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About a month ago, MNB drew your attention to a fascinating must-read in Fast Company about a company called 23andMe, an at-home genetic testing startup founded by the company CEO, Anne Wojcicki, and partially funded by Google.

But now, the Wall Street Journal reports, the US Food and Drug Administration (FDA) has ordered the company to stop marketing its $99 mail order kit, "citing the risk that false results could cause consumers to undergo unnecessary health procedures such as breast-cancer surgery." And, the FDA said it could trace stronger action - including the seizing of product - if the company does not act appropriately.

The story notes that the warning "follows a debate that has grown as hundreds of thousands of people have turned to direct-to-consumer genetic tests for clues about disease risk and ancestry. Proponents say people have a right to direct access to their genetic data. But some public-health experts worry about inaccurate results or the misuse of data outside of the guidance of doctors and genetic counselors."

The company said that the warning seems to have in part resulted because it has not met the FDA's "expectations" when it comes to communicating in a timely fashion. And, it promised to work to meet FDA concerns and strengthen its quality-control procedures.
KC's View:
Companies marketing such products have to make sure they toe the line when it comes to regulatory issues, but I have to admit that I wonder about the specific objection that such test and false positives could lead to unnecessary surgeries. Even if you discovered a genetic issue, wouldn't you have to go to a doctor for further testing and treatment? It isn't like at-home DNA testing is the last word … it is just a warning sign that is designed to help people be aware of potential problems and act on them, through diet and exercise as much as surgery.