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Expert guidance on target product profile development for AMR diagnostic tests
Till T Bachmann1, Konstantinos Mitsakakis2,3, John P Hays4
1Center for Inflammation Research, University of Edinburgh, Edinburgh, UK till.bachmann@ed.ac.uk.
BMJ Global Health
|December 19, 2023
Summary
Developing new antimicrobial resistance (AMR) diagnostics requires understanding how target product profile (TPP) characteristics influence each other. This guidance helps prioritize features for more efficient development of vital AMR diagnostic tests.
Area of Science:
- Medical Diagnostics
- Infectious Disease Research
- Public Health
Background:
- Antimicrobial resistance (AMR) poses a significant global health threat, projected to cause 10 million deaths annually by 2030.
- A critical gap exists between the demand for AMR diagnostics and their actual development and implementation.
- Target Product Profiles (TPPs) guide the development of AMR diagnostic tests, but their effectiveness can be enhanced.
Purpose of the Study:
- To extend existing AMR-related TPPs by incorporating interdependencies between key development characteristics.
- To identify and map interdependencies among 46 characteristics across six main categories of TPPs.
- To provide insights for stakeholders on prioritizing TPP characteristics for efficient AMR diagnostic development.
Main Methods:
- A multisectoral working group of 51 international experts from industry, academia, and healthcare was convened.
- 46 characteristics were identified and categorized into six main areas: Intended Use, Diagnostic Question, Test Description, Assay Protocol, Performance, and Commercial.
- Interdependencies between these characteristics were mapped to reveal their influence on each other.
Main Results:
- The study identified and mapped interdependencies among 46 key characteristics crucial for AMR diagnostic development.
- It was recognized that achieving all TPP recommendations simultaneously may be infeasible for developers.
- Guidance is provided on how prioritizing specific TPP characteristics impacts others during the diagnostic development process.
Conclusions:
- Understanding the interdependencies within TPPs is essential for optimizing AMR diagnostic development.
- Prioritization of specific TPP characteristics can lead to more efficient development pathways.
- This work offers guidance to stakeholders for more effective development of AMR diagnostics, bridging the gap between need and implementation.
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