FDA orders 23andMe to halt sales

FDA ordered personal genetics company 23andMe Inc. (Mountain View, Calif.) to immediately discontinue marketing its Personal Genome Service (PGS). FDA's Nov. 22 warning letter said 23andMe is marketing its PGS for "medical device uses," for which the product does not have FDA clearance or approval.

As an example, FDA said 23andMe is marketing its PGS for "assessments for BRCA-related genetic risk and drug responses," which the agency said is "particularly concerning" because of the potential consequences of false positive or false negative results. ...