This document summarizes a workshop on mapping the UK diagnostics landscape. The workshop included sessions on industry views, clinicians' views, the current diagnostics system, how diagnostic pathways can be achieved, and the role of health technology assessment in diagnostics. Speakers discussed topics like the potential for rapid diagnostics in community healthcare, barriers to diagnostic usage, tackling antimicrobial resistance, and how industry is driving greater diagnostic uptake. The goal of the workshop was to evaluate how fit the current diagnostics system is for purpose and identify ways to improve it.

1. Mapping the Diagnostics Landscape
A UKADC Workshop for System
Partners
Supported by

2. Where do you think you sit on
the Diagnostics System?
PRODUCT
ADOPTION?
?
PRODUCT
EVALUATION
2
PRODUCT
DEVELOPMENT

3. The system as its stands
1. Is it fit for purpose?
2. Who does what exactly & why?
3. Is your role as effective as it could be?
4. Do you believe the system works?
5. How do we make it work better?
6. How can I make it work better?
3

4. Keynote-
Lord O`Neill of
Gatley

5. Biological test
should be
mandatory,
should’nt
they?
Phil Howard, Consultant
Antimicrobial Pharmacist, Leeds
Teaching Hospitals
Mark Fielder, Professor of Medical
Microbiology, Kingston University,
London
David Wells, Head of Pathology
Services Consolidation, NHS
Improvement
Dr Elisabeth Adams, MD,
Aquarius Population Health

6. QUESTIONS
DO YOU BELIEVE
THERE IS A ROLE FOR
RAPID DIAGNOSTICS
WITHIN COMMUNITY
HEALTHCARE OR
SHOULD ALL TESTING
REMAIN IN THE LAB?
DO YOU BELIEVE THE
BARRIER TO USAGE OF
RAPID DIAGNOSTICS IS
THE COST?
DO YOU THINK
TACKLING
ANTIMICROBIAL
RESISTANCE CAN BE
ACHIEVED THROUGH
DIAGNOSTICS OR
WOULD YOU INVEST
INTO ALTERNATIVE
METHODS?
IS THE DECISION
MAKING PROCESS FOR
DIAGNOSTIC USAGE
CONFUSING AND
CONVOLUTED? IS IT FIT
FOR PURPOSE?
WHY HAVE THE O' NEIL
REVIEW
RECCOMENDATIONS
FAILED TO BE
IMPLEMENTED? WHO
IS AT FAULT AND HOW
DO WE CHANGE?

7. Mapping the current
landscape and system
for Diagnostics
Session supported by
Dr Sarah Byron,Associate
Director,Diagnostics Assessment
Programme, National Institute for
Health and Care Excellence & Scott
Buckler, Founder, 4 All of Us

8. INDUSTRY VIEWS

9. CLINICIANS VIEWS

10. Mike Wakemen, Pharmacist Consultant
How a diagnostic
pathway can be
achieved

11. Michael Wakeman BSc, MSc MRPharmS
How a diagnostic pathway can be achieved
Mapping the Diagnostics Landscape
A UKADC Workshop for System Partners

12. Initial Pilot Intervention
O A pilot study to investigate the use of Point of
Care C-reactive protein (POC CRP) testing in
community pharmacy to deliver appropriate
interventions in Respiratory Tract Infections
(RTIs)

13. Cough (acute): antimicrobial prescribing
NICE guideline
Published: 7 February 2019
nice.org.uk/guidance/ng120
©

14. 6037
4530
50
Adults
Children/adolescents
Age unknown
more than 40% of study participants were children as from the age of 1 year
439
426
1852
820
200
608
Tonsillopharyngitis (children)
Acute sinusitis (adults)
Acute bronchitis (adults)
Acute bronchitis (children)
Chronic bronchitis
Common Cold
4345 patients in placebo-controlled clinical trials
Kaloba-Extensively Clinically
Investigated
16 14

15. Aims of Study
O Evaluate a CRP test in community pharmacy
O Assess the acceptability of point of care CRP
testing in community pharmacy
O Investigate any reduction in GP appointments
for non- LRTIs.
O Assess impacts upon a subsequent antibiotic
prescribing.
O Deliver a scalable model

16. Supporting Materials
O A brief introduction to CRP for Healthcare professionals
O Cough/Chest Infection Poster A3
O Doctor letter
O Patient Information Sheet
O FAQs
O Patient Questionnaire
O Service Level Agreement
O Symptoms of a cold
O V4 TYI leaflet for community pharmacy

17. Patient pathway

19. Day 3 Follow-up
O Day 3 questions only:
O Were you expecting the test? (yes/no)
O Did the test help your understanding? (yes/no)
O Was it painful? (yes/no)
O Were the results easy to understand? (yes/no)
O Would you have otherwise have visited the GP?
(yes/no)
O Would you have otherwise have visited another
healthcare professional? (yes/no)
O Would you have expected antibiotics? (yes/no)
O Can I call back in 4 days? (yes/no)

20. Day 3 and 7 follow-up
O Day 3 and 7 questions:
O On a scale of 1–5 how would you assess the following symptoms:
O Shortness of breath (likert scale 1–5)
O Wheezing (likert scale 1–5)
O Chest pain (likert scale 1–5)
O Breathing abnormalities (likert scale 1–5)
O Perspiring (likert scale 1–5)
O Headache (likert scale 1–5)
O Myalgia (likert scale 1–5)
O Feeling generally unwell (likert scale 1–5)
O Others (please state)
O Do you have a fever (>38°C)? (yes/no)
O Have you subsequently needed to visit a GP or another
healthcare professional as a result of these symptoms? (yes/no)
O If yes, did you receive an antibiotic prescription? (yes/no)

21. Outcomes

22. Conclusions

23. https://www.pharmaceutical-journal.com/research/research-article/point-of-care-c-reactive-
protein-testing-in-community-pharmacy-to-deliver-appropriate-interventions-in-respiratory-tract-
infections/20204635.article

25. Supporting UK pharmacist study
O Evaluating a point-of-care C-reactive protein test to support antibiotic prescribing decisions in a general practice
pharmaceutical-journal.com/research/research-article/evaluating-a-point-of-care-c-reactive-
protein-test-to-support-antibioticprescribing-decisions-in-a-general-practice/20201688.article

26. Extending the Service
O Engagement of more pharmacies
O Reimbursement model
O Seeking Funding
O Remodelling the proposition

27. Thank You

28. Greg Quinn, Director, Public Policy &
Advocacy UKI,Corporate/Shared Services, BD
How industry are
driving Diagnostic
usage

29. Confidential—For Internal Use Only
Greg Quinn
Industry’s Approach to driving diagnostic usage
2
9

30. • Public policy, solution development and implementation
• Driving best practice through guideline development and implementation at a
patient, regional
• Local and national partnership
• Risk and gain share
• Quicker time to treatment, precision diagnostics leading to gold standard diagnostic and
treatment pathways
• Targeted diagnostics for each patient
• Automation and consolidation
• Improving the speed to delivering best access and outcomes
Industry’s Approach to driving diagnostic usage

31. Lab automation / NHSI / Path cons / workforce
Efficiency
Flexibility
Performance
Reducing labor costs by
increasing capacity with high
throughput integrated
solutions
Large Regional Hub
Evolving standalone solutions
- Automate the most
challenging processes
Integrating Diagnostics with
ID/AST and Imaging applications
– Reduce time to ID and AST
results
Simplifies and standardizes user
workflows for all samples and assays to
reduce workflow complexity
Interconnected molecular and
cytology testing across scalable and
modular platforms supporting
multiple standards and guidelines
Differentiated and Highly Valued
Multiplex assays designed to provide
actionable results & improve clinical
outcomes

32. Microbiology & Molecular
Patient
Management
Performance
Targeted disease
solutions enable
extended coverage and
appropriate diagnostic
utilization- offering
wider portfolio choice
addressing crucial
disease states
Evolving standalone solutions -
Integrate diagnostics with
standalone incubation and imaging
applications-offering modularity
enabling future proofing capabilities as
networks evolve
Integrating Diagnostics with blood culture and
ID/AST connected to Synapsys – focusing on
connectivity linking satellite solutions
Increased flexibility on menu
utilization improves efficiency and
reduces costs while expanding
connectivity
simplifies user interaction
Microbiology
Growth & Detection Molecular
Spoke Hospitals

33. The role of
Health
Technology
Assessment
for Diagnostics
Dr Sarah Byron,Associate
Director,Diagnostics Assessment
Programme, National Institute for
Health and Care Excellence

34. © NICE 2018. All rights reserved. Subject to notice of rights.
NICE Assessment of
Diagnostic Technologies
Sarah Byron
Associate Director, Diagnostics Assessment Programme
Sarah.Byron@nice.org.uk

35. National Institute for Health and Care Excellence
Improves outcomes for people using the NHS and other public
health and social care services.
 Produces evidence-based guidance and guidelines
 Develops quality standards and performance metrics
 Provides a range of information services
• reduce inequalities and variation
• ensure quality and value for money for the NHS

36. Diagnostics Assessment Programme
All types of diagnostic technology:
• Imaging
• Monitors
• IVDs
• Digital
• Combination
36
5 main uses:
• Diagnosis
• Monitoring
• Screening
• Prognostic
• Predictive
All diseases and conditions

37. Value of Diagnostics
System
Benefits
Reduce
length of
stay
Speed up
recovery
Different
staff grade
or type
Reduce
Process
Time
Required
Patient
Benefits
Improve
comp-
liance
Decision
or care
nearer
home
Reduce
unnecessary
interventions
Enhance
dignity
Enable
Self Care
Improve
health
outcome
Reduce
hospital
-isation
Optimise
treatment
choice
Diagnostics Assessment Programme (DAP) examine the VALUE of all
types of diagnostic technologies

38. Evolving role
• Encourage innovation and increase NHS uptake
• Support adoption of cost effective technologies
• Highlight evidence gaps and promote further
research
• Stop inappropriate testing
• Support new clinical pathways
• Encourage equitable access to technologies
38

39. Aim of Assessment
Is the technology clinically effective?
Is it cost effective?
Current NHS
practice
Current NHS
practice
Technology
vs.

40. Population
Technology Diagnostic
and Care
Pathway
Treatment
Diagnosis
Condition
Outcomes
Costs
Scope: Assessment Framework

41. DAP Approach to Diagnostics Challenges
LINKED EVIDENCE MODELLING
Diagnostic
Accuracy
Impact on Treatment
Decisions
Impact on
Outcomes
Utilises existing
evidence for
parts of the care
pathway to
develop models
Can utilise
existing models
(directly or with
modification )
Topic/clinical
expert input into
model structure
and evidence
gaps

42. Process
Public Consultation
Decision
Stakeholder
Perspectives
Independent
Review of evidence
Input from
topic experts
Independent
decision-making
Committee
Recommend
for Routine
Use
Do Not
Recommend for
Routine Use
Recommend
Further
Research

43. Challenges for diagnostics guidance
Complexity and
variation in diagnostic
and care pathways
End to end clinical studies
following patients from
diagnosis through care to
outcomes rarely available
Rapid
product
evolution Lower level of
resources
available in
diagnostic
‘sector’
Alternative
technologies
Real world
implementation
uncertainty
Benefits typically
result indirectly
from treatments

44. Implementation uncertainty
Tests for rapidly identifying bloodstream bacteria and fungi
LightCycler SeptiFast test
MGRADE
SepsiTest IRIDICA BAC BSI assay
62 studies reporting diagnostic accuracy data
41 studies reporting intermediate and clinical outcome data

45. Tests for rapidly identifying bloodstream bacteria and
fungi
LightCycler SeptiFast Test
MGRADE
SepsiTest IRIDICA BAC BSI
Insufficient evidence to recommend routine adoption
Clinical utility
Levels of certainty
needed to change
treatment
Children and
neonates

46. Another diagnostics example……
Procalcitonin testing for diagnosing and monitoring sepsis
stopping antibiotic treatment in
people with confirmed or highly
suspected sepsis in the intensive
care unit
starting and stopping antibiotic
treatment in people with suspected
bacterial infection presenting to the
emergency department
18 RCTs available with end clinical outcome data
No UK based studies

47. Clinically
equivalent to
current
practice but
uncertain
costs
Procalcitonin testing for diagnosing and monitoring sepsis
stopping antibiotic
treatment in people with
confirmed or highly
suspected sepsis in the
intensive care unit
starting and stopping
antibiotic treatment in people
with suspected bacterial
infection presenting to the
emergency department
Research
recommendations
to explore the
impact on
resource use in
the NHS

48. Potential challenges in AMR diagnostics
Treatment tailored to
patients
Silo working
Evidence of impact
Scientific
knowledge of
AMR
Clinical risk
Patient and
clinical
understanding
Value for money
Innovation
Cost of
antibiotics
Funding
Behavioural
change

49. Engaging with NICE
49

50. INNOVATE UK
EMA
NICE
AHSNs
The evolving landscape
Product Development
PRODUCT
ADOPTION?
?
PRODUCT
EVALUATION
Patients and healthcare systems need
access to clinically and cost effective
products as quickly as possible
New initiatives in landscape
(EAMS, PRIME, AAR, Life Sciences Industrial Strategy…)
Early engagement with healthcare system decision makers and payers is a key enabler for the journey
along the evolving product development to adoption pathway
DIT = Department for Trade and Investment
MHIR = National Institute for Health Research
EMA = European Medicines Agency
MHRA = Medicines and Healthcare Products Regulatory Agency
AHSNs = Academic Health Science Networks
NHSI = NHS Improvement
NHSI
NHS
ENGLAND
Cancer
Drugs
Fund
MHRA
(& notified
bodies)
NIHR
DIT
50

51. The need for joined-up early dialogue with the
system
Dialogue with NICE and other stakeholders is often limited
Dialogue often occurs within the formal guidance process (often in high-risk
situations)
Companies generally interact with system stakeholders individually which can lead to
conflicting information or lack of clarity
Need for greater dialogue
Need for dialogue outside of formal guidance process
Need for more coordinated dialogue
Multi-
stakeholder
safe harbour
engagement
Company
NHS
Englan
d
Patient
orgs
Clinical
experts
NICE
51

52. 52
www.HealthTechConnect.org.uk

53. Thank you for listening
53
?
Sarah.Byron@nice.org.uk

54. What the Landscape
for Diagnostics is
telling us

55. Identifiying the
roadblocks to
diagnostic acceleration
and the opportunities
the system can cease
Daniel Berman, Lead of Global
Health Team, Nesta