Regulatory compliance in the direct-to-consumer genetic testing market is highly sophisticated as there are numerous federal, state, and ethical barriers to entry. In 2010, amid an underregulated market, 23andMe sought to do what few companies in the medical industry had attempted before—disregard the guidance and requests of the US Food and Drug Administration. This regulatory strategy effectively destined the company’s Personal Genome Service for failure; however, the company changed course and has been granted several regulatory clearances. This exemplifies the importance of a healthy relationship with regulatory agencies, although challenges remain. The DTC industry continues to have a perplexing regulatory framework at both the federal and state level. There are also ethical concerns with the monetization of deidentified genetic health information, as genetic data have an inherent level of identifiability and are not fully protected by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in these scenarios. Although some DTC tests are now cleared in the United States, the concern that a learned intermediary is needed for interpretation of results remains. The regulatory oversight of this market will need to continue to develop to ensure the protection of consumer health and privacy.
KutzG.Direct-to-consumer genetic tests: misleading test results are further complicated by deceptive marketing and other questionable practices: congressional testimony. Washington, DC: United States Government Accountability Office; 2010.
RobertsMCDusetzinaSB. The effect of a celebrity health disclosure on demand for health care: trends in BRCA testing and subsequent health services use. J Commun Genet. 2017;8:141–146.
5.
DesaiSJenaAB. Christmas 2016: Famous Figures: Do celebrity endorsements matter? Observational study of BRCA gene testing and mastectomy rates after Angelina Jolie’s New York Times editorial. BMJ. 2016;355.
6.
GutierrezA. Untitled Letter to Anne Wojcicki, C.E.O., 23andMe, Inc. Silver Springs, MD: Food and Drug Administration (FDA), HHS; 2013.
7.
Centers for Medicare & Medicaid Services (CMS). Clinical Laboratory Improvement Amendments (CLIA). Baltimore, MD: CMS, US Department of Health and Human Services (HHS); 2005.
8.
PollackA. FDA faults companies on unapproved genetic tests. The New York Times, 611, 2010: 12, B2.
FDA. Discussion paper on laboratory developed tests (LDTs). Silver Spring, MD: FDA, HHS; 2017.
21.
NorrgardK. DTC genetic testing for diabetes, breast cancer, heart disease and paternity. Nature Educ2008:1(1).
22.
FDA. Framework for Regulatory Oversight of Laboratory Developed Tests; Draft Guidance for Industry. Silver Spring MD: FDA, HHS; 2014.
23.
CMS. CLIA program and HIPAA privacy rule; patients’ access to test reports. Final rule. Fed Regist. 2014;79(25):7289.
24.
SchlangerSJ. Filling in the cracks: improving the regulation of direct-to-consumer genetic tests. J Health Care Law Policy; 2011:Appendix S,14, 1.
25.
DickHC. Risk and responsibility: state regulation and enforcement of the direct-to-consumer genetic testing industry. Louis UJ Health Law Policy. 2012:6:167.
FTC. Docket no. C-4456, in the matter of GeneLink, Inc., decision and order, May 8, 2014. Washington DC: FTC; 2014.
30.
FTC. Complaint in the matter of L’Oreal USA Inc. Washington, DC: FTC; 2014.
31.
EEOC v. Fabricut, 13-CV-248-CVE-PJC (US District Court for the Northern District of Oklahoma, May 7, 2013).
32.
HHS. Modifications to the HIPAA privacy, security, enforcement, and breach notification rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; other modifications to the HIPAA Rules. Fed Regist. 2013:78:5566–5702.
33.
CMS. The Health Insurance Portability and Accountability Act of 1996 (HIPAA). Baltimore, MD: CMS, HHS; 1996.
34.
HHS. Guidance regarding methods for de-identification of protected health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. Baltimore, MD: HHS; 2015.
HeeneyCHawkinsNDe VriesJBoddingtonPKayeJ. Assessing the privacy risks of data sharing in genomics. Public Health Genom. 2011;14:17–25.
38.
SchadtEEWooSHaoK. Bayesian method to predict individual SNP genotypes from gene expression data. Nature Genet. 2012;44:603–608.
39.
GymrekMMcGuireALGolanDHalperinEErlichY. Identifying personal genomes by surname inference. Science. 2013;339;321–324.
40.
HerperM. Surprise! with $60 million Genentech deal, 23andMe has a business plan. Forbes. 2015.
41.
NorrgardK. DTC genetic testing for diabetes, breast cancer, heart disease and paternity. Nat Educ. 2008;1.
42.
CaulfieldTBorryPToewsMElgerBSGreelyHTMcGuireA. Marginally scientific? Genetic testing of children and adolescents for lifestyle and health promotion. Journal of Law and the Biosciences. 2015;2:627.
43.
ClaytonEWMcCulloughLBBieseckerLG, et al. Addressing the ethical challenges in genetic testing and sequencing of children. Am J Bioethics. 2014;14;3–9.
RobertsJSOstergrenJ. Direct-to-consumer genetic testing and personal genomics services: a review of recent empirical studies. Curr Genet Med Rep. 2013;1:182–200.
47.
Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (N.J. 1999).
