Regulators Take Aim at Genomics

Here’s the first part of my column on the recent Congressional investigation into the genomcs industry:

The genomics industry, which provides reports about disease risk, ancestry, and drug reactions based on one’s DNA, came under fire last week as a Congressional Committee held hearings and the Government Accountability Office (GAO) released an unscientific “study” of the sector.

According to undercover discussions with genomics firms, the GAO reports that “fictitious consumers received test results that are misleading and of little or no practical use.” The agency admits, however, that it “did not conduct a scientific study but instead documented observations that could be made by any consumer.”

The GAO’s “sting” operation on this nascent field looks more like a witch hunt, given that it lumped in legitimate testing companies with others that are not.

In one instance, a company representative said that it would be OK to send in someone else’s saliva to be tested. As the GAO points out, that practice is already restricted in 33 states, so this seems more like a matter of enforcement.

The GAO’s report is a tricky way of attempting to perturb the public about genetic testing, but it also raises a key question: Why haven’t government regulators disciplined the companies that are clearly breaking the already-established rules?

The GAO also blasts the genomics industry for providing different results for the same DNA, but when dealing with something as complicated as the human body, there often are valid scientific reasons for variation. As 23andMe points out on its blog, testing is not yet standardized, and some companies “employ different statistical models for making risk estimates; they establish different criteria for the inclusion of associations in their reports; and new associations are being discovered at a faster rate than companies’ development cycles.”

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Read more here: http://www.technewsworld.com/story/70499.html

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Regulators Take Aim at Genomics