IDx: An exploration of regulatory, corporate, relational, and technical barriers to uptake of diagnostics in the fight against AMR


Research Project: 2020-04-01 - 2023-12-31
Total sum awarded: €648 800

Greater availability of fast and accurate diagnostics for infections would greatly reduce the over-prescription of antibiotics and slow the growth of antibiotic resistance which limits treatment options. It would also help prescribe the right drug at the right time, thus reducing suffering and increasing survival. However, despite advances in technology, few useful diagnostics for bacterial infections have come to market and we are seeing a downward trend in innovation. This study proposes to identify the key barriers that remain once a new diagnostic has been developed, looking at recent technological advances that ultimately failed to be authorized, adopted, or able to change prescribing. It will also look at technologies that have helped in the fight against antimicrobial resistance. Are there any features or particularities that seem to have improved their chance of success? Lessons from the failures and few successes will be used to assess chances for products in the pipeline, examining how regulation, reimbursement, technology transfer, and organizational characteristics might be improved to make them succeed within the clinical setting. The work will focus on each of these themes in developed world settings but also use them as a lens (in addition to a technical lens) to examine determinants of uptake in rural parts of South Africa, which are to some extent a proxy for LMIC.

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  • Olof Lindahl, Uppsala University, Sweden (Coordinator)
  • Marc Mendelson, University of Cape Town, South Africa (Partner)
  • Eve Dubé, Université Laval, Canada (Partner)
  • Volkan Özenci, Karolinska Institutet, Sweden (Partner)
  • Florence Séjourné, BEAM Alliance, France (Partner)

Better and faster diagnostics are needed to know whether or not a patient needs antibiotic treatment. With more targeted treatment we would see better health outcomes and slower growth of antibiotic resistance. The diagnostics market has seen a lot of innovation in recent years, yet we don’t see many of these new technologies making it to hospitals and health centres in poor or rich parts of the world. This study examines the challenges faced after a diagnostic is developed – from the regulatory hurdles to distribution, to reimbursement requirements, to uptake and sustained procurement decisions amongst procurers, laboratories, and clinicians. With a more nuanced understanding of the post-development environment it is hoped that we can get accurate, reliable, and rapid diagnostics into the clinical setting to improve prescribing of antibiotics and improve surveillance of antibiotic resistance.