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FDA Orders Halt of 23andMe Marketing and Sales

The New York Times reports on an FDA crackdown on a genetic test offered directly to consumers by Google-backed company 23andMe. The test, called the Personal Genome Service (P.G.S.), “analyzes the DNA in a saliva sample to tell consumers, among other things, whether they might be at a higher or lower risk of developing certain diseases.” The FDA, however, is concerned over whether “the firm has analytically or clinically validated the P.G.S. for its intended uses.” One worry, in particular, is that the test may provide false positives for a gene mutation indicating that a woman has a high risk of breast cancer and that this may lead to unnecessary mastectomies. Additionally, the FDA reports concern that the results may lead patients to make medical decisions without first consulting a doctor.

Read it in The New York Times.