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23andMe Opens Up FDA Pathway For DTC Genetic Predisposition Tests

23andMe has made it full circle with at least 10 direct-to-consumer genetic predisposition tests gaining FDA go-ahead for testing services to provide information on an individual's risk for developing Alzheimer's, Parkinson's, and celiac disease, among others. The de novo classification comes three-and-half years after the firm's DTC genetic testing service was forced off the market by FDA, and two years after it was able to relaunch carrier-screening test services.

FDA cleared the way for 23andMe Inc.to launch the first FDA-validated direct-to-consumer intended to alert people of genetic predispositions to certain conditions with a de novo classification that allows marketing of DTC tests for 10 conditions, including Alzheimer's and Parkinson's, and establishes a pathway for the Mountain View, Calif., firm to launch new risk-predisposition tests without needing FDA review.

With the April 6 decision, 23andMe is preparing to launch its Personal Genome Service Genetic Health Risk tests for the...

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