The Current Landscape for Direct-to-Consumer Genetic Testing: Legal, Ethical, and Policy Issues
Stuart Hogarth,1 Gail Javitt,2 and David Melzer31Department of Social Sciences, Loughborough University, Loughborough LE11 3TU, United Kingdom; email:
s.hogarth@lboro.ac.uk 2Genetics and Public Policy Center, Johns Hopkins University, Washington, DC 20036; email:
gjavitt1@jhu.edu 3Epidemiology and Public Health Group, Peninsula Medical School, Exeter EX2 5DW, United Kingdom; email:
david.melzer@pms.ac.uk This review surveys the developing market for direct-to-consumer (DTC) genetic tests and examines the range of companies and tests available, the regulatory landscape, the concerns raised about DTC testing, and the calls for enhanced oversight. We provide a comparative overview of the situation, particularly in the United States and Europe, by exploring the regulatory frameworks for medical devices and clinical laboratories. We also discuss a variety of other mechanisms such as general controls on advertising and consumer law mechanisms.
Acronyms and Definitions
ACGT: Advisory Committee on Genetic Testing
Analytic validity: the accuracy with which a given laboratory test identifies a particular genetic variant
ASA: Advertising Standards Authority
CLIA: Clinical Laboratory Improvements Amendments
Clinical utility: the likelihood that using the test result(s) will lead to a beneficial outcome
Clinical validity: the accuracy with which a test predicts a particular clinical outcome
CMS: Centers for Medicare and Medicaid Services
DTC: direct to consumer
FDA: Food and Drug Administration
FTC: Federal Trade Commission
GAO: Government Accountability Office
HGC: Human Genetics Commission
IVD: in vitro diagnostic
IVDMIA: in vitro diagnostic multivariate index assay
Laboratory-developed test (LDT): test developed for in-house use by a clinical laboratory
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