The U.S. Food and Drug Administration has asked 23andMe to stop marketing its genetic tests to consumers. In a Nov. 22 letter, the agency warned the company that it has neither marketing clearance nor approval to make the tests available, and is therefore in violation of the Federal Food, Drug and Cosmetic Act. Specifically, the FDA voiced concern about the "public health consequences of inaccurate results from the PGS [personalized genomic sequencing"] device."
The agency noted that despite the many discussions — "more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications" — that they have had with the company to ensure safety and proper use of the service, “we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions.”
In a public statement, 23andMe acknowledged the receipt of the letter from the FDA, adding: “We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
The company was given 15 working days to respond to the warning letter.
See our previous coverage of personalized genome sequencing: http://bit.ly/17Qydaa.