Direct-to-Consumer Testing 2.0: Emerging Models of Direct-to-Consumer Genetic Testing
Open accessAbstract
Direct-to-consumer (DTC) genetic testing emerged in the early 2000s as a means of allowing consumers to access information on their genetics without the involvement of a physician. Although early models of DTC were popular with consumers, they were controversial in medical and regulatory circles. In this article, we trace the history of DTC genetic testing, discuss its regulatory implications, and describe the emergence of a new hybrid model we call DTC 2.0.
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The direct-to-consumer testing market has expanded, is variably controlled by country-specific regulations, and is moving toward models with direct access to ordering physicians and genetic counselors.
“One consequence of these difficulties has been an expanding direct-to-consumer testing market, variably controlled by country-specific regulations150, which is moving beyond a focus on ancestry and personal traits, towards models in which individuals have direct access to ordering physicians and genetic counselors151.”
From A brief history of human disease genetics (2020) · cites this paper as [151]
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- Authors
- Allyse, M. A., Robinson, D. H., Ferber, M. J., & Sharp, R. R.
- Affiliations
- Mayo Clinic (US)
- Corresponding author
- Sharp, Richard R.
- Venue
- Mayo Clinic Proceedings
- Publisher
- Elsevier BV
- Published
- 2018-01
- Volume
- 93
- Issue
- 1
- Pages
- 113-120
- ISSN
- 0025-6196 (ISSN-L)
- OpenAlex
- W2781996111
- Cited by
- 139
- References
- 20
- Citations by year
- 2026: 3 · 2025: 13 · 2024: 16 · 2023: 10 · 2022: 18 · 2021: 22 · 2020: 31 · 2019: 18 · 2018: 8
- FWCI
- 13.63
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Mayo Clinic Proceedings (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Center for Individualized Medicine, Mayo Clinic
- Topics
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Medical and Health Sciences Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Race, Genetics, and Society
- Keywords
- direct-to-consumer genetic testing, genetic testing regulation, hybrid business models, genetic counseling
- MeSH terms
- Direct-To-Consumer Screening and Testing, Computer-Assisted Instruction, Curriculum, Education, Medical, Continuing, Genetic Testing, Humans, Minnesota, History, 21st Century
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