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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. 1st Gap in Translation. 2nd Gap in Translation. Capacity and Resource.

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Point of Care Testing for Personalised Medicine and Health

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  1. 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

  2. Background to the DECs 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)

  3. Background to the DECs • Facilitate the generation of evidence on: • clinical validity • clinical utility • cost effectiveness • care pathway benefits …of in vitro diagnostic tests (IVDs) – excludes imaging 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) CATALYSE, COLLABORATE, INNOVATE METHODOLOGY

  4. Leeds DEC: Scope & Skills NIHR Biomarkers, BRU & HTC; CRUK / YCR Centre & Programmes Musculoskeletal Colorectal Cancer Urology Liver Core Multi-Disciplinary Diagnostic Research Skills -Health Economics Leeds Institute of Health Sciences -Clinical Informatics MRC Biomedical Informatics Centre -Biobanking Clinical & Biomedical Proteomics Group -Public Involvement Musculoskeletal BRU & LIHS -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 Diagnostics; Prognostics; Monitoring; and Precision Medicine

  5. Personalised Medicine – Opportunity and challenges

  6. Personalised Medicine – Opportunity and challenges

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

  8. 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

  9. 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.

  10. Technology Accelerator

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

  12. 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:

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

  14. 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

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