Moving forward infection diagnostics event: Optimising evaluations

The Antimicrobial resistance diagnostics team at the office of the Chief Scientific Officer NHS England hosted its third event in the successful Moving Forwards Infection Diagnostics series, titled “Optimising Evaluations”.

It was jointly hosted with NIHR Leeds Biomedical Research Centre (BRC) and sponsored by British In Vitro Diagnostics Association (BIVDA) sponsor of the event. The Association of British Healthcare Industry (ABHI). The event provided a forum for leading industry companies, academics, policy makers and clinical leaders to collaborate closely on improving infection diagnostics, by optimising the evaluations required to support them.

The event was chaired by Dr Kerrie Davies, Senior Scientific Advisor at the office of the Chief Scientific Office, and Dr Jane Freeman, Co-Deputy Lead for AMR and Infection at Leeds NIHR BRC.

Connie Longmate, Policy Lead for the Department of Health and Social Care set out the UK policy landscape and strategy, the progress made so far in the 2019-24 NAP and the underlying the commitment by ministers to the AMR agenda. Connie also outlined key research priorities and themes with an emphasis on diagnostics in infection management for the new NAP.

Patients were at the heart of the event, led by Melissa Mead MBE of UK Sepsis Trust, who bravely shared her own experience of losing her child to from sepsis due to delayed diagnosis. This story emphasised the importance of getting diagnosis right for patients and helped steer focussed discussions during the event to meet the objectives for the day.

Delegates heard from expert speakers who covered the different types of evaluations required for Infection diagnostics, including regulatory authorisations, analytical validation, real world evidence, and health economic and behavioural analysis.

This collaborative event included panel discussions including a dedicated industry panel session on how industry navigates the evaluations process, chaired by Angela Douglas, MBE, President of BIVDA. Delegates discussed minimising repetitive evaluations and maximising data sharing in interactive breakout sessions.

Professor Mike Messenger Head of BIVDA Regulation, speaker and industry attendee, said: “There was general agreement that regulation and evidence generation are challenges, but are not insurmountable with good planning, proper budgeting, early stakeholder engagement and effective collaboration between private and public sectors. However, even when innovators get all of this right it does not lead to timely use or reimbursement at the moment. We must find a way of quickly releasing funding and implementing AMR Diagnostics once they have been properly developed, authorised and evaluated!”.

Dr Yoann Personne, industry attendee and panel guest speaker, said: “Repeated pilot studies for new technology are costly and time consuming, so this meeting was a great opportunity to explore better evaluation processes. It’s exciting to collaborate across industry, research, and the NHS to identify best practices and accelerate patients access to new diagnostics“.

Julie Hart, Senior Research Fellow, School of Pharmacy, University of Reading and IVD Expert Advisory Group member, MHRA said: “We are currently commercialising the output of our research, as such the Leeds BRC meeting was superbly timed for informing our thinking and helped us identify a few red flags in our current approaches. As a result we have made some strategic decisions in critical aspects of our project which will ultimately have downstream impact as we move towards IVDR”.

The outputs are being developed and will be shared shortly. The next event is planned for January 2025, and will focus on adoption, implementation of diagnostics, and funding.

Amanda Winter presenting