Point of Care Testing for Personalised Medicine and Health Diagnostic Evidence Co-operative Leeds Point of Care Testing for Personalised Medicine and Health Michael Messenger A partnership between the NHS, patients, academia, industry and charities

Background to the DECs Capacity and Resource Translational Continuum 1st Gap in Translation 2nd Gap in Translation Capacity and Resource Biomedical Research New IVD Development & Market Approval Clinical Practice & Adoption Translational Continuum (adapted from www.cihr-irsc.gc.ca)

CATALYSE, COLLABORATE, INNOVATE METHODOLOGY Background to the DECs 1st Gap in Translation DECs Capacity and Resource Biomedical Research New IVD Development & Market Approval Clinical Practice & Adoption Translational Continuum (adapted from www.cihr-irsc.gc.ca) Facilitate the generation of evidence on: clinical validity clinical utility cost effectiveness care pathway benefits …of in vitro diagnostic tests (IVDs) – excludes imaging CATALYSE, COLLABORATE, INNOVATE METHODOLOGY

Leeds DEC: Scope & Skills NIHR Biomarkers, BRU & HTC; CRUK / YCR Centre & Programmes Urology Liver Musculoskeletal Colorectal Cancer Core Multi-Disciplinary Diagnostic Research Skills -Assay Development & Validation Clinical & Biomedical Proteomics Group -Clinical Biochemistry LTHT pathology -Study/Trial Design Leeds CTRU -Quality Assurance CTRU & UKNEQAS Delivering Research in Primary and Secondary Care -Health Economics Leeds Institute of Health Sciences -Clinical Informatics MRC Biomedical Informatics Centre -Biobanking Clinical & Biomedical Proteomics Group -Public Involvement Musculoskeletal BRU & LIHS Diagnostics; Prognostics; Monitoring; and Precision Medicine

Personalised Medicine – Opportunity and challenges

Personalised Medicine – Opportunity and challenges

Personalised Medicine and Health Hospital admission Recovery Late side-effects Chronic disease relapse Death Hospital discharge Acute disease diagnosed Disease response Treatment initiation Prediction & Prevention Early Diagnosis Treatment benefit / response Monitoring Symptomatic Disease Asymptomatic Disease Free Disease Screening Molecular Phenotyping Prognosis Shift towards maintaining health and preventing disease

A few issues.. Diagnostic testing strategies are complex interventions requiring multidisciplinary cross-sector expertise. Poor understanding of end user evidence requirements - focus on test accuracy, not patient outcomes, cost-effectiveness or system benefits. Inadequate consideration of factors affecting measurement (metrology)- e.g. biological, pre-analytical and analytical variability Poor study and trial design, inadequate reporting practices and preferential publication of positive results    Inability to associate cost savings in one area of the healthcare system, due to relatively minor cost outlay elsewhere

When is point of care testing (POCT) needed? POCT often provides quicker test results, but usually with greater uncertainty (accuracy-1) and cost. If the time to result is critical, then the benefits may offset any greater diagnostic uncertainty and cost. Determining which approach to use is often hard without a model.

Technology Accelerator

Case Study Diagnostics for Reduction of Antibiotic Misuse Prof Christoph Wälti & Prof Mark Wilcox

Rapid tests for Infection Lack of instant and accurate diagnostic tools for infectious diseases leads to inappropriate antimicrobial prescribing Increased antimicrobial prescribing is associated with increased antimicrobial resistance (AMR) Collaboration with 3 UK SMEs Develop and evaluate a rapid point of care test £3.9 Million from Medical Research Council Brings together Leeds commercial IP and cross-faculty expertise in: Nano Biosensing Active Capture Molecules (Adherons) Microfluidics Clinical Microbiology Diagnostic Test Evaluation

Wednesday 19th October, Queens Hotel, Leeds https://www.eventbrite.co.uk/e/the-1st-leeds-precision-oncology-symposium-tickets-26373622214

Acknowledgements All the DEC Leeds collaborators and partners The Diagnostic Evidence Co-operative Leeds is funded by the National Institute for Health Research and is a partnership between the Leeds Teaching Hospitals Trust and the Universities of Alberta, Edinburgh, Leeds, Oxford, Southampton and University College London. E-mail: NIHRDEC@leeds.ac.uk Web: www.leeds.dec.nihr.ac.uk Twitter: @DEC_Leeds