U.S. Food and Drug Administration approved 23andMe’s genetic test for consumers, enabling detection of person’s risk to 10 diseases

Briefing

U.S. Food and Drug Administration approved 23andMe’s genetic test for consumers, enabling detection of person’s risk to 10 diseases

April 17, 2017

Briefing
  • Approved Consumer Genetic Test – U.S. Food and Drug Administration (FDA) allowed 23andMe to market their genetic tests direct to consumer
  • Identifies 10 Diseases – Identifies person’s genetic risk to 10 diseases, including Parkinson’s, Alzheimer’s, and celiac disease
  • How It Works – Company analyzes genetic information from saliva sample and tests it among more than 500,000 genetic variants, with results available online
  • Disclaimer – Results do not mean people will actually develop disease, as there are other factors to consider, such as environment and lifestyle
  • Applications – Can inform lifestyle choices and discussions with heath care professionals
  • 2013 FDA Ban – FDA banned sale of genetic tests in November 2013, with agency concerned that results could mislead consumers into availing unnecessary treatments

Accelerator
Biotechnology and Bioinformatics, Fitness, Wellness and Healthcare Delivery

Sector
Healthcare/Health Sciences

Organization
23andMe Inc., U.S. Food and Drug Administration

Source

Original Publication Date
April 6, 2017

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