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GAO 'Sting' 'Doesn't Bode Well' for DTC Industry

This post has been corrected to reflect that 23andMe's General Counsel is Ashley Gould.

The United States Government Accountability Office dealt a blow to several direct-to-consumer genetic testing firms yesterday during testimony delivered to the House of Representatives Committee on Energy and Commerce's Subcommittee on Oversight and Investigations. Gregory Kutz, managing director of Forensic Audits and Special Investigations, issued a 33-page report outlining his group's investigation — which some have dubbed a "sting" operation — of the "deceptive" marketing claims made by four DTC firms. Kutz's team sent 10 saliva samples to each of the four companies — not named in the report — from volunteer donors, and submitted along with them both accurate and fictitious health information. The GAO team received "test results that are misleading and of little or no practical use," and found "10 egregious examples of deceptive marketing, including claims made by four companies that a consumer’s DNA could be used to create personalized supplement to cure diseases," according to the report. A customer service representative at one of the companies told a GAO volunteer that "an above average risk prediction for breast cancer meant she was 'in the high risk of pretty much getting' the disease."

Our sister publication GenomeWeb Daily News has coverage of yesterday's meeting here. The GAO has also posted a video containing taped responses to its undercover customer inquires and a summary of its findings here.

According to the Wall Street Journal's health blog, DTC firm executives "said they believed the field needed some common standards." Pathway Genomics CSO David Becker said that "the company is requiring the test to be sold through a doctor until the firm works out all the regulatory issues with FDA," the WSJ reports. Ashley Gould, director of 23andMe's legal affairs, stressed the distinction between "risk-prediction models" and diagnostic tests.

Maureen Martino at Fierce Medical Devices says that "the GAO's finding doesn't bode well for consumer genetic testing industry." Genetic Future's Daniel MacArthur says the testimony represents a "sad day for personal genomics," and suggests that "this is far, far bigger than personal genomics. …The suffocating effects of this power-grab will be felt well beyond our little circle of personal genomics aficionados." Dan Vorhaus at Genomics Law Report provides an in-depth look at the meeting proceedings, and says that "obviously, much depends on where the regulatory and legal landscape moves from here. …No matter what comes next, over the long term I continue to believe … that there is considerable demand for direct consumer access to personalized genetic information."

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