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Home Genetics Tests Mislead, Misinform

Genetic tests marketed directly to consumers provide conflicting and misleading information that is “of no practical use” according to a new report from the General  Accounting Office.

In their investigation, the GAO purchased the tests, costing from $299 to $999 each, from four different companies.  The same donors submitted two DNA samples to all four companies — one with real and one with fictitious medical information.

Information received from testing was contradictory and didn’t jibe with donors’ real medical conditions.

One man was told that he had below-average, average, and above average risk for hypertension and prostate cancer.  One donor who already had colon cancer was told he was at “average risk” for the disease.

Another donor, who had a heart pacemaker, got a result that said he had a decreased risk for the condition that was being treated with the pacemaker.

The GAO found that advertising for the tests was deceptive and that testing was often used as a basis to sell expensive nutritional supplements.

One of the genetic experts consulted by the GAO said, “

The fact that different companies, using the same samples, predict different directions of risk is telling and is important. It shows that we are nowhere near really being able to interpret [such tests].

In addition to analyzing conflicts in reports of DNA samples, the GAO also looked at advertising claims for the tests.  They found them misleading, promising such things as:

  • Four companies  said that a consumer’s DNA could be used to create personalized supplement to cure diseases.
  • Two companies claimed that their supplements could “repair damaged DNA”.
  • Two companies promised to tell parents what sports their children would excel in based on DNA.

After getting results, the GAO make undercover calls to each of the four companies for health advice based on the tests.  In many cases that advice was incomplete, confusing, or wrong.  Only one company has a certified genetics counselor on staff.

In follow-up consultations a donor who was told he was at high risk for colon cancer was told by one company’s “expert”

While he should become familiar with the symptoms such as blood in the stool, there was not much else he could do because  “colon cancer is quite silent.”

You can read more about the GAO’s investigation and findings in the report online: Direct-To-Consumer Genetic Tests: Misleading Test Results Are Further Complicated by Deceptive Marketing and Other Questionable Practices

Gregory Kunz brought the GAO report to the House of Representative  in testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives on July 22, 2010.

Also testifying were representatives from three of the direct-to-consumer genetic testing companies, genetics experts, and representatives from the FDA’s Center for Devices and Radiological Health.

The FDA is planning to consider regulation of the tests, saying that they appear to meet the requirements for “medical devices” which which are used to diagnose a disease or condition and/or to determine the state of one’s health in order to cure, mitigate, treat, or prevent certain medical conditions.

Emily P. Walker, Washington Correspondent for MedPage Today has written more about the hearing.

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