Diagnostic evidence cooperatives: bridging the valley of death in diagnostics development

BACKGROUND: Diagnostic tests’ impact on patient outcomes and health processes is potentially large, and proper evaluations before widespread adoption are warranted. Such evaluations are challenged by the fact that tests can have multiple purposes, in different clinical pathways, with different roles. BODY: The National Institute for Health Research (NIHR) established four Diagnostic Evidence Cooperatives (DEC) in 2013, across England. The aim of these DECs was to facilitate the development and evaluation of clinically relevant in vitro diagnostics, by offering methodological expertise and access to real-life settings for evaluations in patients. In this commentary, we discuss our experience over the past 4 years. CONCLUSION: The interaction of industry, researchers, and clinicians has proven to be very worthwhile.