23andMe Paves the Way for Direct-to-Consumer Genetic Health Risk Tests of Limited Clinical Utility

Ideas and Opinions18 July 201723andMe Paves the Way for Direct-to-Consumer Genetic Health Risk Tests of Limited Clinical UtilityJulia Wynn, MS and Wendy K. Chung, MD, PhDJulia Wynn, MSFrom Columbia University, New York, New York.Search for more papers by this author and Wendy K. Chung, MD, PhDFrom Columbia University, New York, New York.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M17-1045 Annals Author Insight Video - Wendy Chung, MD, PhD, and Julia Wynn, MS, CGC In this video, Wendy Chung, MD, PhD, and Julia Wynn, MS, CGC, offer additional insight into the article, "23andMe Paves the Way for Direct-to-Consumer Genetic Health Risk Tests of Limited Clinical Utility." SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In April 2017, the U.S. Food and Drug Administration (FDA) authorized 23andMe's direct-to-consumer (DTC) genetic test (1). This approval raises concerns about the clinical standards to which DTC genetic testing will be held. The FDA also plans to exempt other 23andMe genetic health risk (GHR) tests from premarket review and indicated that companies offering similar tests may be able to forgo regulatory review after submitting the first premarket notification. These actions mark a major shift in FDA policy and open the door for broad DTC genetic testing.In 2013, the FDA ordered 23andMe to stop offering genetic screening that claimed ...References1. FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions [press release]. Silver Spring: U.S. Food and Drug Administration; 6 April 2017. Accessed at www.fda.gov/newsevents/newsroom/pressannouncements/ucm551185.htm on 12 May 2017. Google Scholar2. Gutierrez A; U.S. Food and Drug Administration. Warning letter to 23andMe (Ann Wojcicki) on Personal Genome Service. 22 November 2013. Document no. GEN1300666. Accessed at www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm on 12 May 2017. Google Scholar3. 23andMe. Good news about health reports. 6 April 2017. Accessed at https://medical.23andme.org/health-reports on 12 May 2017. Google Scholar4. Wynn J, Martinez J, Duong J, Chiuzan C, Phelan JC, Fyer A, et al. Research participants' preferences for hypothetical secondary results from genomic research. J Genet Couns. 2016. [PMID: 28035592] doi:10.1007/s10897-016-0059-2 CrossrefMedlineGoogle Scholar5. ACMG Board of Directors. Direct-to-consumer genetic testing: a revised position statement of the American College of Medical Genetics and Genomics. Genet Med. 2016;18:207-8. [PMID: 26681314] doi:10.1038/gim.2015.190 CrossrefMedlineGoogle Scholar6. NSGC releases statement calling for consumer protection in the absence of federal safeguards for DTC genetic tests [press release]. Chicago: National Society of Genetic Counselors; 27 July 2010. Accessed at www.nsgc.org/p/bl/et/blogaid=8 on 12 May 2017. Google Scholar Author, Article, and Disclosure InformationAffiliations: From Columbia University, New York, New York.Disclosures: Authors have disclosed no conflicts of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-1045.Corresponding Author: Wendy K. Chung, MD, PhD, Columbia University Medical Center, 1150 St. Nicholas Avenue, Room 620, New York, NY 10032; e-mail, [email protected]columbia.edu.Current Author Addresses: Ms. Wynn and Dr. Chung: Columbia University Medical Center, 1150 St. Nicholas Avenue, Room 620, New York, NY 10032.