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Ideas and Opinions |1 April 2014

Why We Should Care About What You Get for “Only $99” From a Personal Genomic Service

Michael F. Murray, MD

Article, Author, and Disclosure Information
Author, Article, and Disclosure Information
This article was published online first at www.annals.org on 11 February 2014.
  • From the Genomic Medicine Institute, Geisinger Health System, Danville, Pennsylvania.

    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, 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.

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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.
So, what is 23andMe? Why does it matter to the health care system? Why does it matter to the FDA? Why might it matter to the U.S. economy? Why should it matter to physicians? 23andMe is a $126-million, privately held Silicon Valley company that was launched in 2006. The company's device is its Saliva Collection Kit and PGS. The consumers mail DNA samples (their saliva) and receive detailed analyses of their genomic data that include reports on 254 diseases and conditions. Anne Wojcicki, cofounder and chief executive officer, says that the company was created in response to frustration surrounding the realization that “the consumer is really underutilized in health...
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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: https://doi.org/10.7326/M13-2804

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Published: Ann Intern Med. 2014;160(7):507-508.

DOI: 10.7326/M13-2804

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