1. 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

2. 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

3. 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
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

4. 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

5. Personalised Medicine – Opportunity and challenges

6. Personalised Medicine – Opportunity and challenges

7. 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

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:
Nano Biosensing
Active Capture Molecules
(Adherons)
Microfluidics
Clinical Microbiology
Diagnostic Test Evaluation

13. Wednesday 19th October, Queens Hotel, Leeds

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.
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