Gene tests do not cause distress: U.S. researchers

(Reuters) - Most people who used a commercially available genetic testing kit made by Navigenics were not traumatized by their results, as some critics had feared, U.S. researchers said on Wednesday.

The results did not cause people to change their lifestyles through diet, exercise or other changes to reduce their risks either, said a team led by Dr. Eric Topol of the Scripps Translational Science Institute in San Diego, whose study appears in the New England Journal of Medicine.

"They did no harm and it's debatable about how much good they do," Topol said of the tests in a telephone interview.

The study is the first to look at the impact of these tests, and the findings address concerns that consumer genetic tests could distress people who learn they are at risk for diseases like Alzheimer's or diabetes.

In July, the U.S. Food and Drug Administration said consumers may not know what to do with information from genetic tests taken without a doctor's guidance.

None of the tests sold to consumers were approved by the FDA, but the agency said last summer it was gearing up to regulate them. Companies that make the tests include Navigenics Inc, Pathway Genomics Corp, and 23andMe Inc, which is backed by Google Inc.

"These tests have been harshly criticized by the medical community and government agencies, but until now there were no data," Topol said in a statement.

His team studied 2,000 adults who took the Navigenics Health Compass, which looks for genes that raise the risk of more than 20 conditions such as diabetes, obesity, heart attack and some forms of cancer.

Participants filled out an online questionnaire before the test detailing their level of anxiety, exercise and eating habits as well as medical screening practices and other behaviors. They filled out another questionnaire five to six months after they got their results.

More than 90 percent of people who completed the follow-up questionnaire had no test-related distress.

And while companies that sell the tests often claim that they can help people make positive lifestyle changes, the team saw no evidence of that.

But Topol said many people in the study said they were thinking about getting a screening test.

About 10 percent of participants discussed their results with a genetic counselor -- which was offered for free -- and 26.5 percent said they shared their results with a doctor.

Dr. Vance Vanier, chief executive of Navigenics, said the study shows direct-to-consumer genetic testing does not cause undue anxiety. He was encouraged to find that 25 percent of people who shared the results with their doctors made lifestyle changes, suggesting the tests could be a tool for doctors to encourage healthy behaviors.

The study did not look at whether the results were accurate or meaningful. A General Accounting Office probe in July found genetic tests sold by four different companies produced inconsistent results.

Navigenics provided the genetic tests, but had no other role in the study, which was funded by the National Institutes of Health.