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Literature DB >> 18767961

The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues.

Stuart Hogarth¹, Gail Javitt, David Melzer.

Abstract

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.

Mesh：

Year: 2008 PMID： 18767961 DOI： 10.1146/annurev.genom.9.081307.164319

Source DB: PubMed Journal: Annu Rev Genomics Hum Genet ISSN： 1527-8204 Impact factor: 8.929

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Cited

82 in total

1. Users' motivations to purchase direct-to-consumer genome-wide testing: an exploratory study of personal stories.

Authors: Yeyang Su; Heidi C Howard; Pascal Borry
Journal: J Community Genet Date: 2011-05-28

2. Is there a doctor in the house? : The presence of physicians in the direct-to-consumer genetic testing context.

Authors: Heidi Carmen Howard; Pascal Borry
Journal: J Community Genet Date: 2011-09-06

3. Racial and ethnic differences in direct-to-consumer genetic tests awareness in HINTS 2007: sociodemographic and numeracy correlates.

Authors: Aisha T Langford; Ken Resnicow; J Scott Roberts; Brian J Zikmund-Fisher
Journal: J Genet Couns Date: 2012-01-21 Impact factor: 2.537

4. Legislation on direct-to-consumer genetic testing in seven European countries.

Authors: Pascal Borry; Rachel E van Hellemondt; Dominique Sprumont; Camilla Fittipaldi Duarte Jales; Emmanuelle Rial-Sebbag; Tade Matthias Spranger; Liam Curren; Jane Kaye; Herman Nys; Heidi Howard
Journal: Eur J Hum Genet Date: 2012-01-25 Impact factor: 4.246

5. Neither as harmful as feared by critics nor as empowering as promised by providers: risk information offered direct to consumer by personal genomics companies.

Authors: Anders Nordgren
Journal: J Community Genet Date: 2012-04-05

6. Blurring lines. The research activities of direct-to-consumer genetic testing companies raise questions about consumers as research subjects.

Authors: Heidi C Howard; Bartha Maria Knoppers; Pascal Borry
Journal: EMBO Rep Date: 2010-07-16 Impact factor: 8.807

The current landscape for direct-to-consumer genetic testing: legal, ethical, and policy issues.

1. Users' motivations to purchase direct-to-consumer genome-wide testing: an exploratory study of personal stories.

2. Is there a doctor in the house? : The presence of physicians in the direct-to-consumer genetic testing context.

3. Racial and ethnic differences in direct-to-consumer genetic tests awareness in HINTS 2007: sociodemographic and numeracy correlates.

4. Legislation on direct-to-consumer genetic testing in seven European countries.

5. Neither as harmful as feared by critics nor as empowering as promised by providers: risk information offered direct to consumer by personal genomics companies.

6. Blurring lines. The research activities of direct-to-consumer genetic testing companies raise questions about consumers as research subjects.

7. Debating clinical utility.

8. Myths, misconceptions and myopia: searching for clarity in the debate about the regulation of consumer genetics.

9. Health system implications of direct-to-consumer personal genome testing.

Review 10. Practicing pathology in the era of big data and personalized medicine.