Michael F. Murray, MD
This article was published online first at www.annals.org on 11 February 2014.
Potential Conflicts of Interest: None disclosed. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-2804.
Requests for Single Reprints: Michael F. Murray, MD, Genomic Medicine Institute, 100 North Academy Avenue, MC 26-20, Danville, PA 17822; e-mail, firstname.lastname@example.org.
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.
Murray MF. Why We Should Care About What You Get for “Only $99” From a Personal Genomic Service. Ann Intern Med. 2014;160:507-508. doi: 10.7326/M13-2804
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Published: Ann Intern Med. 2014;160(7):507-508.
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 any assurance that the firm had analytically or clinically validated the PGS for its intended uses” (1). This commentary focuses on some elements of the broader context in which this dispute between the FDA and 23andMe is occurring.
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