23andMe CEO Responds to FDA Warning Letter

Published on November 27, 2013
by Peter Loftus and Ron Winslow

The head of genetic-test maker 23andMe Inc. responded to a Food and Drug Administration warning letter in a blog post Tuesday night, acknowledging the company was behind schedule in addressing FDA concerns but defending the accuracy and value of the company’s tests.

The FDA ordered the Google Inc.-backed company to stop marketing its $99 genetic test in a Nov. 22 letter, saying the company hadn’t secured marketing authorization and expressing concern that inaccurate results could lead consumers to undergo unnecessary health procedures such as breast-cancer surgery. The FDA said 23andMe hadn’t responded to numerous requests for more information, even as the company was launching a national television advertising campaign for the product, which analyzes genetic information from a person’s saliva for clues about disease risk and ancestry.

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