FDA Grants Marketing Authorization for Personal Genetic Risk Tests

The U.S. Food and Drug Administration (FDA) has approved marketing for 23andMe Personal Genome Service Genetic Health Risk (GHR) tests, the first direct-to-consumer tests that analyze DNA from users’ saliva samples to calculate their genetic predisposal for the following 10 diseases and conditions:

  • Parkinson’s disease
  • late-onset Alzheimer’s disease
  • celiac disease
  • alpha-1 antitrypsin deficiency
  • early-onset primary dystonia
  • factor XI deficiency
  • Gaucher disease type 1
  • glucose-6-Phosphate Dehydrogenase deficiency
  • hereditary hemochromatosis
  • hereditary thrombophilia

The FDA’s decision was supported by an analysis of peer-reviewed literature establishing a strong link between genetic variants and the 10 conditions included on the test. Data were reviewed through the FDA’s device premarket review pathway, which regulates low- to moderate-risk devices while simultaneously establishing criteria (“special controls”) to ensure accuracy, reliability, and clinical relevance in the testing.

The FDA cautioned that results from testing should still be monitored by a health-care professional because of the risk associated with the test, including false-positive and false-negative findings.

Source: U.S. FDA press release, April 6, 2017.