1 |
iSpot.tv. 23 and Me (TV commercial). Bellevue: iSpot.tv, 2013. Accessed 2014 Nov 1. Available from: http://www.ispot.tv/ad/7qoF/23-and-me.
|
2 |
Wojcicki A. Just the facts, please. Nat Biotechnol 2013;31:1075-1076.
DOI
|
3 |
Hogarth S, Javitt G, Melzer D. The current landscape for direct- to-consumer genetic testing: legal, ethical, and policy issues. Annu Rev Genomics Hum Genet 2008;9:161-182.
DOI
ScienceOn
|
4 |
Hindorff LA, Sethupathy P, Junkins HA, Ramos EM, Mehta JP, Collins FS, et al. Potential etiologic and functional implications of genome-wide association loci for human diseases and traits. Proc Natl Acad Sci U S A 2009;106:9362-9367.
DOI
ScienceOn
|
5 |
American College of Medicine Genetics Board of Directors. ACMG statement on direct-to-consumer genetic testing. Genet Med 2004;6:60.
|
6 |
Hudson K, Javitt G, Burke W, Byers P; American Society of Human Genetics Social Issues Committee. ASHG Statement* on direct-to-consumer genetic testing in the United States. Obstet Gynecol 2007;110:1392-1395.
DOI
|
7 |
US Centers for Disease Control and Prevention. Genomic testing: ACCE model process for evaluating genetic tests. Atlanta: US Centers for Disease Control and Prevention, 2010. Accessed 2014 Nov 1. Available from: http://www.cdc.gov/genomics/gtesting/ACCE/.
|
8 |
23andMe. FDA update: December 5th. Palo Alto: 23andMe, 2013. Accessed 2014 Nov 1. Available from: https://customercare.23andme.com/entries/23273619-FDAUpdate-December-23273615th.
|
9 |
US Food and Drug Administration. Close out letter, March 25, 2014. Silver Spring: US Food and Drug Administration, 2014. Accessed 2014 Nov 1. Available from: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm391016.htm.
|
10 |
O'Connor L. 23andMe faces $5 million lawsuit days after being banned by FDA. The Huffington Post, 2013. Accessed 2014 Nov 1. Available from: http://www.huffingtonpost.com/2013/2012/2004/2023andme-lawsuit_n_4387699.html.
|
11 |
CBS News. 23andMe personalized DNA test seeks FDA approval. New York: CBS Interactive Inc., 2012. Accessed 2014 Nov 1. Available from: http://www.cbsnews.com/news/23andme-personalized-dna-test-seeks-fda-approval/.
|
12 |
CBC News. 23andMe genetic testing service raises ethical questions. New York: CBS Interactive Inc., 2014. Accessed 2014 Nov 1. Available from: http://www.cbc.ca/news/business/23andme-genetic-testing-service-raises-ethical-questions-1.2785522.
|
13 |
Downing NS, Ross JS. Innovation, risk, and patient empowerment: the FDA-mandated withdrawal of 23andMe's Personal Genome Service. JAMA 2014;311:793-794.
DOI
|
14 |
Zettler PJ, Sherkow JS, Greely HT. 23andMe, the Food and Drug Administration, and the future of genetic testing. JAMA Intern Med 2014;174:493-494.
DOI
|
15 |
Su P. Direct-to-consumer genetic testing: a comprehensive view. Yale J Biol Med 2013;86:359-365.
|
16 |
The FDA and me. Nature 2013;504:7-8.
|
17 |
Green RC, Farahany NA. Regulation: the FDA is overcautious on consumer genomics. Nature 2014;505:286-287.
DOI
|
18 |
Lee KL, Lee SM. Market Analysis and Strategies for Regulatory Reform in Medical Industry. Public-Private Joint Regulation Advancement Initiative, 2014.
|
19 |
TechFreedom. FDA: Don't ban marketing of home genomics kits like 23andMe. Change.org, 2014. Accessed 2014 Nov 1. Available from: https://www.change.org/petitions/fda-dont-ban-marketing-of-home-genomics-kits-like-23andme.
|
20 |
US Food and Drug Administration. Warning letter, Nov 22, 2013. Silver Spring: US Food and Drug Administration, 2013. Accessed 2014 Oct 31. Available from: http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm.
|
21 |
US Food and Drug Administration. FDA allows marketing of four "next generation" gene sequencing devices. Silver Spring: US Food and Drug Administration, 2013. Accessed 2014 Nov 1. Available from: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm375742.htm.
|