Document Detail

Regulating diagnosis in post-genomic medicine: Re-aligning clinical judgment?
MedLine Citation:
PMID:  21664021     Owner:  NLM     Status:  Publisher    
In recent years, genomic technologies have entered oncology. In particular, so-called tumor signatures are now commercially available for diagnosing breast cancer. These new diagnostic tools have expanded the content and meaning of diagnosis, by adding a distinctive prognostic (will the disease recur?) and predictive (how will the disease react to treatment?) dimension to this activity, and modifying the relations between diagnosis and therapy. In particular, they raise the issue of the locus of clinical judgment and clinical decision-making insofar as they involve a re-alignment of the biological and clinical components of medical activities. Using as a case study a debate over the regulation of tests for genomic signatures by the US FDA, this paper examines how the actors problematize the issues related to the introduction of molecular diagnostics into clinical settings.
Pascale Bourret; Peter Keating; Alberto Cambrosio
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-5-20
Journal Detail:
Title:  Social science & medicine (1982)     Volume:  -     ISSN:  1873-5347     ISO Abbreviation:  -     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-6-13     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8303205     Medline TA:  Soc Sci Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 Elsevier Ltd. All rights reserved.
Aix-Marseille Université, and UMR 912-SE4S, Institut Paoli-Calmettes, 232 Boulevard Sainte Marguerite, 13273 Marseille Cedex 9, France.
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