Regulating diagnosis in post-genomic medicine

Re-aligning clinical judgment

Bibliographic Data

ID4596028
AuthorsPascale Bourret (0000-0001-7294-7461, Aix-Marseille Université), P Keating (0000-0001-7236-9761, Université du Québec à Montréal), Alberto Cambrosio (0000-0001-5922-0137, McGill University)
Year2011
Volume73
Issue6
Pages816-824
Publication date2011-09-01
Peer ReviewedYes
Open AccessYes
TypeARTICLE
VenueSocial Science & Medicine (JOURNAL)
Journal identifiersISSN: 0277-9536 • E-ISSN: 1873-5347
PublisherElsevier BV (PUBLISHER)
DOI10.1016/j.socscimed.2011.04.022
PMID21664021
OpenAlexW2082665009
LanguageIT
Citations received36
References cited25

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

Bioinformatics · Biology · Breast cancer · Cancer · Clinical Practice · Computational biology · Disease · Family medicine · Genomic medicine · Intensive care medicine · Meaning (existential · Pathology · Personalized medicine · Precision medicine · Psychotherapist · Biomedical Ethics and Regulation · BRCA gene mutations in cancer · Ethics in Clinical Research · Medicine · Psychology · Internal Medicine

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