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Direct-to-consumer personal genomic tests need better regulation

Nature Medicine volume 27, pages 940–943 (2021)Cite this article

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Increasingly, data are collected by companies that provide direct-to-consumer personal genomic tests, yet the existing health legislation covering the use of these data is lagging far behind in the USA.

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Fig. 1: A brief history of diagnostic test regulation for DTC PGT.
Fig. 2: The market landscape for DTC PGT companies in 2020.

References

  1. Ross, C. & Herper, M. STAT https://www.statnews.com/2021/02/04/23andme-richard-branson-spac-ipo/ (4 February 2021).

  2. Brodwin, E. STAT https://www.statnews.com/2020/08/05/blackstone-ancestry-dna-acquisition/ (5 August 2020).

  3. Cameron, T. & Morrison, C. Nat. Rev. Drug Discov. 20, 93–94 (2021).

    Article  CAS  Google Scholar 

  4. Eissenberg, J. C. Mo. Med. 114, 26–32 (2017).

    PubMed  PubMed Central  Google Scholar 

  5. GSK. https://www.gsk.com/en-gb/media/press-releases/gsk-and-23andme-sign-agreement-to-leverage-genetic-insights-for-the-development-of-novel-medicines/ (25 July 2018).

  6. Regalado, A. MIT Technology Review https://www.technologyreview.com/2019/02/11/103446/more-than-26-million-people-have-taken-an-at-home-ancestry-test/ (11 February 2019).

  7. Owermohle, S. POLITICO https://politi.co/2YQgXSy (5 February 2021).

  8. Janssens, A.C.J.W. in Clinical Genome Sequencing (eds. Tibben, A. & Biesecker, B.B.) 89–101 (Academic Press, 2019).

  9. Downing, N. S. & Ross, J. S. J. Am. Med. Assoc. 311, 793–794 (2014).

    Article  CAS  Google Scholar 

  10. Office for Civil Rights. HHS https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html (7 May 2008).

  11. The European Parliament and the Council of the European Union. EUR-Lex http://data.europa.eu/eli/reg/2016/679/oj/eng (27 April 2016).

  12. 23andMe. https://mediacenter.23andme.com/press-releases/23andme-signs-a-strategic-agreement-with-almirall (13 January 2020).

  13. 23andMe. 23andMeBlog https://blog.23andme.com/news/23andme-and-gsk-clinical-trial/ (29 July 2020).

  14. Muoio, D. MobiHealthNews https://www.mobihealthnews.com/news/ancestrys-new-510k-clearances-point-toward-otc-consumer-genetic-health-risk-testing (24 August 2020).

  15. 23andMe. 23andMeBlog https://blog.23andme.com/news/pharmacogenetics-report/ (18 August 2020).

  16. Hazel, J. & Slobogin, C. Cornell Journal of Law and Public Policy, 2018, Vanderbilt Law Research Paper No. 18-18. available at SSRN https://papers.ssrn.com/abstract=3165765 (accessed 30 October 2020).

  17. 23andMe. https://www.23andme.com/about/privacy/ (accessed 30 October 2020).

  18. Tanner, A. UNDARK https://perma.cc/4DQZ-G9HR (13 September 2016).

  19. Loria, K. Consumer Reports https://www.consumerreports.org/health-privacy/how-to-delete-genetic-data-from-23andme-ancrestry-other-sites/ (29 January 2019).

  20. Rothstein, M. A. Gene Watch 22, 9–12 (2009).

    Google Scholar 

  21. Na, L. et al. JAMA Netw. Open 1, e186040 (2018).

    Article  Google Scholar 

  22. Yaraghi, N. Brookings https://www.brookings.edu/blog/techtank/2018/11/19/who-should-profit-from-the-sale-of-patient-data/ (19 November 2018).

  23. Hall, M.A. Iowa Law Review http://www.uapd.com/wp-content/uploads/Property-Privacy-and-the-Pursuit-of-Interconnected-EMR.pdf (29 January 2009).

  24. LunaPBC. https://www.lunadna.com/ownership-shares-for-sharing-data-2/ (5 December 2018).

  25. US Senate. Congress.gov https://www.congress.gov/bill/117th-congress/senate-bill/500/text (3 January 2021).

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Author information

Authors and Affiliations

  1. Yale School of Medicine, New Haven, CT, USA

    Osman Moneer

  2. Section of General Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT, USA

    Jennifer E. Miller & Joseph S. Ross

  3. Division of Health Care Delivery Research, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA

    Nilay D. Shah

  4. Yale National Clinician Scholars Program, Yale School of Medicine, New Haven, CT, USA

    Joseph S. Ross

  5. Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA

    Joseph S. Ross

  6. Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA

    Joseph S. Ross

Authors
  1. Osman Moneer
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  2. Jennifer E. Miller
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  3. Nilay D. Shah
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  4. Joseph S. Ross
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Contributions

O.M., J.E.M. and J.S.R. conceptualized the manuscript, OM drafted the manuscript, JSR provided supervision, and all authors critically revised the manuscript for important intellectual content.

Corresponding author

Correspondence to Joseph S. Ross.

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Competing interests

J.E.M. and J.S.R. receive research support through Yale University from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International. N.D.S. has received research support through Mayo Clinic from the Food and Drug Administration to establish the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938); the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative; the Agency for Healthcare Research and Quality (R01HS025164, R01HS025402, R03HS025517 and K12HS026379); the National Heart, Lung and Blood Institute of the US National Institutes of Health (R56HL130496, R01HL131535 and R01HL151662); the National Science Foundation; and the Patient Centered Outcomes Research Institute to develop a Clinical Data Research Network (LHSNet). J.S.R. has received research support through Yale University from the Laura and John Arnold Foundation for the Collaboration for Research Integrity and Transparency at Yale; and receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale–Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938); from the Agency for Healthcare Research and Quality (R01HS022882), and from the National Heart, Lung and Blood Institute of the US National Institutes of Health (R01HS025164 and R01HL144644).

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Moneer, O., Miller, J.E., Shah, N.D. et al. Direct-to-consumer personal genomic tests need better regulation. Nat Med 27, 940–943 (2021). https://doi.org/10.1038/s41591-021-01368-9

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