Table 1. Clinical Utility of Genetic/Genomic Testsa continued...
In 2004, The American College of Medical Genetics Board of Directors asserted that genetic testing for susceptibility to disease are medical tests; therefore, these tests should be provided to the public through qualified health care professionals only. Given the complexities of genetic testing and counseling, telephone or Internet orders of home testing kits may be harmful because of the potential for inappropriate test use, misinterpretation of results, and lack of follow-up. More recently, the American Society of Human Genetics (ASHG)  provided a policy statement on DTC genetic testing, citing the need for broader oversight of laboratory assessments by the FDA and Federal Trade Commission (FTC) in order to ensure reliable tests. The ASHG statement  recommended a series of standards in the area of transparency, provider education, and test and laboratory quality, and concluded that further research and federal oversight are needed in this rapidly changing field. In 2006, the FTC and Centers for Disease Control and Prevention issued a joint statement to consumers regarding the limitations of DTC genetic tests.
Proponents of DTC marketing and provision of genetic tests often assert the putative "right to information," which they argue promotes patient autonomy. DTC marketing may increase patients' feelings of empowerment to discuss their care with their physicians. Patients may also develop an increased awareness of the importance of family history, the relationship between risk and family history, the role of genetics in disease, and a better understanding of the value of genetic counseling. While the issue of privacy is also emphasized in DTC marketing and testing claims, it may not be as salient after testing, given that those found to be positive will, for the most part, want their physician involved early in identifying measures to mitigate risk.
Research examining the impact of DTC marketing of genetic tests
Marketing of DTC genetic tests includes diverse strategies for increasing awareness and market demand for genetic testing services by for-profit companies. There are two approaches to targeting consumers with information about DTC genetic tests. The first is called DTC advertising, which promotes the availability of a genetic test to the public but requires involvement of a health care provider to order the test and disseminate the results to the consumer. The second approach, DTC genetic testing, is discussed below. While numerous position papers, review articles, and commentaries have been published, there are few empirical examples about the impact of DTC advertising of genetic tests on patients, providers, or the health care system. The most studied example to date is the Myriad Genetics campaign to increase awareness of BRCA1/2 mutation testing through multiple mass media outlets (print, radio, and television). In 2002, Myriad launched its first DTC marketing campaign in Denver and Atlanta. The target audience for this campaign was women from the general population aged 25 to 54 years. In May 2002, Myriad began with educational outreach to providers in the two cities in anticipation of patient requests for information spurred by the DTC campaign, which ran from September 2002 to February 2003. The campaign included television, radio, and print advertisements that were expected to reach greater than 90% of the target audience an average of 16 times during the 5-month period.[26,27] Subsequently, these DTC campaigns have been conducted in the northeast, Texas, and Florida. These campaigns were immediately criticized for providing incomplete, manipulative information.[28,29]