Directory of Service

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

Regulations and standards

Patient and Public Involvement and Engagement (PPIE) and Research Inclusion (RI)

Biobanking

TRL1
TRL1

Basic Principles Observed & reported.

At this level we would expect to see – scientific ideas, biological markers identified, initial feasibility.

TRL2
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
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
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
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
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
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
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
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.

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: