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NHS Innovation Lab Helping Dx Test Developers Validate, Commercialize Assays


NEW YORK – A little more than a year after its inauguration, a UK National Health Service's laboratory is using the COVID-19 pandemic as an opportunity to help guide diagnostic test developers through the development process, both for the coronavirus and other diseases. 

The NHS Innovation Lab, which is part of the NHS' Integrated COVID Hub North East and hosted by the Newcastle upon Tyne Hospitals NHS Foundation Trust, has been part of the UK's response to the COVID-19 pandemic since it opened in January 2021, said John Tyson, head of the lab. 

The Integrated COVID Hub North East includes a Lighthouse Laboratory for exclusively processing COVID-19 tests and providing a national variant of concern surveillance service, a regional Coordination and Response Center that shares data and resources with partners to respond to the pandemic, and the Innovation Lab, which has specialist facilities to help evaluate and validate new diagnostic technology.

As the pandemic continues, there are "so many new COVID-19 diagnostics" that need to be assessed, and the Innovation Lab has provided a variety of resources to help test developers and manufacturers move toward commercialization, Tyson said. The lab has helped run analytical and clinical validity studies for some of these tests, along with usability studies, but its main role has been providing COVID-19 patient samples to use for these studies, he said. 

The lab has an "open door" policy, Tyson said, for communicating with any diagnostic developers that come knocking — most of the partners working with the lab, including QuantuMDx, have approached the lab of their own volition, although Tyson noted that the lab has also participated in a few nationally led diagnostic validation programs. The team works with small, medium, and large companies, including large multinationals, at all stages — from startups to established firms both in the UK and beyond, a spokesperson for the company said.

So far, the lab has worked with 12 companies on 21 different products, several of which have come back for additional projects, including validating further targets on their platforms, Tyson said.

Depending on what a developer needs, the lab tries to accommodate it based on its capacity, which Tyson said can be hard since the lab is in a busy clinical setting. For the most part, the lab has been providing COVID-19 samples for diagnostic tests, with a relatively even split between molecular and lateral flow antigen tests, he said, although it has helped with some serology tests as well. 

One problem diagnostic developers can face in validating their tests is that most samples available are residual and thus not as compatible with their assays, particularly if those assays are relying on novel technologies, Tyson said. The lab's sister COVID-19 testing lab in Gateshead has provided 15,000 COVID-19 samples for the Innovation Lab to put into a biobank. That biobank has allowed the Innovation Lab to provide primary samples to diagnostic developers to help improve the validity of their tests, he said.

The lab has served diagnostic firms at all stages of test development, Tyson said — some have been in the middle of developing full platforms, and for those, the lab has mainly provided clinical material for early-stage testing. But the more common use for the lab is developers using the lab's infrastructure to amass clinical data to support the performance of their tests, Tyson said. 

Some of the products it has helped develop have gone to market, including QuantuMDx's Q-POC SARS-CoV-2 assay, a microfluidic point-of-care test that received CE marking in July. The Innovation Lab was one of the sites used for validation of that test. 

Jonathan O'Halloran, CEO of QuantuMDx, said that when developing the test, the firm had trouble getting ahold of good clinical samples for validation. Working with the Innovation Lab meant the company could get access to those samples, while the lab also recognized the importance of speed and high-quality studies. While the firm originally was just interested in using the lab to get access to samples, the firm then expanded its work to include validation studies to support the firm's CE mark application, O'Halloran said. 

QuantuMDx is currently doing another study with the lab for the SARS-CoV-2 test with different sample types, he noted, saying that the firm feels the lab is reliable and easy to access. The company also plans to develop a broader menu of tests, including ones for human papillomavirus and hepatitis and a respiratory panel, and will likely work with the Innovation Lab on some, if not all, of those, he added. 

The Newcastle upon Tyne-based firm is also interested in working with the Innovation Lab on health economic studies to make a financial case to payors for the benefits of its tests and platform, O'Halloran said. 

The speed with which the lab can collect high-quality samples is "incredible," according to O'Halloran, especially since the regulatory path to get tests cleared is becoming more onerous. "With the extra regulatory challenges that we are facing with [In Vitro Diagnostic Regulations] in Europe and the [Coronavirus Test Device Approvals] now in the UK, getting that front-end of data gathering to run quickly and efficiently is incredibly important," he said. 

However, the lab remains hands off in the regulatory sphere, Tyson said. Although members of the lab try to keep up with the regulatory landscape, it doesn't take the lead on regulatory pathways and tends to direct companies to regulatory consultants for help. Tyson added that most companies come to the Innovation Lab with regulatory plans already in place. 

The lab is funded through the UK's Department of Health and Social Care, but Tyson said the lab's ambition is to be self-sustaining, recovering the costs of what it's providing but not profiting off the tests it helps validate. The services, such as provision of samples, are paid for by the companies, who are charged based on what's needed and how long it takes, Tyson said. The Innovation Lab holds no commercialization or intellectual property rights for the tests it helps develop.

Most of the work is completed in two months or less, Tyson said, although it varies depending on the type of project. Some projects have taken only two weeks, but often it takes longer to get access to samples, he said.

The Innovation Lab also has plans outside of COVID-19 testing, he noted. COVID-19 testing is "where demand is most prevalent," but the Innovation Lab is seeing interest in other types of in vitro diagnostic testing, including oncology and other types of infectious disease. The model is the same regardless of what kind of testing is being done, Tyson added, but the lab has been "having discussions" beyond COVID-19, although he emphasized that there is still "quite a lot of demand" for COVID-19 testing.

"We want to try and meet the needs of diagnostics developers," Tyson said. "Right now, a lot of them need access to COVID-19 samples or they need their tests evaluated … but we want to be helping develop similar tests for anything else."