego company that set off government alarm bells when it said it would distribute its genetic tests through Walgreens stores way back in May: David Becker, the company’s chief scientific officer says that "Pathway feels that bona fide genetic testing companies such as ours would benefit from a stable regulatory environment.”

The full text of the hearing on direct-to-consumer genetic testing and the consequences to the public health is available here.

The GAO report, “Direct-To-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices” is available here.