Direct‐to‐consumer genetic testing: good, bad or benign?

Abstract

A wide variety of genetic tests are now being marketed and sold in direct-to-consumer (DTC) commercial transactions. However, risk information revealed through many DTC testing services, especially those based on emerging genome wide-association studies, has limited predictive value for consumers. Some commentators contend that tests are being marketed prematurely, while others support rapid translation of genetic research findings to the marketplace. The potential harms and benefits of DTC access to genetic testing are not yet well understood, but some large-scale studies have recently been launched to examine how consumers understand and use genetic risk information. Greater consumer access to genetic tests creates a need for continuing education for health care professionals so they can respond to patients' inquiries about the benefits, risks and limitations of DTC services. Governmental bodies in many jurisdictions are considering options for regulating practices of DTC genetic testing companies, particularly to govern quality of commercial genetic tests and ensure fair and truthful advertising. Intersectoral initiatives involving government regulators, professional bodies and industry are important to facilitate development of standards to govern this rapidly developing area of personalized genomic commerce.

The perspective from EASAC and FEAM on direct-to-consumer genetic testing for health-related purposes

“…Such advice complements the other, intersectoral, initiatives involving public regulators, specialist professional bodies and industry, aiming to develop and implement a practical framework to govern and implement this rapidly developing technology. 9 Both the academy networks have significant experience in biomedical policy issues. For example, in previous work EASAC has addressed EU regulatory and innovation policy priorities in infectious disease, 10,11 synthetic biology 12 and nanotechnology.…”

Personalised nutrition: ready for practice?

“…Individuals can make their own interpretation of results without having to visit health care professionals. The health value and personal ramifications of this remain unclear (23) . A recent report from the Nuffield Council on Bioethics has stated that personalised medicine, or personalised nutrition, requires users to take responsibilities.…”

“…Because of varying regulatory oversight in different countries, consumers are warned that personal data may be used by 'interested third parties' such as employers, insurance companies and the companies releasing the genetic test results. These risks can be contained by laws preventing the disclosure of information to third parties or permitting genetic tests through health care professionals only (23) .…”

Exploring dispositional tendencies to seek online information about direct-to-consumer genetic testing

“…The emergence of commercial services that provide genetic susceptibility testing directly to consumers evokes several compelling translational research questions [1,2]. There has been considerable controversy surrounding companies offering genetic tests direct-to-consumer (DTC) [1] with greatest concerns that these tests bypass health professionals [2][3][4][5][6].…”

“…There has been considerable controversy surrounding companies offering genetic tests direct-to-consumer (DTC) [1] with greatest concerns that these tests bypass health professionals [2][3][4][5][6]. The majority of the risk information conveyed reflects small increases in risk (i.e., 10-30 % increased risk) raising questions about the utility of the information and the concern that seeking and receiving genetic information online may cause individuals to experience anxiety, distress, or other negative emotional responses [7,8].…”