A north east collaborative is helping to transform the diagnostic development process in the region.
The North East Innovation Lab and the National Institute for Health and Care Research (NIHR) Newcastle In Vitro Diagnostic Co-operative, a member of the MedTech & In vitro Diagnostics Co-operative (MIC) network are working closely together to improve the process that diagnostic developers must navigate to bring much needed tests to patients.
The innovation lab’s services include independent evaluations for new and emerging diagnostics; methodology and protocol development and bespoke sample collection. The lab has a biobank which holds around 22,000 carefully curated samples, including blood, serum and saliva, with associated detailed metadata.
This complements NIHR Newcastle MIC’s services supporting diagnostic developers at the beginning of the process to identify unmet needs for tests and how they might be used. The MIC also offers help with the design and analysis of clinical performance studies once devices have been tested and evaluated in the lab, as well as building health economic models to support adoption of a test into the NHS.
The collaboration and closer integrated working bring a number of benefits for clients including specialist expertise in methodology and close working with NHS partners.
“Working with us reduces the amount of waste in the process with fewer ‘re dos’ of the work,” explains Amanda Winter, diagnostic evaluation healthcare scientist.
“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.”
Kile Green, research methodologist at the MIC, explained that the complementary services provide a comprehensive package of evidence for test developers.
“We speak to our clients and partners to look at what changes need to occur in the healthcare pathway to enable a diagnostic to come into the NHS.
“We provide diagnostic accuracy testing and check utility – whether the product is usable – which is closer to what the innovation lab does. But our approach is different as we will gather information by speaking to the people who will use it, rather than testing in a lab.”
Kile explains that the work of the MIC begins at an early stage before the lab might be involved, then some work happens in parallel, and further work once the lab has finished testing.
“A professor may come to us with an idea to consider if it’s worthwhile pursuing before they invest time and money into it.
“Then, whilst the lab’s evaluation work is going on, we’re doing some of the analytical work, such as health economics – looking at the efficiency, effectiveness, and cost of a test, whether the test is feasible to fit into the healthcare pathway, what the population might be, for example if it is aimed at people with a particular condition or a sub type.”
Amanda explained the role of the ‘iterative testing’ carried out by the lab.
“This part of the process, where we keep testing and refining, is important to the test’s use, as it influences the properties of the test that we work on.
“For example, if the test is to be used in the patient’s home, it can’t be too big. Or if it is too invasive, then a nurse may not use it. Or if it’s a test for a condition for which there’s not onward treatment then it might not be used.
“It’s important to get that kind of lab development work done as early as possible to inform the test.”
In the near future test developers will need more evidence of performance evaluation before they get their test CE marked – an indicator of a product’s compliance with EU legislation – meaning the threshold for developers is increasing.
“There’s many stages to progress through before you can CE mark the product and we are able to provide appropriate evidence required to support regulatory submissions,” said Amanda.
Both organisations have refined the triage process between them so that developers have a clear route to access the expertise they require. They will also signpost developers to support in the wider diagnostic network.
They work as part of the Diagnostics North East partnership that supports the development, evaluation and adoption of cutting-edge diagnostics for better patient outcomes.
