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.
