Ongoing genetic discoveries and technological innovation during the past decade have appreciably expanded the availability of genetic tests related to health conditions. Concomitant with the advancement of genetic science has been the development of two trends, the marketing of genetic tests directly to consumers (i.e., through paid advertisements in print media, television, and the Internet) and the direct availability of genetic tests to consumers (i.e., through the Internet) [1
]. Regarding the latter, consumers can purchase genetic tests, often without involving their health care provider, that indicate personal risk for conditions ranging from trivial characteristics (e.g., earwax type) to serious health conditions (e.g., breast cancer, Alzheimer's disease) [1
Both the direct marketing of genetic tests and their direct-to-consumer (DTC) availability have been controversial [4
], with an increasing volume of health scholarship devoted to the topic [1
]. While proponents of DTC tests argue that individuals should have the right to access their genetic information in a private setting (without going through the traditional health care setting), critics argue that DTC genetic testing has significant risks, both to the individuals and to the health care system [1
Since 2010, several regulatory actions have been taken in the United States with regard to DTC genetic testing, including letters to companies by the Food and Drug Administration and reports produced by the Government Accountability Office [3
]. A fully informed policy analysis of the benefits and potential harms of DTC genetic testing is impossible without understanding the extent of consumer demand for, use of, and psychosocial and behavioral response to these services [2
]. Awareness of DTC services is a necessary precursor to demand, as consumers (with rare exceptions, as when services are purchased as a gift) must be aware of the existence of these services before pursuing them. A systematic population-level assessment of awareness of DTC services reveals the extent of public interest in these services and the reach of marketing, which can help policymakers predict whether the risks and benefits of DTC genetic testing will be confined to a narrow subpopulation of consumers or is a more widespread population concern. Prior research examining awareness of DTC genetic testing has documented variability in overall levels of awareness and by geographic location, age, income, and education [11
]. Limitations of prior research stem from the lack of national samples [11
] and failure to more fully explore demographic, behavioral, and geographic covariates of awareness to facilitate a more complete understanding of the implications of DTC marketing activities.
The Health Information National Trends Survey sought to fill this research gap by including a question about awareness of DTC genetic test marketing on a nationally representative survey platform [16
]. Prior analysis of the 2008 Health Information National Trends Survey (HINTS) data explored associations of awareness with numeracy and identified racial and ethnic differences [16
]. Our research provides a more detailed analysis of the 2008 data and includes analysis of 2011 HINTS data to explore trends in awareness over time.
Specifically, our research assesses changes in awareness of DTC genetic testing in the US population and explores factors associated with awareness including sociodemographic characteristics, cancer history, health care access, Internet use, and geographic differences. We focus on these factors for a variety of reasons. First, many of the currently available DTC genetic testing companies offer cancer risk testing as a major component of their service; in fact, the first major DTC multimedia advertising campaign for a genetic test was for breast cancer [17
]. We included prior cancer diagnosis and family history of cancer in our analyses to explore whether individuals with particular interest in cancer are more aware of these services and thus may be part of the potential market for these services. Second, while proponents of DTC genetic testing have suggested that this mode of testing might facilitate greater access to genetic services in underserved areas [18
], this has not yet been empirically examined. If awareness of these services is confined to urban areas and individuals who already have more health care access, then DTC genetic testing could exacerbate already-existing disparities in health care resources. Third, the majority of DTC genetic testing marketing efforts occur on-line. Thus, we were interested in exploring whether use of the Internet was associated with awareness of DTC genetic testing. Finally, given the unequal distribution of high speed Internet access in the USA with particular disparities in rural America, and the urban-focused efforts of traditional media marketing campaigns, we sought to discern whether there were differences in awareness of DTC genetic testing by population density [19