AMR Diagnostics in the Lime Light

Oct 23rd, 2015

On 23 October 2015, Jim O’Neill, economist appointed by David Cameron, released the fourth report published by the Review on Antimicrobial Resistance ‘Rapid diagnostics: treating patients with infections better and more sustainably’. The Joint Programming Initiative on Antimicrobial Resistance (JPIAMR) welcomes this report which highlights the area of diagnostics use and development to reduce antimicrobial resistance. Research mapping carried out within the initiative has demonstrated that this field is underfunded. Only 11% of competitive national AMR funding goes towards research projects on diagnostics and only 10% of European funding. There is a clear need for more resources.

According to O’Neill, around two thirds of the total antibiotic prescriptions in the US in one year are needlessly given to adults. These prescriptions were likely to have been ineffective in tackling the patient’s particular complaint, and they would have also each have contributed to worsening resistance, in the context of both the individual patients and wider society.
With better diagnostics hospitals will be able to diagnose patients much more quickly. This will have many benefits to both them and their patients.

“To develop better and faster diagnostic tools, we need research. We have to collaborate across national and topical borders to prevent duplication of results and to maximise on resources. Developing private-public partnership will also play a big part. These are the cornerstones of JPIAMR,” said Mats Ulfendahl, Chair of JPIAMR’s Management Board.

The Review on Antimicrobial Resistance report considers the role that rapid diagnostics can play in improving how we use antimicrobials to treat infections better, slow the rise of drug-resistance by reducing the over-use and misuse of medicines, in particular antibiotics, and ultimately change much of our approach to treating bacterial infections by allowing the advent of more targeted and precise therapies.

O’Neill recommends that we need:
• Rapid diagnostics within 5 years in pharmacies, primary care and hospital settings across the globe,
• To focus development of the right diagnostics,
• More grant funding to companies investing in early stage and translational research and;
• To support the building of hard evidence to show that diagnostics work: including clinical, operational and financial evidence.

Dedicated to the One Health approach, JPIAMR and MRC organised a workshop in London on 11 May 2015 which resulted in key recommendations in the areas of regulation, adoption and implementation, resources and sharing and connections in relation to diagnostics. The recommendations included starting up an EU wide network for diagnostic development centres, developing better mechanism for advocacy, centralising biobanks and sponsoring multi-disciplinary activities including research. This has resulted in JPIAMR funding a call for Research Networks within the field of Diagnostics in 2016.

“We need to support research in the area [of diagnostics] to develop the proper tools and change the policy to support the uptake of diagnostics by prescribers as well as change the behaviour of prescribers,” said Arjon Van Hengel, Scientific Officer for Research Funding and Research Policy in the Area of AMR, European Commission, during a podcast interview with JPIAMR.

More information:

Podcasts

Arjon Van Hengel, Scientific Officer for Research Funding and Research Policy in the Area of AMR, European Commission
Why do we need to be able to better diagnose disease to reduce antimicrobial resistance? Arjon Van Hengel explains.


Jorge Villacian, Chief Medical Officers at Janssen Diagnostics
Jorge Villacian shares the success story of how better diagnostics turned the tide for HIV sufferers and explains why diagnostics development in the field of antibacterial resistance is still lagging behind.

Key recommendations from the JPIAMR/MRC Diagnostics Workshop

1. Regulation
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
There is a need to:

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

3. Resources and sharing
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
There is a need to:

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

Read the full report here

Top lines from the report ‘Rapid diagnostics: treating patients with infections better and more sustainably’

  • Within 5 years we need rapid diagnostics in pharmacies, primary care and hospital settings across the globe to get the right drugs to the right patients and combat antimicrobial resistance (AMR) by improving the way we prescribe and use antibiotics.
  • To focus development of the right diagnostics, we need Target Product Profiles (TPPs) for specific areas of high clinical need to combat AMR, combined with advanced market commitments to give more certainty to developers that there will be a market for diagnostic devices that serve a critical need.
  • More grant funding should be available to companies investing in early stage and translational research. A global innovation fund that operates across disciplines or across borders could play a key role. This would provide a significant boost to innovation and help companies take early innovation towards the mid and late stages of development.
  • We need to support the building of hard evidence to show that diagnostics work: including clinical, operational and financial evidence. We particularly need more evidence of the efficacy and cost-effectiveness of diagnostics in the clinical setting, and should provide public support for clinical trials for diagnostics that serve a critical need.