Genetic Test Service 23andMe Ordered to Halt Marketing by FDA

The Wall Street Journal (online registration required): The U.S. Food and Drug Administration ordered 23andMe Inc. to stop marketing its $99 mail-order genetic test, citing the risk that false results could cause consumers to undergo unnecessary health procedures including breast surgery.

The FDA said in a Nov. 22 warning letter to 23andMe Chief Executive Anne Wojcicki that the company doesn't have the proper marketing clearance to sell the DNA testing kit, and 23andMe hasn't sufficiently worked with the agency to secure such approval. The FDA said it hasn't heard from the...

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