Why We Should Care About What You Get for “Only $99” From a Personal Genomic Service
Authors: Michael F. Murray
Journal: Annals of Internal Medicine (2014)

Ideas and Opinions1 April 2014Why We Should Care About What You Get for "Only $99" From a Personal Genomic ServiceMichael F. Murray, MDMichael F. Murray, MDFrom the Genomic Medicine Institute, Geisinger Health System, Danville, Pennsylvania.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M13-2804 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In August 2013, 23andMe (Mountain View, California; www.23andme.com) launched an advertising campaign to sell its personal genome service (PGS) for "only $99" (www.youtube.com/watch?v=ToloqU6fCjw; accessed on 30 November 2013). This campaign is part of the company's marketing effort to reach a stated goal of growing to serve greater than 1 million customers. However, that plan hit a hurdle when the U.S. Food and Drug Administration (FDA) issued a warning letter on 22 November 2013 instructing the company to "immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device" because the FDA did not "have ...References1. U.S. Food and Drug Administration. Inspections, Compliance, Enforcement, and Criminal Investigations: 23andMe, Inc. 11/22/13. Warning letter. Accessed at www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm on 30 November 2013. Google Scholar2. Annes JP, Giovanni MA, Murray MF. Risks of presymptomatic direct-to-consumer genetic testing. N Engl J Med. 2010;363:1100-1. [PMID: 20843242] CrossrefMedlineGoogle Scholar3. European Society of Human Genetics. Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes. Eur J Hum Genet. 2010;18:1271-3. [PMID: 20736974] CrossrefMedlineGoogle Scholar4. Seife C. 23andMe is terrifying, but not for the reasons the FDA thinks: the genetic-testing company's real goal is to hoard your personal data. Scientific American. 27 November 2013. Accessed at www.scientificamerican.com/article.cfm?id=23andme-is-terrifying-but-not-for-reasons-fda on 1 December 2013. Google Scholar5. 23andMe Statement Regarding FDA Warning Letter [press release]. 25 November 2013. Accessed at http://mediacenter.23andme.com/press-releases/fda-letter-2013 on 1 December 2013. Google Scholar6. Su P. Direct-to-consumer genetic testing: a comprehensive view. Yale J Biol Med. 2013;86:359-65. [PMID: 24058310] MedlineGoogle Scholar7. Personal Genome Project. Accessed at www.personalgenomes.org on 1 December 2013. Google Scholar8. Kim JK, Rho J, Prasad V. Handheld ultrasounds: pocket sized, but pocket ready? [Editorial]. Am J Med. 2013;126:845-6. [PMID: 23910521] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Michael F. Murray, MDAffiliations: From the Genomic Medicine Institute, Geisinger Health System, Danville, Pennsylvania.Disclosures: None disclosed. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2804.Corresponding Author: Michael F. Murray, MD, Genomic Medicine Institute, 100 North Academy Avenue, MC 26-20, Danville, PA 17822; e-mail, mfmurray1@geisinger.edu.Author Contributions: Conception and design: M.F. Murray.Analysis and interpretation of the data: M.F. Murray.Drafting of the article: M.F. Murray.Critical revision of the article for important intellectual content: M.F. Murray.Final approval of the article: M.F. Murray.Administrative, technical, or logistic support: M.F. Murray.Collection and assembly of data: M.F. Murray.This article was published online first at www.annals.org on 11 February 2014. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byPersonal Genomic Testing for Cancer Risk: Results From the Impact of Personal Genomics StudyEducational Issues and Strategies for Genomic Medicine23andme: The Business and Ethics of Personal Genetics Testing'Someday it will be the norm': physician perspectives on the utility of genome sequencing for patient care in the MedSeqProjectDo physicians think genomic medicine will be useful for patient care? 1 April 2014Volume 160, Issue 7Page: 507-508KeywordsFood and Drug AdministrationGenetic testingGenomicsHealth careHealth care providersHealth economicsInflammatory bowel diseasePatientsResearch designSaliva ePublished: 1 April 2014 Issue Published: 1 April 2014 Copyright & PermissionsCopyright © 2014 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...