Investigation: take home genetic tests inconsistent

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An undercover investigation conducted by the U.S. Government Accountability Office (GAO) finds that take-home genetic test kits yield inconsistent results and provide little useful guidance for health decisions. This past May Walgreens pharmacy halted plans to sell over-the-counter genetic test kits after the U.S. Food and Drug Administration said that the kits had not been proven safe or effective, and a month later the federal oversight agency determined that at-home genetic tests were in fact medical devices and should be subject to regulation. As Reuters reports, this week the FDA held a conference aimed at charting a course for regulation, and Gregory Kutz from the GAO testified before a Congressional panel investigating the genetic test kits about the grim findings of the undercover inquiry.

As part of the investigation, the GAO recruited five donors and purchased 10 genetic test kits from four different companies that cost between $299 and $999 each. For each donor, the agency sent two samples per company — one that included accurate information about the person’s race, medical history and other factors, and one that offered inaccurate background. When they got the test results, they consulted genetics experts about their accuracy and usefulness. In a summary that prefaces the 33-page GAO report (PDF), which was released publicly yesterday, the authors offer a review of the findings as scathing as it is direct:

“GAO’s fictitious consumers received test results that are misleading and of little or no practical use.”

In fact, donors often received totally different results from the different companies, did not provide full test results for people from certain ethnic backgrounds — which they didn’t advertise before the fact — and made claims about predictions and accuracy that experts dismissed as both absurd and misleading. As Reuters highlights, speaking to the Congressional panel, Kutz said the marketing claims were inflated and inaccurate and the inconsistency in findings across the companies undermines the tests’ credibility. He concluded that, ultimately, the genetic test results were “misleading and of little use to consumers.”