A new report from the US Government Accountability Office on direct-to-consumer genetic testing companies came out yesterday, and you don’t have to look much further than the title to guess what they found: “Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices”. In an undercover operation, government investigators bought genetic tests from four companies. They sent the companies two samples from each volunteer donor &mdash one with a factual medical history and profile, and one where details of race, age, and medical history were fictitious.
The same DNA sample would bring up different risk predictions amongst all four companies, probably due to the fact that different companies focus on different genetic markers. Risk predictions often conflicted with donors’ family medical history and, in some cases, actual medical conditions: one donor, who had a pacemaker implanted to treat irregular heartbeat, was told he had little risk of developing heart problems. None of the companies were able to provide complete test results for the specimens from volunteers assigned fictitious Asian or African ancestry, apparently due to a lack of data on these populations; but companies failed to explicitly state these limitations before the investigators purchased the tests. Follow-up consultations often provided generalized advice, such as quitting smoking to reduce the risk of heart attack.
The GAO also called 15 genetic testing companies to investigate their marketing practices. While posing as consumers, investigators were treated to a number of fraudulent claims, such as assurances from one company that its personalized tests and products would “repair damaged DNA”, and another falsely claiming its supplements were endorsed by US Olympic swimmer Michael Phelps.
None of the companies are identified by name, but the report does refer to one company whose invention was named Time magazine’s 2008 “Invention of the Year” &mdash an honor which went to 23 and Me’s spit cup DNA test. Over the past two months, the US Food and Drug Administration has sent letters to nearly 20 consumer genetic testing companies, including 23 and Me, requesting documents to prove the medical validity of their tests, which the FDA is considering regulating as medical devices.
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