Welcome to the Diagnostics North East Directory of Service
Your interactive guide to the diagnostic development pathway.
About our directory
Developing clinical diagnostics can be complex, but you don’t have to navigate it alone.
Our directory guides you through every stage of the pathway—discovery, development, evaluation, and adoption—providing practical insights and pointing you to the right teams at DxNE who can support you along the way.
Watch our video to learn how to use the pathway, connect with our experts, and unlock the full potential of your ideas.
Want to collaborate?
We are passionate about collaborating to co-create new innovations. If you are interested in strategic partnerships, data partnerships, or other collaborations (e.g. joint funding bids) please get in touch.
How to navigate our directory
By clicking on any part of the pathway, you can explore key theory – and connect with our highly skilled teams who can help. If you know the team you’d like to work with, visit their teams page below.
Search the Directory
If you know what service you’d like to access, please search here for a list of teams that can help!
Horizon Scanning
NHS Implementation
Post Market Surveillance
Basic research
Intended Purpose
Health Economics
Market Access Launch
Unmet Need
Requirements Identification
Target Product Profile
Pre-Clinical Evidence Generation
Clinical Evidence Generation
Regulatory Certification
Marketing & Business
Prototype Development
Value Proposition
TRL1
Basic Principles Observed & reported.
At this level we would expect to see – scientific ideas, biological markers identified, initial feasibility.
TRL2
Technology concept or application formulated
At this level we would expect to see – scientific ideas, biological markers identified, initial feasibility.
Consider: Test classification, data collection needs and future compliance pathways.
TRL3
Analytical and experimental critical function or characteristic proof-of-concept
At this level we would expect to see: initial lab data showing the test might work (e.g. detecting a disease marker in samples)
Consider: Test classification, data collection needs and future compliance pathways
TRL4
Technology basic validation in a laboratory environment
At this level we would expect to see: analytical validation – test performance in controlled lab conditions (accuracy, sensitivity, specificity)
Consider: Good Laboratory Practice (GLP) or equivalent. Begin generating analytical validation data under traceable, quality-controlled conditions.
TRL5
Technology basic validation in a relevant environment
At this level we would expect to see: Clinical validation begins – testing in patient samples, pilot studies in clinical setting.
Consider: Begin planning for regulatory strategy. In the EU/UK: Prepare for IVDR/UKCA classification.
TRL6
Technology model or prototype demonstration in a relevant environment
At this level we would expect to see: Stronger clinical data, how the test performs in real clinical workflows, potential health impact.
Consider: CE/UKCA conformity assessment for performance studies (EU/UK)
TRL7
Technology prototype demonstration in an operational environment
At this level we would expect to see: Real World Evidence (RWE) – test impact on clinical decisions, patient outcomes, workflow, cost effectiveness
Consider: Post-market clinical follow up required under IVDE/UKCA
TRL8
Actual technology completed and qualified through test and demonstration
At this level we would expect to see: Regulatory submissions (e.g. CE marking, FDA) health economic studies, payer evaluations
Consider: CE/UKCA marking (EU/UK) through notified bodies, based on risk class.
TRL9
Actual technology qualified through successful mission operations.
At this level we would expect to see: post market surveillance – continued data collection on performance and outcomes.
Consider: Undergoing audits (e.g. MHRA).
Meet the expert teams who make up the diagnostics pathway across the North East. If you already know which team you’re looking for, head straight to their dedicated page, or browse the list below to discover each team in more detail.
- Health Innovation North East and North Cumbria (HI NENC)
- NovoPath
- North East Innovation Lab
- MedConnect North
- Medical Device Development Service (MDDS)
- NIHR HealthTech Research Centre (HRC) in Diagnostic and Technology Evaluation
- NIHR Innovation Observatory
- Newcastle Hospitals Health Technology Assessment (HTA) Group
- Newcastle University Business Development & Enterprise
- Newcastle Joint Research Office (NJRO)
- NIHR Research Support Service (RSS)
- NIHR Commercial Research Delivery Centre (CRDC) Newcastle
Newcastle University Research Facilities
Newcastle University Research Facilities bring together an integrated network of advanced capabilities and specialist teams to support diagnostics innovation across the full development pipeline. From discovery science and clinical trial delivery to data analytics, health economics, and regulatory insights, we work collaboratively with academic, industry, and NHS partners. Our services are open-access and designed to accelerate the journey from concept to clinic—ensuring innovative diagnostics reach the people who need them most.
Find out about each of our facilities below:
- Genomics Core Facility
- Bioimaging unit
- Infectious Diseases Facility
- Structural Biology Services
- Newcastle University Flow Cytometry Core Facility
- Pre-clinical in vivo Imaging (PIVI)
- Bio-screening Facility
- Protein and Proteome Analysis Facility
- Newcastle Central Biobank Facility
- Bioimaging unit
- Newcastle Hospitals Commercial Enterprise Team