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Last Thursday, the Government Accountability Office presented Congress with a damning report on the consumer genetic testing industry, concluding many tests are “misleading and of little or no practical use.” Company leaders and some geneticists, responding via blog and twitter, have called the report one-sided and unscientific, citing concern it will do irreparable harm to the nascent industry. “There’s no question that the sheer scale and ferocity of this combined inquisition from the FDA and Congress will forever change the face of the personal genomics landscape,” writes Daniel MacArthur, a geneticist and author of the Genetic Future blog.

The Spittoon, a blog published by 23andMe, one of the companies named in the report, notes that “The GAO refused to discuss its concerns or its report with 23andMe, and now that the report is public and we have had a chance to review it, we are troubled and find the report is deeply flawed.”

One of the main criticisms is that the GAO did not name the companies in its report, thus lumping together the more reputable companies, which have generally gone to great length to explain the limitations of their testing, with the clearly charlatan ones, such as those selling supplements tailored to an individual’s DNA. “It conflates responsible companies offering scientifically valid products with small-time con artists,” writes MacArthur.

The report also largely failed to distinguish between useful tests, such as those that predict whether someone will respond to a particular drug, with those whose utility is still up in the air, including tests that predict risk of complex diseases, such as diabetes or heart disease. Misha Angrist, an assistant professor at the Duke University Institute for Genome Sciences & Policy and a participant in the Personal Genome Project (and who has written for Technology Review), points out in his GenomeBoy blog:

I found that learning my carrier status for a number of diseases, risk for late-onset Alzheimer’s, and genetic responses to a number of drugs to be useful. I found the ancestry information to be interesting and entertaining. Would I have paid $1000? No. $99? Yes. More than that? It depends on what I’d be getting. That’s why the GAO’s failure to distinguish among the companies, their pricing structures and their offerings is so unfortunate. The net result does not allow for any nuance whatsoever. Rather, if one accepts the GAO’s conclusions, there seems to be room for only one response: “Off with their heads.” If that’s the case, then consumer genomics will be driven underground and/or overseas. In my view, that would be a shame.

A major criticism in the GAO report was that different companies gave different predictions for disease risk based on the same DNA. The targeted companies agreed this needs to be improved. 23andMe, for example, has requested guidance from the FDA and NIH. Angrist suggests going a step further, noting that these conclusions should trigger;

… a meeting of the minds with a big tent full of experts to try to reach a consensus on interpretation for things like prostate cancer and hypertension; 2) removal of those conditions from their services in favor of, say, clearly useful and less contested things like carrier screening and pharmacogenomics; or 3) a serious downgrade of those results to “provisional” or “preliminary” status. The companies have no one to blame but themselves for these discrepancies, which, in my view, are the most damning aspect of the report and could have been avoided. I would urge them to pursue at least one of the three aforementioned options and get their ducks in a row.

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Tagged: Biomedicine, genome, personalized medicine, consumer genetic testing, goa

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