23andME genetic testing
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Clinical significance
- direct to consumer genetic testing* provides information on genetic predisposition to:
* 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
More general terms
References
- ↑ 1.0 1.1 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 - ↑ 2.0 2.1 2.2 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