FDA Smacks Down Home Genetic Testing Kits

Letter tells 23andMe to stop marketing kit immediately
By Kevin Spak,  Newser Staff
Posted Nov 26, 2013 9:01 AM CST
FDA Smacks Down Home Genetic Testing Kits
This image provided 23andMe shows the company's logo.   (AP Photo/23andMe)

The FDA has ordered 23andMe to "immediately discontinue marketing" its genetic testing kits, saying that the company has repeatedly failed to prove the product actually works. The Google-backed company offers mail-in genetic testing, which it promises can reveal your risk for various health conditions and drug allergies. In a sharply-worded warning letter addressed to co-founder and CEO Anne Wojcicki, the FDA says it fears false positives could cause consumers to undergo unnecessary procedures, while false negatives could make them miss actual warning signs.

The FDA says it's had "more than 14 face-to-face teleconference meetings" and "hundreds of email exchanges," with the company, and provided "ample detailed feedback" on what it must do. But "we still do not have any assurance that the firm has analytically or clinically validated the [test] for its intended uses." The company has 15 days to respond, and has released a statement saying it realizes it hasn't "met the FDA's expectations regarding timeline and communication." The case is being carefully watched as a sign for how the FDA will deal with genetic testing, experts tell the Washington Post. (Read more 23andMe stories.)

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