Joint Programming Initiative on Antimicrobial Resistance
 

JPIAMR/MRC Recommendations on Diagnostics

A lot of diagnostic equipment has been developed but not much of it actually makes it to the market. On 11 May 2015 in London, the Medical Research Centre UK on behalf of JPIAMR, hosted the workshop ‘Identifying the Pathway to Diagnostic Development’ to look at the route from bench to market of diagnostic development. With both the European Commission and President Obama awarding prizes in the millions for developing diagnostic equipment, which can detect antibiotic resistance, this topic is high on the agenda. The money is there, but the route for making it happen is not clear. Researchers from a wide range of disciplines, health care providers and professionals, industry, national and international policy makers and legislators have been invited to define and agree on a best practice process.

Rosanna Peeling from the London School of Hygiene and Tropical Medicine talking about 'Good Drugs for Bad Bugs' at the JPIAMR Diagnostics Workshop.
Rosanna Peeling from the London School of Hygiene and Tropical Medicine talking about ‘Good Drugs for Bad Bugs’ at the JPIAMR Diagnostics Workshop.

From the discussions emerged four themes where an EU wide solution to achieve better AMR diagnostics could be envisaged.

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1. Regulation

The workshop discussed the divergence between the US and EU regulatory systems as a barrier to diagnostic development. Any opportunity to converge on some issues was supported.

There is a need to:

  • Foster talks between US and EU regulators e.g. sponsored meeting
  • Start to develop an EU wide network of diagnostic development centres e.g. building on infrastructures work, identify key centres, identify standards, capabilities etc.

Develop better links between regulatory science and methodology development e.g. sandpits, workshop

2. Adoption and implementation

Increased and improved advocacy of diagnostic is needed to reassure purchasers that buying the test will improve outcomes. One way to do this may be to provide some funding for key centres across EU to provide evidence of real use of a diagnostic. Purchasers and suppliers will then need to work together with clinicians and vets to demonstrate how investing in such tests will benefit treatment and the full economic impact.

There is a need to:

  • Encourage better engagement with purchasers
  • Develop better mechanisms for advocacy across Europe

3. Resources and sharing

Much better sample and data sharing platforms are needed to ensure better access to information. There also needs for increased linkage with clinical, veterinary and environmental data. This is not unique to AMR and there may already be solutions available that were not being used fully by the bacterial diagnostic community.

There is a need to:

  • Identify existing biobanks across EU and opportunities to network
  • Develop a centralised biobank of samples that is fully accessible across the EU
  • Sponsor specific working groups to establish how data can be better shared
  • Sponsor specific working groups to determine what exactly is needed to be collected and how
  • Workshop or specific working groups on “lessons learned in biobanking” from other functioning biobanks in the EU

4. Connections

The key to accelerating development and use of new diagnostics is better communications and collaboration between a very diverse set of stakeholders.

There is a need to:

  • Foster/sponsor multidisciplinary meetings on specific key issues, keeping them relatively small and focused.