23andMe to Attend FDA Public Advisory Committee Meeting on Direct-to-Consumer Genetic Tests

Last summer, the Food and Drug Administration (FDA) indicated that it would be revising its regulatory guidelines pertaining to laboratory-developed tests (LDTs), and that direct-to-consumer genetic tests such as 23andMe’s Personal Genome Service® would potentially fall under that category. 23andMe has historically taken an active role in communicating with the FDA about our service and the last eight months have been no exception. We believe that individuals have a right to access their genetic information and to understand what they are getting.

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23andMe to Attend FDA Public Advisory Committee Meeting on Direct-to-Consumer Genetic Tests