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GAO's Stealth Report Attacks 'Deceptive' DTC Genetics

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The Government Accountability Office said today that direct-to-consumer genetics companies may be "misleading" consumers about what their services do and engaging in deceptive marketing practices.

Following an investigation it conducted of some of the players in the industry, the GAO said that the tests offered by these types of firms currently "are of little or no use."

The GAO investigation used fictitious customers to use the services of DTC genetics companies including Navigenics, 23andMe, and Pathway Genomics, and it investigated marketing practices, compared testing data for disease risks from different companies, and compared the companies' customer support services. In total, it purchased 10 tests each from four companies, for $299 to $999 per test, it said.

The GAO released the report today as part of its testimony on Capitol Hill at a hearing on DTC genetics tests that included representatives from the US Food and Drug Administration, three DTC genomics companies, and elsewhere.

The GAO found that people who donated DNA samples to the DTC genetics companies, including GAO employees, often received varying disease risk predictions from the four companies, which shows that the firms pulled contradictory results from identical DNA samples.

One donor, for example, was told that he was at below-average, average, and above-average risk for prostate cancer and hypertension. GAO DNA donors also received disease predictions that conflicted with their actual medical conditions, including a donor who had an irregular heartbeat — and received a pacemaker for the condition 13 years ago — but was told he was at decreased risk for such a condition.

The investigation also found practices in customer relations that were misleading or unethical, including a customer service representative who told a customer that it was okay for her to surreptitiously submit her fiancé's DNA sample for analysis without his knowledge.

"Posing as consumers seeking information about genetic testing on the Internet and through phone calls and face-to-face meetings, we found that 10 of the 15 companies we investigated engaged in some form of fraudulent, deceptive, or otherwise questionable marketing practices," the GAO report said. "For example, at least four companies claimed that a consumer's DNA could be used to create personalized supplements to cure diseases."

None of the companies involved were able to provide GAO's fictitious African American and Asian donors with complete test results, but they did not explicitly disclose their inability to do this before the purchase.

In spite of the varying results from the companies in disease risk prediction, each of the companies claimed that their results were more accurate than the others', according to the report.

GAO presented the report today to the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations. At the same hearing a representative from FDA's Center for Devices and Radiological Health was scheduled to talk to the committee about its decision to notify 14 DTC genetic testing companies that their services are medical devices that should require FDA clearance or pre-market approval to be sold legally.

The DTC genetics providers named in the GAO's report were not aware of that office's investigation or findings until today at the House subcommittee meeting, and none of them have yet responded to the allegations.

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