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Regulating diagnosis in post-genomic medicine: Re-aligning clinical judgment?

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  • Bourret, Pascale
  • Keating, Peter
  • Cambrosio, Alberto

Abstract

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.

Suggested Citation

  • Bourret, Pascale & Keating, Peter & Cambrosio, Alberto, 2011. "Regulating diagnosis in post-genomic medicine: Re-aligning clinical judgment?," Social Science & Medicine, Elsevier, vol. 73(6), pages 816-824, September.
    • Handle: RePEc:eee:socmed:v:73:y:2011:i:6:p:816-824
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    References listed on IDEAS

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    1. Knaapen, Loes & Cazeneuve, Hervé & Cambrosio, Alberto & Castel, Patrick & Fervers, Beatrice, 2010. "Pragmatic evidence and textual arrangements: A case study of French clinical cancer guidelines," Social Science & Medicine, Elsevier, vol. 71(4), pages 685-692, August.
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    3. Moreira, Tiago, 2005. "Diversity in clinical guidelines: the role of repertoires of evaluation," Social Science & Medicine, Elsevier, vol. 60(9), pages 1975-1985, May.
    4. Cambrosio, Alberto & Keating, Peter & Schlich, Thomas & Weisz, George, 2006. "Regulatory objectivity and the generation and management of evidence in medicine," Social Science & Medicine, Elsevier, vol. 63(1), pages 189-199, July.
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    5. Cambrosio, Alberto & Campbell, Jonah & Keating, Peter & Bourret, Pascale, 2022. "Multi-polar scripts: Techno-regulatory environments and the rise of precision oncology diagnostic tests," Social Science & Medicine, Elsevier, vol. 304(C).
    6. Sturdy, Steve, 2022. "Framing utility: Regulatory reform and genetic tests in the USA, 1989–2000," Social Science & Medicine, Elsevier, vol. 304(C).
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