Literature DB >> 20703288

Which way for genetic-test regulation? Assign regulation appropriate to the level of risk.

Gail Javitt1.   

Abstract

Mesh:

Year:  2010        PMID: 20703288     DOI: 10.1038/466817a

Source DB:  PubMed          Journal:  Nature        ISSN: 0028-0836            Impact factor:   49.962


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  5 in total

1.  Direct-to-consumer genetic tests, government oversight, and the First Amendment: what the government can (and can't) do to protect the public's health.

Authors:  Gail H Javitt; Erica Stanley; Kathy Hudson
Journal:  Oklahoma Law Rev       Date:  2004

2.  A critical appraisal of the scientific basis of commercial genomic profiles used to assess health risks and personalize health interventions.

Authors:  A Cecile J W Janssens; Marta Gwinn; Linda A Bradley; Ben A Oostra; Cornelia M van Duijn; Muin J Khoury
Journal:  Am J Hum Genet       Date:  2008-03       Impact factor: 11.025

3.  Genomic profiles for disease risk: predictive or premature?

Authors:  Kenneth Offit
Journal:  JAMA       Date:  2008-03-19       Impact factor: 56.272

4.  Evaluation of risk prediction updates from commercial genome-wide scans.

Authors:  Raluca Mihaescu; Mandy van Hoek; Eric J G Sijbrands; André G Uitterlinden; Jacqueline C M Witteman; Albert Hofman; Cornelia M van Duijn; A Cecile J W Janssens
Journal:  Genet Med       Date:  2009-08       Impact factor: 8.822

5.  Informational content, literacy demands, and usability of websites offering health-related genetic tests directly to consumers.

Authors:  Christina R Lachance; Lori A H Erby; Beth M Ford; Vincent C Allen; Kimberly A Kaphingst
Journal:  Genet Med       Date:  2010-05       Impact factor: 8.822

  5 in total
  11 in total

1.  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

2.  Understanding FDA regulation of DTC genetic tests within the context of administrative law.

Authors:  Jennifer K Wagner
Journal:  Am J Hum Genet       Date:  2010-10-08       Impact factor: 11.025

3.  Direct-to-consumer testing: if consumers are not anxious, why are policymakers?

Authors:  Timothy Caulfield
Journal:  Hum Genet       Date:  2011-04-11       Impact factor: 4.132

Review 4.  Direct-to-consumer personalized genomic testing.

Authors:  Cinnamon S Bloss; Burcu F Darst; Eric J Topol; Nicholas J Schork
Journal:  Hum Mol Genet       Date:  2011-08-09       Impact factor: 6.150

5.  Bring on the biomarkers.

Authors:  George Poste
Journal:  Nature       Date:  2011-01-13       Impact factor: 49.962

6.  Ethical and Professional Challenges Encountered by Laboratory Genetic Counselors.

Authors:  Daniel Groepper; Patricia McCarthy Veach; Bonnie S LeRoy; Matthew Bower
Journal:  J Genet Couns       Date:  2014-11-16       Impact factor: 2.537

7.  Genetic testing for aldehyde dehydrogenase 2 deficiency in young adults.

Authors:  C S Hendershot
Journal:  Pharmacogenomics J       Date:  2011-02-15       Impact factor: 3.550

8.  FDA's Proposed Guidance for Laboratory Developed Tests: How Should Regulators Balance the Risks and Promise of Innovation in Clinical Genetics?

Authors:  Michelle Bayefsky; Benjamin E Berkman
Journal:  FDLIs Food Drug Policy Forum       Date:  2015-02-25

9.  Field of genes: an investigation of sports-related genetic testing.

Authors:  Jennifer K Wagner; Charmaine D Royal
Journal:  J Pers Med       Date:  2012-09-12

Review 10.  Genetic data and electronic health records: a discussion of ethical, logistical and technological considerations.

Authors:  Kimberly Shoenbill; Norman Fost; Umberto Tachinardi; Eneida A Mendonca
Journal:  J Am Med Inform Assoc       Date:  2013-06-14       Impact factor: 4.497

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