Bench, Bedside, Business, and Beyond: innovative solutions for AMR diagnostics

Lead Research Organisation: Imperial College London
Department Name: School of Public Health

Abstract

The network, B2B2B AMRDx, brings together a diverse group of researchers from universities (bench), hospitals (bedside), for-profits (business), governments and nonprofits (beyond), to tackle some of these challenges. We have expertise in human, animal, and environmental AMR, and come from 20 different countries. The networks goals are as follows.

First, the network creates a comprehensive online AMR Diagnostics Developer Directory (ADDD) to facilitate exchange of ideas in the field. Second, the network extends the JPIAMR Seq4AMR Virtual Benchmarking Platform (VBP) to allow diagnostics developers to systematically evaluate their diagnostics on a collection of high-quality genotypes (genomic data) and phenotypes (antimicrobial resistance data) and identify their strengths and weaknesses. Third, the network identifies new policy directions that can support diagnostics development and adoption by accounting for the public health benefits of using AMR diagnostics. These developments will help AMR diagnostics cross the "valley of death" and help patients.

Expected outcomes:

An open, curated online AMR diagnostics developer directory (ADDD), building on AMR Insights' Technology Pages.
A workshop to develop the standards for genotypes, phenotypes, and metadata, as well as the accompanying bacterial isolates for the VBP, building on previous achievements of the Seq4AMR network (Raphenya et al, 2022)
A systematic approach for the management, selection and curation of gold standard NGS data, phenotype data, and metadata, as well as the corresponding bacterial isolates for the VBP.
Communication, dissemination and roadmap open-access publication describing the VBP contents, its format, and the benchmark set selection protocol. Possible journals: Microbial Genomics or similar.
A workshop to develop a proposal for a regulatory pathway to allow AMR diagnostics developers to benefit from incentives based on the public health benefits of their products.
An open-access roadmap publication describing the proposed policy.

Technical Summary

As antimicrobial resistance (AMR) becomes more widespread, efforts to extend the usability of current antimicrobial agents by developing and applying diagnostics to identify the appropriate narrow-spectrum antimicrobial for each infection take centre stage. However, diagnostic developers currently suffer from late-stage attrition, creating a "valley of death" that prevents diagnostic tools from reaching patients.

The B2B2B AMRDx network is a cross-disciplinary, geographically diverse and gender-balanced group of partners from universities (bench), hospitals (bedside), for-profits (business), governments and nonprofits (beyond), with expertise in all One Health settings: human, animal, and environmental AMR. Improved communications between stakeholders in multiple sectors, an objective of the WHO's Oslo Medicines Initiative, benefits the development of rapid, reliable AMR diagnostics. We focus on 3 objectives to address the challenges faced by AMR diagnostics developers.

Objective 1 expands an open, self-curated, comprehensive online AMR Diagnostics Developer Directory (ADDD) to facilitate exchange of ideas and create synergies in the field. Objective 2 further develops the JPIAMR Seq4AMR Virtual Benchmarking Platform (VBP) for genotype-to-phenotype microbial benchmarking studies that will include gold standard whole genome sequences, phenotypes, and metadata, as well as accompanying microbial isolates. Objective 3 defines policy Pathways to AMR-specific Incentives for Developing Diagnostics (PAIDD), maximising public health benefits from the use of AMR diagnostics.

Publications

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