Current Ethical and Legal Issues in Health-Related Direct-To-Consumer Genetic Testing | Zendy

Emilia Niemiec | Zendy; Louiza Kalokairinou | Zendy; Heidi Howard | Zendy

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Current Ethical and Legal Issues in Health-Related Direct-To-Consumer Genetic Testing

Author(s) -

Emilia Niemiec,

Louiza Kalokairinou,

Heidi Howard

Publication year - 2017

Publication title -

personalized medicine

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.489

H-Index - 31

eISSN - 1744-828X

pISSN - 1741-0541

DOI - 10.2217/pme-2017-0029

Subject(s) - genetic testing , commercialization , ethical issues , variety (cybernetics) , bioethics , medicine , informed consent , diagnostic test , engineering ethics , risk analysis (engineering) , business , marketing , computer science , genetics , alternative medicine , pathology , biology , engineering , emergency medicine , artificial intelligence

A variety of health-related genetic testing is currently advertized directly to consumers. This article provides a timely overview of direct-to-consumer genetic testing (DTC GT) and salient ethical issues, as well as an analysis of the impact of the recently adopted regulation on in vitro diagnostic medical devices on DTC GT. DTC GT companies currently employ new testing approaches, report on a wide spectrum of conditions and target new groups of consumers. Such activities raise ethical issues including the questionable analytic and clinical validity of tests, the adequacy of informed consent, potentially misleading advertizing, testing in children, research uses and commercialization of genomic data. The recently adopted regulation on in vitro diagnostic medical devices may limit the offers of predisposition DTC GT in the EU market.

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