Mail-in Genetic Testing Unreliable, Misleading

Direct-to-consumer genetic testing promises vital insight into your own DNA. But these mail-order spit tests are rife with mistakes and misleading information, according a recent report by the Government Accountability Office (GAO).

This morning, Gregory Kutz, managing director of forensic audits and special investigations at the GAO, shared with a congressional committee the results of his investigation into companies that provide direct-to-consumer genetics tests that require a saliva sample from the customer and provide an assessment of the person's genes.

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Using DNA from five donors, undercover investigators sent out two DNA samples from each donor -- one with factual descriptions of donor age and ethnicity, the other with fictional -- to four companies offering consumer genetic testing.

Navigenics, 23andMe, and Pathway Genomics, three of the companies evaluated by the report, were present for Kutz' testimony for rebuttal. The remaining company, deCODE Genetics, was not there and did not offer a prepared statement to the committee.

The results, as well as the interpretation of the results provided by the company, were "misleading and of little or no practical use to consumers," Kutz told the House Energy and Commerce Subcommittee on Oversight and Investigations, noting that results from some companies directly contradicted those from others.

"Sixty-eight percent of the time our donors received different predictions for the same disease," Kutz told the subcommittee.

Nancy King, co-director of the Center for Bioethics, Health, and Society at Wake Forest University, says that it is not surprising that the results would be so varied given the lack of standards of interpretation for genetic testing:

"We're taking things that are very difficult to interpret. Except in extremely rare circumstances, when you're found to have a gene associated with [for example], a sort of cancer, that background risk is pretty low. What adding to that [risk] means, is really up for grabs."

Misleading Results, Misguided Information

The results received by the GAO's fictional consumers were not only plagued by contradictions but were supplemented by misguided information by company representatives, Kutz told the subcommittee.

One donor was even told that he had average, below average, and above average risk for prostate cancer and hypertension. Another was told that he was at low genetic risk for atrial fibrillation, even though he had been implanted with a pacemaker for atrial fibrillation 13 years ago.

Dr. Hope Northrup, a geneticist at Children's Memorial Hermann Hospital in Houston, Texas, said in defense of the test that many health conditions -- heart conditions included -- cannot be entirely chalked up to genetics alone. In other words, factors like lifestyle choices and environmental factors can play a strong hand.

"It doesn't mean that the test was wrong, it simply means that the test gave a very small piece of information," she said. "I just think that the public needs to realize with a caveat that they may not fully understand the information that they are being provided and don't get upset, but seek some help trying to figure out the proper answer."

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