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Direct-to-consumer genetic testing: Current status and future implications


Two expert commentaries provide perspective on FDA’s recent warning to 23andMe, a direct-to-consumer (DTC) genetic testing company, regarding testing and health-related information offered by the company. Commentary authors pointed out the need to ensure such testing is clinically valid and provided in a manner that supports patient privacy, informed consent, and medical interpretation of test results. Additionally, authors cited whole-genome sequencing technology as an emerging clinical alternative.


Annas GJ et al. 23andMe and the FDA [perspective]. N Engl J Med. 2014;370:985–988.

Zettler PJ et al. 23andMe, the Food and Drug Administration, and the future of genetic testing [viewpoint]. JAMA Intern Med. 2014;174(4):493–494.