Where are you going, where have you been: a recent history of the direct-to-consumer genetic testing market
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REVIEW
Where are you going, where have you been: a recent history of the direct-to-consumer genetic testing market Pascal Borry & Martina C. Cornel & Heidi C. Howard
Received: 18 August 2010 / Accepted: 24 September 2010 / Published online: 8 October 2010 # The Author(s) 2010. This article is published with open access at Springerlink.com
Abstract In recent years, various private companies have been marketing and offering genetic tests directly to consumers. This article reviews the recent history of this commercial phenomenon. In particular, we discuss and describe the following subjects: (1) the factors that allowed for the creation of the direct-to-consumer (DTC) genetic testing (GT) market; (2) information regarding the size and potential success or failure of the DTC GT market; (3) recent changes in the DTC GT market; and (4) the recent events that may have an impact on the regulatory oversight of DTC genetic testing and the future evolution of this market. This review of factors suggests that despite the possibility of a change of business model as well as increased regulation, the commercialization of genetic testing is here to stay. As such it is important to pay close attention not only to the science underlying these tests but also to the ethical, legal, and social issues.
P. Borry : H. C. Howard Centre for Biomedical Ethics and Law, Katholieke Universiteit Leuven, Kapucijnenvoer 35, P.O. Box 7001, 3000 Leuven, Belgium P. Borry Department of Medical Humanities, VU University Medical Center, EMGO Institute for Health and Care Research, Amsterdam, The Netherlands P. Borry (*) : M. C. Cornel Department of Clinical Genetics, VU University Medical Center, EMGO Institute for Health and Care Research, P.O. Box 7057, 1007 MB Amsterdam, The Netherlands e-mail: [email protected]
Introduction A decade ago, Francis Collins and Victor McKusick predicted that “by the year 2010, it is expected that predictive genetic tests will be available for as many as a dozen common conditions, allowing individuals who wish to know this information to learn their individual susceptibilities and to take steps to reduce those risks for which interventions are or will be available” (Collins and McKusick 2001). They predicted that with the increase of genetic information about common disorders, many primary care clinicians would become “practitioners of genomic medicine, having to explain complex statistical risk information to healthy individuals who are seeking to enhance their chances of staying well.” However, with respect to common disorders and susceptibility testing, the anticipated increase of genomic science in the traditional healthcare system has not materialized. In fact, it is private companies who are taking the lead and marketing susceptibility tests directly to consumers. Furthermore, according to some authors, commercial companies may even “come to displace clinicians as the primary providers of genetic information related to health promotion” (Foster and Sharp 2008). Indeed, in the last 3 years, many comp
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