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Personalized DNA testing kits should be regulated as medical devices, the FDA says

June 11, 2010 |  5:03 pm

The U.S. Food and Drug Administration has decided that the personalized DNA tests sold by companies like 23andMe are medical devices subject to government regulation, and the federal agency says the tests must be vetted by regulators if they are to remain on the market.

Navigenics Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA’s Center for Device and Radiological Health, sent letters on Thursday to 23andMe, Navigenics, DeCode Genomics, Knome and Illumnia telling the companies that they should have submitted their tests to the FDA before offering them for sale to the public. According to the letters, the tests qualify as medical devices because they are:

intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or [are] intended to affect the structure or function of the body.

For instance, Gutierrez told reporters, a test might tell a woman that she has a higher-than-average risk of developing ovarian cancer, and that information might prompt her to have her ovaries removed. But the accuracy of these tests is an open question, and many genetics experts say their predictive value is dubious at best.

In the letters (which were posted on the FDA’s website Friday), Gutierrez asked the companies to take “prompt action” and schedule meetings with the FDA to find out what they should do to win regulatory approval – or to make their case that the FDA is wrong.

That’s what Navigenics intends to do, according to this post on the company’s blog:

We believe our services comply with all existing federal and state regulations, and look forward to continuing our dialogue with the FDA to ensure transparency and the optimal use of genetic information as it applies to personalized medicine.

23andMe took a similar position, arguing that people have a right to know their genetic information and that the FDA should not stand in their way.

While the companies and regulators hash things out, the test kits will be able to stay on the market (they are sold primarily to consumers via the Internet). Gutierrez said that such a drastic move would have been unfair considering that the FDA had not made its views explicit until now.

But the move is part of a recent trend at the FDA to crack down on DNA tests offered directly to consumers. Last month, the Walgreens drug store chain backed away from a plan to sell a consumer-oriented test kit made by Pathway Genomics in its stores after the agency said the kit lacked FDA approval.

-- Karen Kaplan

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Photo: This chip, which contains the DNA of a Navigenics customer, is a medical device subject to regulation from the FDA, according to the agency. Credit: Steve Yeater

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