Direct to consumer genetic testing and personalized medicine: Summary of issues and recommendations from the Secretary's Advisory Committee on Genetics, Health and Society

Direct-to-consumer (DTC) genetic testing has been of interest to the Secretary's Advisory Committee on Genetic, Health, and Society (SACGHS) since its inaugural meeting in June 2003. With the growth in DTC genetic testing, SACGHS chose to develop a report to explore the risks and benefits of this approach to genetic services. The report focuses on outlining the issues that may help consumers in using the services of companies that offer DTC genetic testing and in making informed decisions based on the information from test results. The report also highlights recommendations from past SACGHS reports that addressed concerns about genetic testing regardless of the route in which they are delivered (i.e., DTC or through a consumer's personal health care provider). The intent of the recommendations is to ensure that standards for DTC genetic tests harmonize with standards for provider-based genetic tests, with the recognition that deficiencies exist in the delivery and oversight of provider-based laboratory testing. The report also identifies potential concerns for DTC genetic testing when a consumer's personal health provider is not involved in health decisions or if government regulations do not apply to entities providing this type of testing. These additional concerns may be considered in the future by SACGHS for the development of new recommendations specific to DTC genetic testing.