Reassembling The Cancer Clinic: Genomics, ‘Actionability' and Emerging Diagnostic Configurations

In social studies of diagnosis, genomic approaches have often been conflated with risk-based genetic testing and discussed in the context of expectations about how they will transform healthy individuals into at-risk patients. The development of 'high-throughput technologies' in oncology, in particular of clinical sequencing programs, highlights a different side of genomic diagnosis in action, one that is focused on creating new plans of clinical action for cancer patients, rather than computing statistical risks for asymptomatic patients. The paper will analyze how genetic results in cancer diagnosis are made 'actionable', and in particular how the introduction of sequencing technologies has led to new systems of classifications and new venues for deliberating on diagnostic actionability. The implementation of the new genomic diagnostic platforms mobilizes clinical research consortia, regulatory agencies, biotech companies and patient advocacy groups, and requires more than the mobilization of existing structures and arrangements. The 'data deluge' produced by high-throughput technologies necessitates the development of new statistical tools, the establishment of standardized registries and databanks to ensure their reliability, and a redefinition of the biomedical division of labor as manifested by the emergence of new lines of work and shifts in the traditional interfaces between clinicians, biologists, pathologists and patients. They have also led to the establishment of a public genetic diagnostic infrastructure as exemplified by the Stratified Medicine Initiative in the UK or the Molecular Testing Platforms in France. In this paper we examine recent developments in this rapidly changing field, focusing on the tension between clinical research and routine services, and between qualitative and semi-quantitative diagnostic judgments, which in turn refer to different modalities of regulation and objectification of clinical practices.