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

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.