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FDA tells 23andMe to stop offering personal genetics test

MIT Technology Review, November 26, 2013
On Friday, the U.S. Food and Drug Administration told 23andMe CEO Anne Wojcicki that her company "must immediately discontinue marketing the [Personal Genome Service]." For $99, 23andMe will analyze the DNA in a saliva sample for genetic traits related to ancestry information, physical characteristics, disease risk, and drug response. The health-related information is what concerns the FDA. The agency says that customers may make health decisions such as prophylactic breast removal surgery as a result of 23andMe's report on their genetic risk for breast cancer. The problem, writes the FDA, is that the company has not provided the data to prove that the tests work, so consumers may make major health decisions based on faulty results.