SciPulse Perspectives: Scientists Are Divided Over Direct-To-Consumer (DTC) Genetics Regulation

sCiPulse Perspectives SCIENTISTS ARE DIVIDED Over Direct-To-Consumer (DTC) Genetics Regulation 23andMe claims to have genotyped 64% of respondents have either ordered a direct-to-consumer test for themselves, or would consider doing so in the future. We asked 500 of our members how they felt about the FDA's recent warning to 23andMe, barring the consumer genetic testing company from providing individual interpretation of their customers' results. The more than 500,000 FDA argues that there is a potential for harm when individuals. genetic testing results are presented without the counsel of a physician. Our members were divided on the subject. mediacenter.23andme. com/factsheet/ 12% have would already- 52% consider it 53% 40% 26% 43% 44% are concerned about the 35% No 43% Yes potential for harm. 43% believe that the FDA 22% Uncertain Regulating Health Prediction in the Future made the right decision to stop 23andMe from providing genetic interpretations directly to individuals without involving an 30% intermediary physician for counsel. 17% As health and diagnostic technologies become more accessible to consumers, should the FDA further extend regulations regarding these sorts of technologies (mobile health applications, fitness trackers, health risk prediction software)? 66% say YES Yes, but only a subset of these products and technologies need significant regulation. Age plays a role among those opposed to future regulation: Younger scientists tend to fear increased regulation would hamper innovation. No, increased regulation will have a deleterious effect on these 50% 14% important innovations. 18% No, consumers should have access to as much personalized medical information as possible. • Older scientists tend to feel that 16% Yes, there is a significant lack of regulation in this area. people should have unregulated access to their own genetic information. 2% Other/ None of the above The Science Advisory Board 73% of respondents hold an advanced degree (MD or PhD). BY NC ND 100% of respondents are members of The Science Advisory Board. Join us today and take part in crafting future SciPulse Perspectives! Visit us at

SciPulse Perspectives: Scientists Are Divided Over Direct-To-Consumer (DTC) Genetics Regulation

shared by LRM on Jun 06
In this project, we asked 500 U.S. scientists to share their views on the Direct-to-Consumer testing industry, specifically in the context of the FDA's warning letter to 23andMe, Inc. in November of ...


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