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23andME genetic testing
Clinical significance:
- direct to consumer genetic testing* provides information on genetic predisposition to:
- late-onset Alzheimer's disease
- Parkinson's disease
- celiac disease
- alpha1-antitrypsin deficiency
- early-onset primary dystonia
- factor XI deficiency
- Gaucher disease type 1
- glucose-6-phosphate dehydrogenase deficiency
- hereditary hemochromatosis
- hereditary thrombophilia
* FDA-approval April 2017
Notes:
- 23andME 1st direct to consumer genetic test FDA-approved in February 2015 identified a person's carrier status for Bloom syndrome
- 23andME has also received FDA approval for direct to consumer marketing of genetic tests for risk factors for
- cystic fibrosis
- sickle cell anemia
- Tay-Sachs disease [1]
- breast cancer [2]
- reports 3 of > 1000 known BRCA mutations [2]
- FDA-approved testing for genetic variants that may affect ability to metabolize certain drugs
General
direct-to-consumer laboratory testing
DNA (genetic) testing
References
- Lowes T
FDA OKs First Direct-to-Consumer Genetic Risk Tests
Medscape. Apr 06, 2017.
http://www.medscape.com/viewarticle/878287
- FDA News Release. April 6, 2017
FDA allows marketing of first direct-to-consumer tests that
provide genetic risk information for certain conditions.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551185.htm
- FDA News Release. March 6, 2018
FDA authorizes, with special controls, direct-to-consumer test
that reports three mutations in the BRCA breast cancer genes.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599560.htm
- FDA News Release. Oct 23, 2018
FDA authorizes first direct-to-consumer test for detecting genetic
variants that may be associated with medication metabolism.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624753.htm