23andMe paves the way for direct-to-consumer genetic health risk tests of limited clinical utility

Annals of Internal Medicine

Volumn 167, Issue 2, 2017, Pages 125-126

  Wynn, Julia ^a   Chung, Wendy K ^a  

^a Department of Medicine   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA 1 ANTITRYPSIN DEFICIENCY; ALZHEIMER DISEASE; BLOOD CLOTTING FACTOR 11 DEFICIENCY; CELIAC DISEASE; DYSTONIA; FALSE NEGATIVE RESULT; FAMILY HISTORY; FOOD AND DRUG ADMINISTRATION; GAUCHER DISEASE; GENETIC RISK; GENETIC SCREENING; GENETIC VARIABILITY; GENOTYPE; GLUCOSE 6 PHOSPHATE DEHYDROGENASE DEFICIENCY; HEMOCHROMATOSIS; HUMAN; MEDICAL LITERATURE; NOTE; PARKINSON DISEASE; PREDICTIVE VALUE; PRIORITY JOURNAL; THROMBOPHILIA; GENETIC PREDISPOSITION; MARKETING; SCREENING TEST; UNITED STATES;

DIRECT-TO-CONSUMER SCREENING AND TESTING; GENETIC PREDISPOSITION TO DISEASE; GENETIC TESTING; GENOTYPE; HUMANS; MARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85025097992     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/M17-1045     Document Type: Note

References (6)

1. FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions [press release]. Silver Spring: U.S. Food and Drug Administration; 6 April 2017. Accessed at www.fda.gov/newsevents/newsroom/pressannouncements/ucm551185.htm on 12 May 2017.
2. Gutierrez A; U.S. Food and Drug Administration. Warning letter to 23andMe (Ann Wojcicki) on Personal Genome Service. 22 November 2013. Document no. GEN1300666. Accessed at www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm on 12 May 2017.
3. 23andMe. Good news about health reports. 6 April 2017. Accessed at https://medical.23andme.org/health-reports on 12 May 2017.
4. Wynn J, Martinez J, Duong J, Chiuzan C, Phelan JC, Fyer A, et al. Research participants' preferences for hypothetical secondary results from genomic research. J Genet Couns. 2016. [PMID: 28035592] doi:10.1007/s10897-016-0059-2
5. ACMG Board of Directors. Direct-to-consumer genetic testing: a revised position statement of the American College of Medical Genetics and Genomics. Genet Med. 2016;18:207-8. [PMID: 26681314] doi:10.1038/gim.2015.190
6. NSGC releases statement calling for consumer protection in the absence of federal safeguards for DTC genetic tests [press release]. Chicago: National Society of Genetic Counselors; 27 July 2010. Accessed at www.nsgc.org/p/bl/et/blogaid=8 on 12 May 2017.