November 25, 2013

FDA Was Right To Block 23andMe

A few techno-libertarians are up in arms over the FDA’s letter warning the genetics company 23andme to stop selling its personalized genome services kit.

By Christine Gorman

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This article was published in Scientific American’s former blog network and reflects the views of the author, not necessarily those of Scientific American

A few techno-libertarians are up in arms over the FDA's letter warning the genetics company 23andMe to stop selling its personalized genome services kit. But a quick search of the Food and Drug Administration's admittedly user-unfriendly website shows federal regulators have been targeting various low-cost genetic testing ventures to provide the necessary analysis that goes along with a proper genetic screening for at least the past three years.

At present, getting raw data about your personal genome is worse than useless, as Nancy Shute pointed out in a Scientific American article that I edited back in 2012. "[E]ach individual’s genetic readout must be compared with lots and lots of other people’s readouts for doctors to understand which genetic patterns are important indicators of disease and which can be safely ignored," she wrote.

Shute further quoted Euan A. Ashley, an assistant professor of cardiology at the Stanford University School of Medicine as saying, ' "Generating the sequence now is fast and cheap. . . But the analysis? Wow. That’s not going to be fast, and that’s not going to be cheap.' "

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Using home gene kits to imagine where your ancestors might hail from is one thing. That's basically the 21st century equivalent of looking up your horoscope--entertaining but not really a matter of life and death. Cheap sequence data from 23andMe and other gene testing companies has much greater potential to harm without the proper interpretation of the results, which is still quite difficult and expensive in most cases.

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