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Direct-to-Consumer Genetic Testing: A Comprehensive Review.

Sharon Jiang1,2, Lawrence Liberti3, David Lebo3

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Summary
This summary is machine-generated.

Direct-to-consumer (DTC) genetic testing offers accessible health insights but raises accuracy and privacy concerns. A hybrid model emerges, balancing DTC convenience with clinical oversight for genetic information.

Keywords:
Clinical testDTC genetic testDTC genetic test regulationDirect-to-consumerGenetic testing

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Area of Science:

  • Genetics
  • Bioethics
  • Consumer Health

Background:

  • Direct-to-consumer (DTC) genetic testing emerged in the early 2000s, enabling individuals to access genetic information without healthcare provider involvement.
  • This contrasts with traditional clinical genetic testing, where healthcare professionals manage the entire process from ordering to result interpretation.
  • The accessibility and affordability of online DTC testing have driven its popularity, empowering consumers in health and lifestyle decisions.

Purpose of the Study:

  • To review the fundamental concepts, applications, benefits, and limitations of DTC genetic testing.
  • To examine consumer concerns, data security, and privacy issues associated with DTC genetic testing.
  • To compare the DTC model with clinical-based and emerging hybrid genetic testing models, including regulatory frameworks in the US.

Main Methods:

  • Literature review and analysis of existing frameworks.
  • Examination of consumer-facing genetic testing platforms.
  • Analysis of regulatory policies and ethical considerations in the US.

Main Results:

  • DTC genetic tests provide insights into genetic predispositions, not diagnoses, encouraging consumer-provider discussions.
  • Concerns persist regarding result accuracy, data security, and privacy.
  • A hybrid model is emerging to integrate DTC accessibility with clinical validation.

Conclusions:

  • DTC genetic testing empowers consumers but requires careful consideration of its limitations and risks.
  • Regulatory oversight and data protection are critical for responsible DTC genetic testing.
  • The evolving landscape includes hybrid models addressing current DTC challenges and enhancing consumer genetic information access.