Genetic Testing

Consumer Genetic Tests Win FDA Approval

The FDA has allowed the first direct-to-consumer genetic testing to come to market. The company 23andMe is now allowed to advertise it’s genetic health risk tests for ten diseases, including Parkinson’s, Celiac, Gaucher, and late-onset Alzheimer’s. Previously, 23andMe had been ordered to stop selling this service due to concerns that consumers might have been ill-prepared to make sense of the data without a medical professional. The ruling allows for special controls “assuring the tests’ accuracy, reliability and clinical relevance” and does not apply to diagnostic testing. Unaddressed are privacy concerns raised by 23andMe’s harvesting of vast amounts of DNA data which it shares with drug companies, concerns exacerbated by the fact that founder Anne Wojcicki was married to Google’s Sergey Brin. —ML

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