For those in the life sciences compliance arena, we’ve been watching the rapidly emerging field of direct-to-consumer (DTC) genetic testing. Now the American College of Medical Genetics and Genomics (ACMG) has revised its earlier position statement on the topic.
“The new genomic tests being offered to the public are increasingly complex, and the results often must be placed in context with medical and family history to provide meaningful information,” said Gerald Feldman, M.D., Ph.D., FACMG, President of ACMG.
The questions ACMG suggests consumers ask are the same questions Compliance Officers need to be asking and addressing when their organizations plan to offer DTC genetic testing or partner with a laboratory and use the results for their own research or marketing purposes. These questions should include:
- Is the laboratory performing the test accredited by CLIA?
- Who will have access to the test results?
- Do you have board-certified genetic professionals available to me to help interpret the test results and answer any questions?
- What processes are in place to protect the results?
- What will happen to the DNA once testing is complete?
- Will the data be sold to or shared with any third parties?
The foundation of the revised position statement is transparency and informed consent. DTC genetic testing offers great potential to improve people’s lives, but it needs to be handled with extreme care. Compliance Officers should immediately begin reviewing or creating the necessary systems, processes and training to meet the need.