The future of direct-to-consumer clinical genetic tests

• Published in: Nature reviews. Genetics Vol. 12; no. 7; pp. 511 - 515
• Main Authors: Frueh, Felix W, Greely, Henry T, Green, Robert C, Hogarth, Stuart, Siegel, Sue
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01.07.2011; Nature Publishing Group
• Subjects: 631/208/2489/1512; Agriculture; Animal Genetics and Genomics; Behavior; Biomedical and Life Sciences; Biomedicine; Cancer Research; Clinical Laboratory Techniques - trends; Commerce - methods; Commerce - trends; Communication; Community Participation - trends; Consumers; Disease; FDA approval; Gene Function; Genetic testing; Genetic Testing - legislation & jurisprudence; Genetic Testing - methods; Genetic Testing - trends; Genetics; Health risk assessment; Heart attacks; Human Genetics; Humans; Mammography; Medical screening; Mutation; Physician-Patient Relations; United States; United States Food and Drug Administration - legislation & jurisprudence; United States Food and Drug Administration - trends; viewpoint; Web portals; United States
• ISSN: 1471-0056; 1471-0064
• DOI: 10.1038/nrg3026

Direct-to-consumer (DTC) genetic tests allow individuals to learn about their health or that of their future offspring. Should we protect individuals from potentially misleading genetic information about themselves or should we assume that adults who seek DTC services can interpret the genetic findings even without the intervention of a health professional? We present five different perspectives on whether DTC genetic tests should be regulated and, if so, how. In light of the meeting of the US Food and Drug Administration (FDA) in March 2011 to discuss the regulation of clinical direct-to-consumer (DTC) genetic tests, we have invited five experts to consider the best means of overseeing the ordering and interpretation of these tests. Should these tests be regulated? If so, who, if anyone, should communicate results to consumers?