11 May 2023
What Test, Where and Why?
Key considerations for diagnostic developers
The NIHR Newcastle In Vitro Diagnostics Co-operative (MIC) and the North East Innovation Lab (NEIL) support diagnostic developers as they navigate the development and evaluation process to bring their tests to patients.
Diagnostic test developers need to consider many elements when designing a test and taking it to market.
- The first is identifying whether the test tackles an unmet need and the factors that will enable or prevent the diagnostic from being widely used.
- Once they have a test, then evaluating their product’s performance is essential, which means considering methodology and protocol development and “testing the test” with clinical samples.
- After diagnostics have been tested and evaluated in the lab, developers need to consider how to best design and analyse the test in a clinical performance study, as well as building health economic models to support adoption and use.
The close partnership between the NEIL and the MIC is an integral part of Diagnostics North East, strengthening the North Easts diagnostics assets, bringing tests through to patients. More information on this collaboration and integrated working can be found here.
Diagnostics North East Conference interactive breakout session
Amanda Winter, diagnostic evaluation healthcare scientist, from NEIL, and Tim Hicks, clinical scientist from the NIHR Newcastle MIC, led two interactive workshops as part of the 2023 Diagnostics North East Conference.They shared their experience with over 110 delegates from over 50 organisations. They put attendees in the “hot seat” as the key decision-makers and consumers to roll out a vital test for prostate cancer to key NHS markets.
Attendees became the patient, GP, urologist, commissioner, developer, or laboratory scientist. In these groups, delegates identified the key priorities and the factors that might influence the development and evaluation of a new diagnostic. The groups also chose their ideal test from three possible tests for prostate cancer.
Amanda and Tim provided each group with an overview of a care pathway illustrating the main sequence of interactions a patient experiences as they move through the healthcare system with the symptoms of prostate cancer. The care pathway also emphasised key situations where a new diagnostic may help with clinical decision-making.
- Vital to compare the key benefits of a new diagnostic against the current tests on the market, such as quicker turnaround time and value for money
- Developers need to generate evidence to demonstrate the test’s accuracy, safety and usability to ensure it gains regulatory approval
- Requirements are dependent on where the test fits in the care pathway
- Important to consider aspects such as the cost of manufacturing the test and the market size, to ensure that there’s a viable route to market
- Most groups preferred the quickest, less invasive, test that would take place in a GP surgery or pharmacy
- Some groups suggested a two-step process so patients could have a second more sensitive and expensive test if necessary
“We can validate a test independently by testing how it works in a lab. We can identify the population group it will help, where the clinical needs are in the NHS and potentially where it would fit in a patient care pathway. This means that diagnostic developers have a wealth of information and evidence, both technical and qualitive, to support their approaches for investment and adoption. We can tighten up the evidence and remove uncertainty.”
“It was great to see everyone so engaged in this workshop, and we had some good debate on what would qualify as a ‘good test’. It really stressed that it depends on more than just accuracy, but other factors like the different decision-maker’s perspectives and where in the patient pathway it is used. I hope that everyone came away with an appreciation as to the importance of strong evidence generation for diagnostic development, and that thinking about this earlier on can really make a difference.”
Feedback was positive with 100% respondents rating the session as excellent or very good:
“This was a really great interactive workshop. Everything about it was good.” Geoff Hale – Chief Executive Officer at mAbsolve.
“It really couldn’t be improved. Enjoyable and interesting.” Paul Marshall – Chief Executive Officer at Rapid Fluidics Ltd.
“I thought it was excellent – well organised, relevant and interactive.” Marianne Ismail – Chief Executive Officer at Microbira Ltd.
“Fantastic example to educate and spark debate on the constraints and compromises when taking a test to market.” Anna Cornfield – Client Partnerships Lead at Ambit, a Life Sciences Talent Consultancy.
Read more about the Diagnostics North East Conference 2023
Register interest in the NIHR Newcastle MIC’s training courses