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The Future of DTC Genomics and the Law

Published online by Cambridge University Press:  01 January 2021

Henry T. Greely
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Abstract

Direct-to-Consumer (“DTC”) genomics has been a controversial topic for over a decade. Much work has been done on the legal issues it raises. This article asks a different question: What will DTC genomics and its legal issues look like in ten to twenty years? After discussing the five current uses of DTC genomics, it describes three current legal issues: medical uses, privacy of genomic information, and privacy in collection and analysis of human DNA. It then suggests that changes in human genomics and how it is used will make the first of those DTC genomics legal issues less important in the future, but that the third will be increasingly significant.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 48 , Issue 1: LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application , Spring 2020 , pp. 151 - 160
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

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References

Wolf, S. M. et al., “Integrating Rules for Genomic Research, Clinical Care, Public Health Screening & DTC Testing: Creating Translational Law for Translational Genomics,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 69–86.Google Scholar
See also Cohen, I.G., Farahany, N.A., and Greely, H.T., eds., Consuming Genomics: Ethical and Legal Considerations of New Technologies (Cambridge, England: Cambridge University Press, forthcoming 2020) (an edited volume with about 15 chapters, drawn from the May 2019 conference of the same name).Google Scholar
23andMe, About Us, 23andMe.com, available at <https://mediacenter.23andme.com/company/about-us/> (last visited September 28, 2019).+(last+visited+September+28,+2019).>Google Scholar
“Life Technologies Acquires Consume Genetics Testing Firm Navigenics,” GenomeWeb, July 17, 2012, available at <https://www.genomeweb.com/diagnostics/life-technologies-acquires-consumer-genetics-testing-firm-navigenics#.XY03FZNKjOY> (last visited September 28, 2019). Vorhaus, D., “Implications of Amgen/deCODE Deal for Genetic Testing Consumes,” The Privacy Report, December 10, 2012, available at <https://theprivacyreport.com/2012/12/10/implications-of-amgendecode-deal-for-genetic-testing-consumers/> (last visited Sept. 28, 2019). For more details about the history of development of medical DTC testing, see Greely, H.T., “Ethical Issues in Clinical Genetics and Genomic, in Genomic Applications in Pathology,” edited by Netto, G.J. and Kaul, K.L., 2d ed. (New York: Springer, 2019).+(last+visited+September+28,+2019).+Vorhaus,+D.,+“Implications+of+Amgen/deCODE+Deal+for+Genetic+Testing+Consumes,”+The+Privacy+Report,+December+10,+2012,+available+at++(last+visited+Sept.+28,+2019).+For+more+details+about+the+history+of+development+of+medical+DTC+testing,+see+Greely,+H.T.,+“Ethical+Issues+in+Clinical+Genetics+and+Genomic,+in+Genomic+Applications+in+Pathology,”+edited+by+Netto,+G.J.+and+Kaul,+K.L.,+2d+ed.+(New+York:+Springer,+2019).>Google Scholar
Regalado, A., “More Than 26 Million People Have Taken An At-Home Ancestry Test,” MIT Technology Review, February 11, 2019, available at <https://www.technologyreview.com/s/612880/more-than-26-million-people-have-taken-anat-home-ancestry-test/> (last visited September 26, 2019). (These are not just U.S. customers; those numbers do not seem to be available.) Ironically this article states that the number could be 100 million within 24 months if the growth seen in 2018 continues. As discussed below, it did not. In October 2019, Ancestry announced that it would begin offering some DNA-related health information to users, supervised by a physician although not the customer's primary care physician.+(last+visited+September+26,+2019).+(These+are+not+just+U.S.+customers;+those+numbers+do+not+seem+to+be+available.)+Ironically+this+article+states+that+the+number+could+be+100+million+within+24+months+if+the+growth+seen+in+2018+continues.+As+discussed+below,+it+did+not.+In+October+2019,+Ancestry+announced+that+it+would+begin+offering+some+DNA-related+health+information+to+users,+supervised+by+a+physician+although+not+the+customer's+primary+care+physician.>Google Scholar
Imbeault, R., “A DNA Test Revealed A Sister I Never Knew Existed. Now What?” The Globe and Mail, September 17, 2019 (the author expresses a “miscellany of emotions,” including confusion, anger, excitement, joy, and skepticism upon learning he had a sister); Shapiro, D., Inheritance: A Memoir of Genealogy, Paternity, and Love (New York: Alfred A. Knopf, 2019), (mixed reaction to misattributed paternity revelation); Hertz, R. and Nelson, M. K., Random Families: Genetic Strangers, Sperm Donor Siblings, and the Creation of New Kin (New York: Oxford University Press, 2018); Baden-Lasar, E., “A Family Portrait: Brothers, Sisters, Strangers,” New York Times Magazine, available at <https://www.nytimes.com/interactive/2019/06/26/magazine/sperm-donor-siblings.html> (last visited October 7, 2019).Google Scholar
Moray, N. et al., “Paternity Testing Under the Cloak of Recreational Genetics,” European Journal of Human Genetics 25, no. 6 (2017): 768–770. For a larger discussion on the ethics of paternity testing generally, see Trent, R.J., “Ethical, Legal, and Social Issues,” in Molecular Medicine, Genomics to Personalized Healthcare (Elsevier, 2019): 301–328, 322.Google Scholar
DNA Solutions, “Secret Paternity Test,” available at <https://www.dnanow.com/secret-dna-test.htm> (last visited October 7, 2019).+(last+visited+October+7,+2019).>Google Scholar
“23andMe, Our Services,” 23andMe.com, available at <https://www.23andme.com/dna-reports-list/> (last visited September 27, 2019).+(last+visited+September+27,+2019).>Google Scholar
Alberto Gutierrez to Ann Wojcicki, Warning Letter, November 22, 2013, available at <https://wayback.archive-it.org/7993/20170722040905/ https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm> (last visited September 28, 2019); Pollack, A., “F.D.A. Orders Genetic Testing Firm to Stop Selling DNA Analysis Service,” The New York Times, November 25, 2013, available at <https://www.nytimes.com/2013/11/26/business/fda-demands-a-halt-to-a-dna-test-kits-marketing.html> (last visited October 8, 2019).+(last+visited+September+28,+2019);+Pollack,+A.,+“F.D.A.+Orders+Genetic+Testing+Firm+to+Stop+Selling+DNA+Analysis+Service,”+The+New+York+Times,+November+25,+2013,+available+at++(last+visited+October+8,+2019).>Google Scholar
U.S. Food and Drug Administration, Lists of Direct-to-Consumer Tests with Marketing Authorization, available at <https://www.fda.gov/medical-devices/vitro-diagnostics/direct-consumer-tests> (last visited September 26, 2019).+(last+visited+September+26,+2019).>Google Scholar
This is not quite technically accurate. Clinical human geneticists can also order genetic tests and receive results from traditional laboratories, but they can be people with Ph.D.s in genetics and not M.D.s, and hence not “physicians.” But they are few in number — about 1,600 in the United States (some of whom will also have M.D. degrees and be licensed physicians). Compare Regier, D. S. et al., “Medical Genetics and Genomic Medicine in the United States. Part 2: Reproductive Genetics, Newborn Screening, Genetic Counseling, Training, and Registries,” Molecular Genetics & Genomic Medicine 5, no. 6 (2017): 621–630, 625 (noting, as of 2015, there are about 1600 clinical geneticists) with Young, A. et al., “A Census of Actively Licensed Physicians in the United States,” Journal of Medical Regulation 103, no. 2 (2017): 7–21, 7 (noting there are nearly 1 million active physicians).CrossRefGoogle Scholar
MyHeritage, “Health,” MyHeritage.com, available at <https://www.myheritage.com/health> (last visited September 28, 2019); See also Petrone, J., “MyHeritage Moves Into Health with New Genetic Testing Offering, Underscoring Industry Trend,” GenomeWeb, May 28, 2019, available at <https://www.genomeweb.com/applied-markets/myheritage-moves-health-new-genetic-testing-offering-underscoring-industry-trend> (last visited September 28, 2019).+(last+visited+September+28,+2019);+See+also+Petrone,+J.,+“MyHeritage+Moves+Into+Health+with+New+Genetic+Testing+Offering,+Underscoring+Industry+Trend,”+GenomeWeb,+May+28,+2019,+available+at++(last+visited+September+28,+2019).>Google Scholar
“Color, How it Works,” Color.com, available at <https://www.color.com/providers/how-it-works> (last visited September 27, 2019). Consumers cannot directly order genetic tests through Color. Instead, genetic testing must be ordered by a healthcare provider. Results are provided to both patient and healthcare provider, and genetic counselling is offered with each test. Healthcare providers can order testing on hereditary risk for high cholesterol, certain cancers, and responses to medication.+(last+visited+September+27,+2019).+Consumers+cannot+directly+order+genetic+tests+through+Color.+Instead,+genetic+testing+must+be+ordered+by+a+healthcare+provider.+Results+are+provided+to+both+patient+and+healthcare+provider,+and+genetic+counselling+is+offered+with+each+test.+Healthcare+providers+can+order+testing+on+hereditary+risk+for+high+cholesterol,+certain+cancers,+and+responses+to+medication.>Google Scholar
23andMe, supra note 9.Google Scholar
Robbins, R., “FDA Warns Testing Companies: Don't Tell Patients How Their DNA Influences Responses to Specific Drugs,” Stat+, August 28, 2019, available at <https://www.statnews.com/2019/08/28/fda-warns-pharmacogenetic-testing-companies/> (last visited September 26, 2019); Robbins, R., “Industry Groups Push Back Against ‘Troubling’ FDA Crackdown on Genetic Tests Used to Predict Response to Drugs,” Stat+, September 18, 2019, available at <https://www.statnews.com/2019/09/18/industry-groups-push-back-against-troubling-fda-crackdown-on-genetic-tests-used-to-predict-response-to-drugs/> (last visited September 26, 2019); “Mental Health Advocacy Groups Appeal to FDA to Reconsider PGx Enforcement Activity,” GenomeWeb, September 26, 2019, available at <https://www.genomeweb.com/molecular-diagnostics/mental-health-advocacy-groups-appeal-fda-reconsider-pgx-enforcement-activity?> (last visited September 26, 2019). (last visited September 26, 2019); Robbins, R., “Industry Groups Push Back Against ‘Troubling’ FDA Crackdown on Genetic Tests Used to Predict Response to Drugs,” Stat+, September 18, 2019, available at (last visited September 26, 2019); “Mental Health Advocacy Groups Appeal to FDA to Reconsider PGx Enforcement Activity,” GenomeWeb, September 26, 2019, available at (last visited September 26, 2019).' href=https://scholar.google.com/scholar?q=Robbins,+R.,+“FDA+Warns+Testing+Companies:+Don't+Tell+Patients+How+Their+DNA+Influences+Responses+to+Specific+Drugs,”+Stat+,+August+28,+2019,+available+at++(last+visited+September+26,+2019);+Robbins,+R.,+“Industry+Groups+Push+Back+Against+‘Troubling’+FDA+Crackdown+on+Genetic+Tests+Used+to+Predict+Response+to+Drugs,”+Stat+,+September+18,+2019,+available+at++(last+visited+September+26,+2019);+“Mental+Health+Advocacy+Groups+Appeal+to+FDA+to+Reconsider+PGx+Enforcement+Activity,”+GenomeWeb,+September+26,+2019,+available+at++(last+visited+September+26,+2019).>Google Scholar
“23andMe,” 23andMe.com, available at <https://www.23andme.com/dna-health-ancestry/#all-reports-list> (last visited September 27, 2019).+(last+visited+September+27,+2019).>Google Scholar
U.S. Food & Drug Administration, Direct to Consumer Tests, supra note 11; U.S. Food & Drug Administration, General Wellness: Policy for Low Risk Devices, General Guidance for Industry and Food and Drug Administration Staff (2019), available at <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices> (last visited September 28, 2019).+(last+visited+September+28,+2019).>Google Scholar
U.S. Food & Drug Administration, “General Wellness,” id.Google Scholar
Vorhaus, D., “DNA DTC: The Return of Direct to Consumer Whole Genome Sequencing,” The Privacy Report, November 29, 2012, available at <https://theprivacyreport.com/2012/11/29/dna-dtc-the-return-of-direct-to-consumer-whole-genome-sequencing/> (last visited September 28, 2019) (interesting discussion by of one such company and its likely reasons); Regalado, A., “How a Wiki Is Keeping Direct-to-Consumer Genetics Alive,” MIT Technology Review, October 19, 2014, available at <https://www.technologyreview.com/s/531461/how-a-wiki-is-keeping-direct-to-consumer-genetics-alive/> (last visited September 26, 2019).+(last+visited+September+28,+2019)+(interesting+discussion+by+of+one+such+company+and+its+likely+reasons);+Regalado,+A.,+“How+a+Wiki+Is+Keeping+Direct-to-Consumer+Genetics+Alive,”+MIT+Technology+Review,+October+19,+2014,+available+at++(last+visited+September+26,+2019).>Google Scholar
Nelson, S.C., “Consumer Genetic Testing Consumers Stretch Their DNA Data Further with Third-Party Interpretation Websites,” The Conversation, June 13, 2019, available at <https://theconversation.com/consumer-genetic-testing-customers-stretch-their-dna-data-further-with-third-party-interpretation-websites-118248> (last visited September 28, 2019); Moscarello, T. et al., “Direct-to-Consumer Raw Data and DNA Interpretation Services: More Burden Than Bargain?” Genetics in Medicine 21, no. 3 (2019): 539–541, 539; Promethease, available at <https://promethease.com/> (last visited September 28, 2019).Google Scholar
Interestingly, in September 2019, two of these services, Promethease and SNPedia.com, were acquired by the relatively new “quasi-DTC” firm, MyHeritage (which does require professional medical intermediation, at least in the United States, for its health products). Esther, “MyHeritage Acquires Promethease and SNPedia,” MyHeritage Blog, available at <https://blog.myheritage.com/2019/09/myheritage-acquires-promethease-and-snpedia/> (last visited September 26, 2019).+(last+visited+September+26,+2019).>Google Scholar
Marchant, G., “Liability Implications of Direct-to-Consumer Genetic Testing,” presentation at 2019 Petrie-Flom Center Annual Conference on Consumer Genetics: Ethical and Legal Considerations of New Technologies, Cambridge, MA, May 17, 2019, available at <https://vimeo.com/338077232> (last visited October 8, 2019).+(last+visited+October+8,+2019).>Google Scholar
Federal Food Drug and Cosmetic Act, 21 U.S.C. §§ 321, 360 et seq.; Medical Device Amendments of 1976, Pub. L. No. 94-295 (1976); Greely supra note 4; Evans, B.J. et al., “How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 44–68.CrossRefGoogle Scholar
Clinical laboratories are licensed by the states, accredited by the College of American Pathologists, and further regulated by a federal law, the Clinical Laboratory Improvement Amendments Act, implemented jointed by FDA, the Centers for Disease Prevention and Control, and the Centers for and Medicaid Services.Google Scholar
See U.S. Food & Drug Administration, Direct-to-Consumer Tests, supra note 11.Google Scholar
Green, R.C. and Farahany, N.A., “Regulation: The FDA Is Over Cautious on Consumer Genomics,” Nature 505, no. 7483 (2014): 286–287.Google Scholar
Zettler, P.J. et al., “23andMe, the Food and Drug Administration, and the Future of Genetic Testing,” JAMA Internal Medicine 174, no. 4 (2014): 493–494.CrossRefGoogle Scholar
Friedman, M., Capitalism and Freedom, Chap. 9 (Chicago, IL: Univ. Chicago Press: Chicago, 1962.) (attacking occupational licensure generally with a particular focus on medicine).Google Scholar
In Austria, France, Germany, Hungary, Italy, Lithuania, the Netherlands, Slovenia, Portugal, and Spain; genetic testing for health purposes can only be ordered under the supervision of a medical professional. See Kalokairinou, L. et al., “Legislation of Direct-To-Consumer Genetic Testing in Europe: A Fragmented Regulatory Landscape,” Journal of Community Genetics 9, no. 2 (2018): 117–132.CrossRefGoogle Scholar
Hazel, J.W., “Privacy Best Practices for Direct-to-Consumer Genetic Testing Services: Are Industry Efforts at Self-Regulation Sufficient?” in Consuming Genetics, supra note 2; Hazel, J. and Slobogin, C., “Who Knows What, And When?: A Survey of The Privacy Policies Proffered By U.S. Direct-To-Consumer Genetic Testing Companies,” Cornell Journal of Law and Public Policy 28, no. 1 (2018): 35–66.Google Scholar
Molteni, M., “What the Golden State Killer Tells Us About Forensic Genetics,” Wired, April 24, 2019, available at <https://www.wired.com/story/the-meteoric-rise-of-family-tree-forensics-to-fight-crimes/> (last visited Sept. 27, 2019). For the first substantial discussion of legal and scientific issues in family forensic DNA testing, see Greely, H.T. et al., “Family Ties: The Use of DNA Offender Databases to Catch Offenders’ Kin,” Journal of Law, Medicine & Ethics 34, no. 2 (2006): 248–262.Google Scholar
See, e.g., Roland, D., “How Drug Companies Are Using Your DNA To Make New Medicine,” The Wall Street Journal, July 22, 2019, available at <https://www.wsj.com/articles/23andmeglaxo-mine-dna-data-in-hunt-for-new-drugs-11563879881> (last visited September 2, 2019).+(last+visited+September+2,+2019).>Google Scholar
Kim, J. et al., “Patient Perspectives About Decisions to Share Medical Data and Biospecimens for Research,” JAMA Network Open, August 21, 2019, available at <doi: 10.1001/jamanetworkopen.2019.9550> (last visited February 9, 2020).CrossRef+(last+visited+February+9,+2020).>Google Scholar
Roberts, J. L., “Progressive Genetic Ownership,” Notre Dame Law Review 93, no. 3 (2018): 1105–1172, 1128.Google Scholar
Cole v. Gene by Gene, Ltd., No. 1:14-cv-00004, 2017 U.S. Dist. LEXIS 101761 at 7, *9 (D. Alaska June 30, 2017) (denying the defendant's motion to dismiss on the ground that Cole was able to demonstrate the requisite injury-in-fact under Alaska's Genetic Privacy Act, which “recognizes an exclusive property interest in one's DNA, and prohibits the unauthorized disclosure of DNA information”) See Roberts, supra note 35, at 1110 (describing the factual background underlying the Cole case. The Ninth Circuit has affirmed a denial of class certification in the Cole case. Cole v. Gene by Gene, Ltd., No. 17-35837 at 2 (9th Cir. August 21, 2018).Google Scholar
Greely, H.T., “Banning Genetic Discrimination,” New England Journal of Medicine 353: 865 (2005).Google Scholar
Joseph, A., “Health Tech Companies Are Swallowing Up Consumers’ DNA. Can Congress Safeguard What They Do With It?” Stat+, August 9, 2019, available at <https://www.stat-news.com/2019/08/09/health-tech-companies-consumer-dna-congress-safeguards/> (last viewed September 2, 2019).+(last+viewed+September+2,+2019).>Google Scholar
Sprenger, P., “Sun on Privacy: Get Over It,” Wired, January 26, 1999, available at <https://www.wired.com/1999/01/sun-on-privacy-get-over-it/> (last visited September 26, 2019).+(last+visited+September+26,+2019).>Google Scholar
While not a case about DNA or genetic testing, the Supreme Court in California v. Greenwood, held a defendant has no reasonable expectation of privacy over trash left for pick-up on the curb outside the defendant's home. Law enforcement may, therefore, search or seize this trash without a warrant. 486 U.S. 35, 35 (1988). Subsequent courts have applied similar reasoning to cases of “abandoned DNA.” See People v. Gallego, 117 Cal. Rptr. 3d 907, 912-914 (Cal. Ct. App. 2012) (finding the DNA testing of a cigarette the defendant threw on sidewalk not a Fourth Amendment search); Commonwealth v. Cabral, 866 N.E.2d 429, 435 (Mass. App. Ct. 2007) (finding no reasonable expectation of privacy over saliva, and DNA obtained from it, spit on the ground); State v. Athan, 158 P.3d 27, 33-34 (Wash. 2007) (holding that the defendant had no expectation of privacy over DNA obtained from saliva on an envelope he licked and placed in the mail).Google Scholar
Gardner, E., “Marvel Chairman Ike Perlmutter Allowed to Pursue Legal Claims over Theft of his DNA,” The Hollywood Reporter, January 25, 2017, available at <https://www.holly-woodreporter.com/thr-esq/marvel-chairman-ike-perlmutter-allowed-pursue-legal-claims-theft-his-dna-968493> (last visited September 20, 2019) (Florida state trial court allows claim to proceed that plaintiff had a property interest in his DNA and its associated information that one neighbor allegedly intentionally stole during a deposition in order to compare it with DNA found on hate mail sent to the plaintiffs). See also Brown, K.V., “How a Legal Brawl Between Two Rich Guys Could Change How We Think About DNA,” Gizmodo, June 13, 2018, at <https://gizmodo.com/how-a-legal-brawl-between-two-rich-guys-could-change-ho-1824191082> (last visited September 2, 2019).+(last+visited+September+20,+2019)+(Florida+state+trial+court+allows+claim+to+proceed+that+plaintiff+had+a+property+interest+in+his+DNA+and+its+associated+information+that+one+neighbor+allegedly+intentionally+stole+during+a+deposition+in+order+to+compare+it+with+DNA+found+on+hate+mail+sent+to+the+plaintiffs).+See+also+Brown,+K.V.,+“How+a+Legal+Brawl+Between+Two+Rich+Guys+Could+Change+How+We+Think+About+DNA,”+Gizmodo,+June+13,+2018,+at++(last+visited+September+2,+2019).>Google Scholar
J. Roberts, supra note 35, at 1128.Google Scholar
Supra note 16.Google Scholar
Farr, C., “Consumer DNA Testing Has Hit a Lull – Here's How It Could Capture the Next Wave of Users,” CNBC, Aug. 25, 2019, available at <https://www.cnbc.com/2019/08/25/dna-tests-from-companies-like-23andme-ancestry-see-sales-slowdown.html> (last visited September 26, 2019). (Quoting sources who suggested as reasons for the lull either saturating markets or privacy concerns.) (last visited September 26, 2019). (Quoting sources who suggested as reasons for the lull either saturating markets or privacy concerns.)' href=https://scholar.google.com/scholar?q=Farr,+C.,+“Consumer+DNA+Testing+Has+Hit+a+Lull+–+Here's+How+It+Could+Capture+the+Next+Wave+of+Users,”+CNBC,+Aug.+25,+2019,+available+at++(last+visited+September+26,+2019).+(Quoting+sources+who+suggested+as+reasons+for+the+lull+either+saturating+markets+or+privacy+concerns.)>Google Scholar
Garde, D., “Illumina Earnings Point to Worrying Signs for Consumer Genetics Industry,” Stat+, July 12, 2019, available at <https://www.statnews.com/2019/07/12/illumina-earnings-points-to-worrying-signs-for-consumer-genetics-industry/> (last visited September 2, 2019).+(last+visited+September+2,+2019).>Google Scholar
Brown, K.V., “App Store for DNA Fizzles as Health Startup Shifts Strategy,” Bloomberg, May 8, 2019, available at <https://www.bloomberg.com/news/articles/2019-05-08/-app-store-for-dna-fizzles-as-health-startup-shifts-strategy> (last visited September 2, 2019).+(last+visited+September+2,+2019).>Google Scholar
Pickrell, J., “Sunsetting Glencove for Individuals,” The Glen-cove Blog, May 18, 2018, available at <https://medium.com/the-gencove-blog/sunsetting-gencove-for-individuals-7d24f951193c> (last visited September 2, 2019). See also S.C. Nelson (2019), supra note 21. Another possibly interesting omen comes from 23andMe, which has announced that it is expanding its business into helping to provide clinical trial cohorts for pharmaceutical or biotechnology companies. See Robbins, R., 23andMe, “Moving Beyond Consumer DNA Tests, Is Building a Clinical Trial Recruitment Business,” Stat+, September 26, 2019), available at <https://www.statnews.com/2019/09/26/23andme-clinical-trial-recruitment/> (last visited October 8, 2019). This follows 23andMe's earlier efforts to become a drug discovery and development company, efforts that have not yet borne any fruit.+(last+visited+September+2,+2019).+See+also+S.C.+Nelson+(2019),+supra+note+21.+Another+possibly+interesting+omen+comes+from+23andMe,+which+has+announced+that+it+is+expanding+its+business+into+helping+to+provide+clinical+trial+cohorts+for+pharmaceutical+or+biotechnology+companies.+See+Robbins,+R.,+23andMe,+“Moving+Beyond+Consumer+DNA+Tests,+Is+Building+a+Clinical+Trial+Recruitment+Business,”+Stat+,+September+26,+2019),+available+at++(last+visited+October+8,+2019).+This+follows+23andMe's+earlier+efforts+to+become+a+drug+discovery+and+development+company,+efforts+that+have+not+yet+borne+any+fruit.>Google Scholar
Aldhouse, P., “This Genealogy Database Helped Solve Dozens of Crimes. But Its New Privacy Rules Will Restrict Access Cops,” BuzzFeed News, May 19, 2019, available at <https://www.buzzfeednews.com/article/peteraldhous/this-genealogy-database-helped-solve-dozens-of-crimes-but> (last visited September 26, 2019).+(last+visited+September+26,+2019).>Google Scholar
Zhang, S., “The Messy Consequences of the Golden State Killer Case,” The Atlantic, October 1, 2019, available at <https://www.theatlantic.com/science/archive/2019/10/genetic-genealogy-dna-database-criminal-investigations/599005/> (last visited October 8, 2019).+(last+visited+October+8,+2019).>Google Scholar
Email from GEDMatch Notifications to author (HG, ), subject line “Important GEDmatch Message,” September 12, 2019.Google Scholar
Marcus, A.D., “Customers Handed Over Their DNA. The Company Let the FBI Take a Look,” Wall Street Journal, August 22, 2019, available at <https://www.wsj.com/articles/customers-handed-over-their-dna-the-company-let-the-fbi-take-a-look-11566491162> (last visited October 3, 2019).+(last+visited+October+3,+2019).>Google Scholar
Begley, S., “Amid Privacy Concerns, Startup Becomes First Consumer DNA Company to Offer Anonymous Sequencing,” Stat+, September 19, 2019, available at <https://www.statnews.com/2019/09/19/nebula-to-offer-anonymous-dna-sequencing> (last visited September 26, 2019).+(last+visited+September+26,+2019).>Google Scholar
U.S. Dept. of Justice, “Interim Policy: Forensic Genealogical DNA Analysis and Searching (approved September 2, 2019),” available at <justice.gov/olp/page/file/1204386/download> (last visited October 8, 2019).+(last+visited+October+8,+2019).>Google Scholar
GenomeWeb, “FBI Approves ANDE Rapid DNA ID System,” GenomeWeb, June 4, 2018, available at <https://www.genomeweb.com/applied-markets/fbi-approves-ande-rapid-dna-id-system#.XY74RudKiHo> (last visited September 27, 2019).+(last+visited+September+27,+2019).>Google Scholar
Kolata, G., “‘Devious Defecator’ Case Tests Genetics Law,” The New York Times, May 29, 2015, available at <https://www.nytimes.com/2015/06/02/health/devious-defecator-case-tests-genetics-law.html> (last visited September 26, 2019); Lowe v. Atlas Logistics Group Retail Services, 102 F. Supp. 2d 1360, (N.D. Ga. 2015).+(last+visited+September+26,+2019);+Lowe+v.+Atlas+Logistics+Group+Retail+Services,+102+F.+Supp.+2d+1360,+(N.D.+Ga.+2015).>Google Scholar