23 and me, the food and drug administration, and the future of genetic testing

JAMA Internal Medicine

Volumn 174, Issue 4, 2014, Pages 493-494

  Zettler, Patricia J ^a   Sherkow, Jacob S ^a   Greely, Henry T ^b  

^a STANFORD LAW SCHOOL   (United States)

^b STANFORD UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALLELE; BREAST CANCER; CYSTIC FIBROSIS; DNA SEQUENCE; FOOD AND DRUG ADMINISTRATION; GENETIC SCREENING; GENETIC VARIABILITY; HIGH THROUGHPUT SEQUENCING; HUMAN; MEDICAL INFORMATION; NOTE; PRIORITY JOURNAL; PROTEIN SYNTHESIS; RISK ASSESSMENT; SINGLE NUCLEOTIDE POLYMORPHISM; ARTICLE; DIAGNOSTIC TEST APPROVAL; LEGAL ASPECT; MARKETING; UNITED STATES;

DIAGNOSTIC TEST APPROVAL; GENETIC TESTING; HUMANS; MARKETING; POLYMORPHISM, SINGLE NUCLEOTIDE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84898404100     PISSN: 21686106     EISSN: None     Source Type: Journal    
DOI: 10.1001/jamainternmed.2013.14706     Document Type: Note

References (8)

1. US Food and Drug Administration.Warning letter of November 22, 2013. www.fda.gov/ICECI /EnforcementActions/WarningLetters/2013 /ucm376296.htm. Accessed December 13, 2013.
2. Federal Food, Drug, and Cosmetic Act, section 201(h) (21 U.S.C. 321(h)).
3. Kutz G. Testimony on direct-to-consumer genetic tests: misleading test results are further complicated by deceptive marketing and other questionable practices. http://www.gao.gov/new.items/d10847t.pdf. Accessed January 3, 2014.
4. Ng PC, Murray SS, Levy S, Venter JC. An agenda for personalized medicine. Nature. 2009;461(7265):724-726.
5. Mihaescu R, van Hoek M, Sijbrands EJ, et al. Evaluation of risk prediction updates from commercial genome-wide scans. Genet Med. 2009;11(8):588-594.
6. 23andMe. 23andMe statement regarding FDA warning letter, November 25, 2013. blog.23andme.com/news/23andme-statement-regarding-fda -warning-letter/. Accessed December 13, 2013.
7. 23andMe. 23andMe provides an update regarding FDA's review, December 5, 2013. blog.23andme.com /news/23andme-provides-an-update-regarding -fdas-review/. Accessed December 13, 2013.
8. Collins FS, HamburgMA. First FDA authorization for next-generation sequencer. N Engl J Med. 2013;369(25):2369-2371. doi:10.1056 /NEJMp1314561.