Government Sting Operation Finds Problems With Personal Genetics Tests
The summer of our government’s discontent (with personal genetics tests) continues. Yesterday an investigator with the Government Accountability Office reported back to Congress on its undercover investigation of the tests on the market, saying that testing the DNA of GAO staffers returned frequently contradictory and confusing answers.
“Consumers need to know that today, genetic testing for certain diseases appears to be more of an art than a science,” said GAO investigator Gregory Kutz [CBS News].
Here at 80beats, we’ve gone over some of the potential problems with these tests. DISCOVER blogger Ed Yong covers them in great detail in a post he wrote this week after getting his genes tested by 23andMe, including the dearth of data appropriate for interpreting results if you’re of Asian rather than European descent, and deciding whether to peek into the data that says whether you have a much higher than average risk for Parkinson’s disease.
The federal government began to worry about the same things this summer after Walgreens announced plans to sell tests by Pathway Genomics in its drug stores. Then, last month, the FDA announced that it intended to regulate these tests, whereas before they existed in a cloud of regulatory uncertainty—Pathway had told Walgreens the tests didn’t require the government’s OK. Congress got in on personal genomics, too, which led to this GAO investigation.
The GAO report suggests the companies still have a long way to go in drawing accurate conclusions. The agency submitted DNA samples from five staffers to four different genetic testing companies. When considering the same disease, the companies’ results contradicted each other nearly 70 percent of the time, according to GAO. In response to the same patient’s DNA, one company claimed he was at above-average risk for prostate cancer, a second said he was below average and two others said his risks were average [AP].
The FDA is holding meetings this week, trying to decide how it will regulate the tests.
Image: flickr / nosha
- FDA: We’re Going to Regulate Those Personal Genetics Tests, After All
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- Walgreens’ Genetic Tests on Hold, Under Congressional Investigation
- 5 Reasons Walgreens Selling Personal DNA Tests Might Be a Bad Idea
- Genetic Testing Coming To a Drugstore Near You