Gene test users largely satisfied, survey finds

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Most people who have used direct-to-consumer genetic tests bought them to improve their health and say they found the tests easy to interpret, but some do not fully understand their results, U.S. researchers said on Friday.

A team led by David Kaufman of Johns Hopkins University did a random online survey of 1,048 people who had been customers of one of three genetic testing companies—Decode Genetics, Navigenics Inc and 23andMe Inc, which is backed by Google.

Overall, 77 percent of participants said they got tested to improve their health and 58 percent said they learned something new that would improve their health, Kaufman told the American Society of Human Genetics meeting in Washington. Such tests look for genetic predisposition to conditions like diabetes and heart disease.

Direct-to-consumer genetic tests have raised concern among U.S. health regulators who worry people will make health decisions based on inaccurate or inconsistent results.

In July, an undercover probe by the Government Accountability Office showed people who sent off their saliva to DTC testing companies might get a different answer to the same genetic question, depending on which company they used.

A U.S. Food and Drug Administration official said in July the agency would soon regulate the sale of the tests.

For more than three decades, the FDA has chosen not to regulate simple diagnostic tests developed in individual laboratories. It does regulate tests considered medical devices—tests used to diagnose or prevent disease.

People who try the unregulated direct-to-consumer tests tend to be better-educated and wealthier than the general public and are often motivated by curiosity about their own health and ancestry, the researchers found.

Testing companies say the tests are useful for modifying bad habits that could contribute to future health risks, especially if someone is predisposed to disease.

GENERAL SATISFACTION

According to the survey, more than a third of people said they were being more careful about their diet as a result of getting the tests, 15 percent had changed their medications or diet supplements and 14 percent were exercising more.

Some 88 percent of people said they were generally satisfied with the testing experience, and 90 percent said their curiosity was satisfied.

Most of those surveyed—88 percent—said their results were easy to understand. Among the remaining 12 percent who did not, half said they were not satisfied with their test results.

To see how well people interpreted their results, the group asked people in the survey to review two test results provided by the companies and asked them questions about them. They found 4 to 7 percent of people got the results wrong.

Kaufman said long-term follow-up of direct-to-consumer testing was needed to evaluate how they affect people’s health.

FDA official Dr. Jeffrey Shuren said in July the agency had been watching DTC testing companies for some time, but grew concerned when Pathway Genomics announced a pact with Walgreen Co in April to distribute its tests through its 6,000 neighborhood pharmacies.

Pathway has since stopped selling its tests to consumers.

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By Julie Steenhuysen

CHICAGO

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