title: Direct-to-consumer genetic testing: good, bad or benign?
abstract: A wide variety of genetic tests are now being marketed and sold in direct-to-consumer (DTC) commercial transactions. However, risk information revealed through many DTC testing services, especially those based on emerging genome wide-association studies, has limited predictive value for consumers. Some commentators contend that tests are being marketed prematurely, while others support rapid translation of genetic research findings to the marketplace. The potential harms and benefits of DTC access to genetic testing are not yet well understood, but some large-scale studies have recently been launched to examine how consumers understand and use genetic risk information. Greater consumer access to genetic tests creates a need for continuing education for health care professionals so they can respond to patients' inquiries about the benefits, risks and limitations of DTC services. Governmental bodies in many jurisdictions are considering options for regulating practices of DTC genetic testing companies, particularly to govern quality of commercial genetic tests and ensure fair and truthful advertising. Intersectoral initiatives involving government regulators, professional bodies and industry are important to facilitate development of standards to govern this rapidly developing area of personalized genomic commerce.
authors.affiliation: Faculty of Law, School of Public Health, University of Alberta, Edmonton, Alberta, Canada. tcaulfld@law.ualberta.ca
authors.forename: T
authors.initials: T
authors.lastname: Caulfield
authors.forename: N M
authors.initials: NM
authors.lastname: Ries
authors.forename: P N
authors.initials: PN
authors.lastname: Ray
authors.forename: C
authors.initials: C
authors.lastname: Shuman
authors.forename: B
authors.initials: B
authors.lastname: Wilson
mesh_terms: D005820:Genetic Testing / Q000941:ethics / Q000379:methods* / Q000523:psychology; D006801:Humans