The Consultant's intermediary role in the regulation of molecular diagnostics in the US.

Molecular diagnostics are fast becoming a big business, with the promise of personalized medicine fueling the growth of "blockbuster" tests with high expectations for health system impact and commercial success. We investigate the polycentric regulatory regime for molecular diagnostics in the US, drawing attention to the prominent role of coverage and reimbursement systems in setting regulatory standards for this industry. We hone in on the private consultants who assist molecular diagnostics companies to gain broad clinical uptake of their products. Through a web-based search of consulting companies, analysis of their online materials, and 13 qualitative interviews with consultants, we describe the role of these actors in the coverage and reimbursement of novel diagnostics and highlight the production of evidence as a critical part of the process. We argue that consultants operate as regulatory intermediaries, helping to develop the evidentiary standards for payment decisions that ultimately benefit their clients, the manufacturers. We suggest that public policy discussions over how best to realize the promise of personalized medicine should be re-oriented to consider whose interests are represented in the regulatory regime governing access to these technologies.