Risks of Presymptomatic Direct-to-Consumer Genetic Testing | Health Policy and Reform

Perspective
Risks of Presymptomatic Direct-to-Consumer Genetic Testing
NEJM | August 18, 2010 | Topics: Health Care Delivery

Justin P. Annes, M.D., Ph.D., Monica A. Giovanni, M.S., C.G.C. and Michael F. Murray, M.D.

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

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Risks of Presymptomatic Direct-to-Consumer Genetic Testing | Health Policy and Reform