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23andMe Fallout

The US Food and Drug Administration issued a letter Friday to direct-to-consumer genetic testing company 23andMe telling it to stop marketing its spit kit and genome service to consumers until it receives authorization from the agency.

In its rather testy letter, FDA notes 23andMe filed for 510(k) clearance in 2012, but that the company has not adequately addressed some of the agency's questions regarding validity of the test for some of its intended uses. Additionally, Alberto Gutierrez, the director of the Office of In vitro Diagnostics and Radiological Health at FDA, writes that company's intended uses have expanded beyond the ones initially discussed with FDA.

“FDA is concerned about the public health consequences of inaccurate results from the [Personal Genome Service] device,” the letter adds.

In addition, Elizabeth Mansfield, the director of personalized medicine, tells the New York Times that FDA is concerned about how 23andMe is interpreting its results medically.

In a short statement, 23andMe acknowledges the warning letter. "We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission," the company says. "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."

In the past, 23andMe has portrayed its service as a way to democratize health and help people make lifestyle changes.

Reactions to this warning letter run the gamut from denouncing government interference in people's access to their own genetic information to applauding the effort to ensure the accuracy of such tests.

At Reason's Hit & Run blog, Ronald Bailey calls FDA's move "outrageous."

"The FDA bureaucrats think that they know better than you how to handle your genetic information," Bailey says.

And at his Gene Expression blog, Razib Khan exhorts his readers to download their 23andMe results. He also likens this to the Recording Industry Association of America's takedown of Napster.

Still, Khan adds in a post at Slate that, no matter what, people will eventually receive their genetic data. "The institutions designed to protect the public from fraud need to think more about empowerment rather than engaging in fiat paternalism," he argues.

Misha Angrist, a assistant professor at the Institute for Genome Sciences and Policy at Duke University, tells the Times that FDA's worry about someone acting solely on their 23andMe results for something as serious as, for instance, a mastectomy is "borderline absurd." People, he says, would get a follow-up test.

Additionally, a petition at We the People has been started to try to undo the FDA warning, and it argues that "[t]he price of over-regulation is lengthy delays in potentially life-saving medical innovations."

Daniel MacArthur notes in a tweet that the petition "undermines itself by using term 'potentially life-saving diagnostic kits'" in its title.

Others welcome further oversight. Duke's David Goldstein tells the Wall Street Journal that genetic tests can increasingly uncover potentially serious mutations that affect people's decisions about, for example, whether to have children. "It's more actionable information now. And we're all getting nervous. In that context I welcome what the FDA has done," he says.

Further, Johns Hopkins University's David Valle tells the Journal that companies that sell genetic tests "should be willing to undergo scrutiny of their laboratory processes."

And at Forbes, Matthew Herper wonders whether not engaging with FDA will backfire on 23andMe. He points out that the FDA letter says that the agency hasn't heard from 23andMe since May, and in that time, 23andMe has launched a marketing campaign.

"Either 23andMe is deliberately trying to force a battle with the FDA, which I think would potentially win points for the movement the company represents but kill the company itself, or it is simply guilty of the single dumbest regulatory strategy I have seen in 13 years of covering the Food and Drug Administration," Herper says.

23andMe has about two weeks to respond to the letter from FDA.

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