Test type
Ancestry tests: what FDA reviews
For people who want to know: where my ancestors came from.
What FDA says
Not reviewed by FDA
FDA has no list of ancestry tests to check against. An ancestry kit still collects your DNA, so the privacy questions apply just the same.
FDA's page:
Some tests are used to help individuals explore their genetic ancestry. The FDA does not review these types of tests.
FDA records for this type: none. There is nothing to match a product against.
What every home DNA result has in common
FDA: “No test is 100% accurate.” (U.S. Food and Drug Administration) MedlinePlus adds that “additional testing through a healthcare provider is usually required before direct-to-consumer test results can be used to diagnose a medical condition or make healthcare decisions.” (MedlinePlus)
Other test types
- Carrier screening: exempt from premarket notification, with conditions (FDA's wording and conditions are on that page)
- Genetic health risk: first test reviewed; later tests exempt, with conditions (FDA's wording and conditions are on that page)
- Cancer predisposition: FDA reviews before sale (FDA's wording and conditions are on that page)
- Pharmacogenetics: FDA reviews before sale (FDA's wording and conditions are on that page)
- Wellness and traits: generally not reviewed by FDA (FDA's wording and conditions are on that page)