Responsible healthcare innovation: anticipatory governance of nanodiagnostics for theranostics medicine

Abstract

Theranostics signals the integrated application of molecular diagnostics, therapeutic treatment and patient response monitoring. Such integration has hitherto neglected another crucial dimension: coproduction of theranostic scientific knowledge, novel technological development and broader sociopolitical systems whose boundaries are highly porous. Nanodiagnostics applications to theranostics are one of the most contested and potentially volatile postgenomics innovation trajectories as they build on past and current tensions and promises surrounding both nanotechnology and personalized medicine. Recent science policy research suggests that beneficial outcomes of innovations do not simply flow from the generation of scientific knowledge and technological capability in a linear or automatic fashion. Thus, attempts to offset public concerns about controversial emerging technologies by expert risk assurances can be unproductive. Anticipation provides a more robust basis for governance that supports genuine healthcare progress. This article presents a synthesis of novel policy approaches that directly inform theranostics medicine and the future(s) of postgenomics healthcare.

Keywords::

• anticipatory governance
• engagement
• ethics
• innovation policy
• nanodiagnostics
• nanotechnology
• responsible innovation
• risk and uncertainty
• sociotechnical integration
• theranostics medicine

Financial & competing interests disclosure

This material is based upon work supported by the National Science Foundation under grant numbers 0849101, 0738203, 0937591 and MCB-1243082. E Fisher is assistant director for international activities at the Center for Nanotechnology in Society at Arizona State University (NSF 0937591), which pursues a program of anticipatory governance and he is principal investigator of the Socio–Technical Integration Research (STIR) project (NSF 0849101), which seeks to engage expert practitioners in productive deliberation. M Boenink and S van der Burg lead a project funded by the Centre for Society and the Life Sciences and the Center for Translational Molecular Medicine for a project on ‘Exploring possibilities for patient involvement in translational molecular medicine’. M Boenink also received research grant from the Dutch Organization for Scientific Research (NWO), Program Responsible Innovation, for a research project on ‘Responsible early diagnostics for Alzheimer’s disease’. N Woodbury is a co-founder of HealthTell, which has a financial interest in Immunosignaturing as it has an exclusive license. He is also either principal investigator or co-principal investigator of three grants to Arizona State University that involve the development of immunosignaturing or the technologies that support it (NSF Inspire grant: MCB-1243082, DTRA Grant: HDTRA1-11-1-0010 and DTRA contract: HDTRA1-12-C-0058). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.