FDA Stops 23andMe

November 26, 2013 by  

FDA Stops 23andMe, — In a harsh warning letter made public Monday, the U.S. Food and Drug Administration ordered Google (GOOG)-backed 23andme to stop selling its widely used genetic test to consumers because the company has failed for four years to prove the product is medically useful, and the agency fears it could endanger lives.

In a statement, the company acknowledged that “we have not met the FDA’s expectations” for the test, which costs $99, and it said that it was committed to working with the FDA to address its concerns. But the action is a significant setback for the company, whose CEO, Anne Wojcicki, is married to but separated from Google co-founder Sergey Brin and which in December said it received more than $50 million from Brin, Google Ventures and other sources.

The warning letter comes as regulators have struggled for years with how to regulate the burgeoning field of personalized medical testing, which has prompted government investigations and aroused deep concerns from some health experts.

The letter notes that the FDA has worked with 23andMe since 2009 to help it comply with governmental requirements regarding the safety and effectiveness of its “Personal Genome Service,” which tests people’s saliva for genetic indications of 254 disease conditions and other potential health risks.

The agency said it has had “more than 14 face-to-face and teleconference meetings, hundreds of email exchanges and dozens of written communications” with the company. However, it added, “We still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses.”

Some uses for the test “are particularly concerning,” the FDA said, “because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications.” A false-positive for breast or ovarian cancer, for example, “could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist,” the FDA said.

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