Healthy Skepticism Library item: 18711

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Annes JP, Giovanni MA, Murray MF.
Risks of presymptomatic direct-to-consumer genetic testing.
N Engl J Med 2010 Sep 16; 363:(12):1100-1
http://www.nejm.org/doi/full/10.1056/NEJMp1006029

Abstract:

Geneticists have long cited the risks of direct-to-consumer (DTC) genetic testing, highlighting the danger for consumers who make complex medical decisions without adequate clinical guidance. On May 10, 2010, the Food and Drug Administration (FDA) voiced its concern by sending a letter informing Pathway Genomics that its DNA testing and interpretation service “appears to meet the definition of a device” and may therefore require FDA approval.(1) The letter was prompted by the announcement by Pathway Genomics and Walgreens of the impending marketing of an over-the-counter testing kit to analyze genetic risk and provide information regarding more than 70 diseases or …

Keywords:
Aryl Hydrocarbon Hydroxylases/geneticsnDevice Approval*nGenetic Predisposition to DiseasenGenetic Testing/legislation & jurisprudence*nGenetic Testing/standardsnGovernment RegulationnHumansnUnited StatesnUnited States Food and Drug Administration