Importance of Accuracy
Jeremy Gruber, president of the Council for Responsible Genetics, proposed that DTC require more regulation to protect consumers; the Council for Responsible Genetics is a public policy group focused on the social, ethical, and environmental implications of genetic technologies.
“We believe everyone should have access to their genome and be able to sequence it if they choose,” Gruber said in testimony to the panel. “What we do feel strongly about, however, is that people shouldn’t be misled about the significance of that information and that people should be able to be assured that the claims that are made are accurate and that their privacy will be protected.”
Pendergast agreed about the need for accuracy in testing but said reports of anxiety resulting from false-positive tests “are usually anecdotal and overblown, and most of the recent research about the psychological impact of DTC genetic testing demonstrates that anxiety, if it occurs, is transient.”
She said doctors and patients will both need to get up to speed on genetic testing: “We are entering an era of personalized medicine where the treatments used will vary depending, in part, on the genetic signature of the patient. For the country to move to this more-focused treatment paradigm, it will be important to educate the public, and the medical professionals could play a useful role in education.”
The issue of accuracy of DTC genetic tests was raised last year in a report by the General Accountability Office (GAO). It concluded that four sellers of DTC genetic tests—23andMe, Decode Genetics, Navigenics, and Pathway Genomics—offered contradictory risk predictions for at least nine diseases for each of five fictitious customers.
GAO said it submitted to the companies one true set and one false set of DNA data for each customer and found that follow-up consultations lacked expert advice. Representatives of the genetic testing industry have criticized the report’s methodology as unscientific and its findings as misleading.
FDA’s Molecular & Clinical Genetics Panel shared GAO’s and Gruber’s concern about accuracy by testing companies. Options discussed ranged from patient education and training to clear labeling, online videos, training of professionals, as well as health provider input into the results. The panel’s summary, however, showed no agreement on which one or more options the FDA should pursue.