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

The IDx project seeks to contribute to a greater understanding of the barriers to uptake of AMR diagnostics in different clinical settings. Understanding these barriers will support removing obstacles to increased use of diagnostics for surveillance and prescription.

The IDx project is a collaboration between Uppsala University and the Karolinska Institute, Sweden; the industry association BEAM Alliance, France, Université de Laval, Canada, and the University of Cape Town, South Africa to address these issues. The project work has also consulted with international experts and policymakers in the field of diagnostics on challenges to implementation. In so doing, the research team has studied regulations, reimbursements systems, companies developing diagnostics technologies, and hospitals using, or not using, them to identify challenges to the uptake of new diagnostic technologies.

The findings from the project show, for example, how in high-income clinical settings, barriers concern government regulation of diagnostics development, procurement, and use, along with the private and public financing available for diagnostics in different stages of commercialization. In low-income health care settings, these issues are important yet overshadowed by the lack of resources and infrastructure for the use of diagnostics. As have the importance of governments to have a long-term prioritization of diagnostic capability in order to be able to detect and monitor AMR. In addition, the importance and particular benefits of collaborations between developers of diagnostics, developers of antibiotics, and the hospitals using both in combiation have been analyzed. Important findings moreover revolve around how the new regulation may hinder innovation that normally derives from the creation of lab-developed tests. Lastly, this work identified several hospital-centered barriers to uptake, such as the perceived complexity of new diagnostics, lack of trust in test results, and uncertainty about impact on user and local organization.

The most important impact of our project is the one caused by the spreading of this much needed knowledge to both companies developing AMR diagnostics technologies, to hospitals using them, and to public policy makers and regulators who might be able to support the spread of these new AMR diagnostics technologies.