Bridging the Consumer-Medical Divide: How to Regulate Direct-to-Consumer Genetic Testing

Hastings Center Report

Volumn 44, Issue 3, 2014, Pages 17-19

  Edwards, Kyle T ^a   Huang, Caroline J ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADVERTIZING; ARTICLE; CONSUMER; ETHICS; FOOD AND DRUG ADMINISTRATION; GENETIC DISORDER; GENETIC SCREENING; GENETICS; HEALTH CARE COST; HUMAN; LABORATORY DIAGNOSIS; LEGAL ASPECT; METHODOLOGY; PREGNANCY TEST; PSYCHOLOGICAL ASPECT; STANDARD; UNITED STATES;

ADVERTISING AS TOPIC; CONSUMER SATISFACTION; FALSE POSITIVE REACTIONS; GENETIC DISEASES, INBORN; GENETIC TESTING; HEALTH CARE SECTOR; HUMANS; PREGNANCY TESTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84900035757     PISSN: 00930334     EISSN: 1552146X     Source Type: Journal    
DOI: 10.1002/hast.310     Document Type: Article

References (9)

1. 23andMe, "About Us, " accessed February 4, 2014, at https://www.23andme.com/about/.
2. U.S. Food and Drug Administration, Center for Devices and Radiological Health, "23andMe, Inc. Warning Letter, " GEN1300666, November 22, 2013, at http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm.
3. 23andMe, "Changes to Our Health-Related Products, " accessed February 4, 2014, at https://www.23andme.com/health/.
4. Larry Downes and Paul Nunes, "Regulating 23andMe to Death Won't Stop the New Age of Genetic Testing, " Wired, January 1, 2014, http://www.wired.com/opinion/2014/01/the-fda-may-win-the-battle-this-holiday-season-but-23andme-will-win-the-war/.
5. U.S. Food and Drug Administration, "Warning Letter" to 23andMe, Inc., November 22, 2013, accessed April 22, 2014, http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm.
6. Anne Wojcicki, "23andMe Provides an Update regarding FDA's Review, " 23andMe (blog), December 5, 2013, accessed February 4, 2014, at http://blog.23andme.com/news/23andme-provides-an-update-regarding-fdas-review/.
7. Roger Collier, "Genetic Literacy Poor in Primary Care, " Canadian Medical Association Journal 184, no. 9 (2012): E467-E468, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3381765/.
8. U.S. Department of Health and Human Services, Office on Women's Health, "Knowing If You Are Pregnant, " last updated September 27, 2010, http://www.womenshealth.gov/pregnancy/before-you-get-pregnant/knowing-if-pregnant.html.
9. U.K. Department of Health, Human Genetics Commission, "A Common Framework of Principles for Direct-to-Consumer Genetic Testing Services, " 2010, http://www.webarchive.org.uk/wayback/archive/20101209080838/http://www.bshg.org.uk/Principles.pdf.