Direct-to-consumer genetics – a new era in personalized medicine?

10 May 2017

Direct-to-consumer (DTC) genetics company 23andMe was recently granted approval by the Food and Drug Administration to market their tests providing information on gene variants for certain debilitating diseases, says Dr Nicola Davies in her monthly FDA blog for The Pharma Letter.

These diseases include Parkinson’s and celiac disease. However, 23andMe has a history of dealings with the FDA, including bans and warning letters relating to its practices and products. With this in mind, what steps do DTC genetics companies need to follow in order to meet FDA approval, and how have the FDA’s regulations evolved over the years in relation to this relatively new field of medical services?

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