Direct-to-consumer genetic tests, including those intended to predict celiac disease risk, have "no practical use to consumers” according to a federal investigation reported by
CNN yesterday.
The Government Accountability Office purchased 10 tests from four companies and submitted the tests using DNA samples from five donors. Test results for 15 diseases were analyzed and found to yield contradictory information, even among donors with identical DNA. In some cases, conflicting results were identified within the same report.
The investigation noted that each company uses different genetic markers, which could contribute to the differences in results. According to genetics experts, “there are too many uncertainties and ambiguities in this type of testing to rely on any of the results,” the report added.
Investigators have reported the findings to the FDA, National Institutes of Health and FTC. The FDA, FTC and Centers for Disease Control and Prevention (CDC) have previously issued warnings about the claims made by direct-to-consumer genetic testing companies. The FDA and CDC advise individuals to seek testing at a specialized laboratory and have the results interpreted by a trained doctor or counselor.
The full report is available
online.