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UK Awards £14M to New Centers to Spur Development and Uptake of In Vitro Diagnostics

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NEW YORK (GenomeWeb) – The UK National Institute for Health Research (NIHR) has awarded £14 million ($18.7 million) to support new medical technology and in vitro diagnostics cooperatives (MICs) around the country.

Eleven sites have been established across Britain to enable the development of tests and technologies within the UK National Health Service, as well as to evaluate commercial IVDs. Funded for five years, the MICs are expected to commence operations as of January 1, 2018. Teams of academics and clinicians involved in healthcare are tasked with fulfilling the aims of the MICs.

The NIHR announced the funding for the MICs earlier this month to coincide with the publication of the UK Office of Life Sciences' report on industrial strategies.

While cooperatives have been established to address the use of medical technology in a number of healthcare areas, such as surgery, brain injury, and trauma management, four of the 11 newly funded centers are specifically focused on IVDs. IVD Cooperatives have been established in London, Leeds, and Newcastle. A fourth, the NIHR Community Healthcare MedTech and IVD Cooperative, has been established in Oxford.

Matthew Hallsworth from the NIHR said that the new MICs will be an evolution of the NIHR's Healthcare Technology and Diagnostic Evidence Cooperatives that had been in place since 2013, with current funding concluding at the end of this year.

Hallsworth said that the new MICs "incorporate and retain the remits of" NIHR's earlier cooperatives, providing evidence for the adoption of new tests and supporting industry to develop new diagnostics. He added that the MICs were developed to address perceived unmet needs within the NHS that have not benefited to date from the availability of new diagnostics.

Going forward, the new cooperatives will serve as "centers of expertise" for both the development of medical technologies and for the generation of high-quality evidence on commercial IVDs by assessing them for clinical validity and the cost effectiveness of introducing them into care pathways. "It will be important that this evidence generation includes demonstrable, real-life applicability for commercially supplied IVDs," said Hallsworth. 

The MICs will also "catalyze NHS pull" to develop new concepts and create research protocols for platforms that are applicable across the service, Hallsworth said.

Another aspect of the MICs work will be engaging with various stakeholders in the UK. "MICs are expected to work collaboratively with clinical and other healthcare professionals, patients and patient groups, charities, industry, and academic researchers. Another anticipated benefit will be the development of a skilled and experienced 'cadre of researchers' in the MICs," he said.

Competitive research funding will also be available for MIC-related projects, Hallsworth noted, available either through the NIHR or other mechanisms. He said that such projects should "identify patient and clinical needs and issues from a frontline service perspective" and "devise medtech solutions and generate evidence for IVDs which address them." Other potential projects could support medical device development, health economics, and care pathway assessment, he said.

Each of the four IVD-focused MICs differs in terms of focus and expertise. The new NIHR London In Vitro Diagnostic Cooperative, for instance, received £1.3 million to both identify areas where new diagnostics, such as point-of-care tests, could be introduced into the healthcare system, as well as to evaluate the NHS's roster of current tests and devices.

Elias Zapantis, business and marketing manager at the London cooperative based at Imperial College London, said the MIC is focused on nine areas of clinical impact: gastrointestinal diseases, cancer, hematology, infectious diseases, respiratory diseases, emergency care, trauma and critical care, primary care, and metabolic medicine.

The cooperative is a partnership between Imperial College Healthcare NHS Trust, Royal Brompton & Harefield NHS Foundation Trust, and the Royal Marsden NHS Foundation Trust.

In its new role, the NIHR London IVD Cooperative will work on spurring the adoption and development of new tests. To accomplish this, the NIHR London IVD Cooperative will assess  how disruptive a technology might be, identifying factors that will improve uptake, and finding ways to mitigate any risks associated with it.

"We work closely with clinicians, patient representatives, and the companies that develop [the tests] — ideally from the early stages of the product development to undertake research and generate the evidence needed to inform their product development," said Zapantis.

"It is important to understand the need that the device is trying to address" and better understand where in fits in the clinical pathway," he said. "Such an understanding allows us to identify the barriers to adoption that may hinder the uptake of the technology if not addressed appropriately," he noted.

The NIHR London IVD Cooperative will also engage with stakeholders to "gauge their opinions and suggestions on how they believe the device should be placed in the clinical setting," Zapantis said.

"Based on this information and on the available literature and health economics, we create various economic models which demonstrate with as much details as possible the impact that such innovation may have on the appropriate use of resources and the potential improvement on health outcomes," he said. "All this evidence, coupled with evidence from clinical studies, creates the value proposition of the device, which supports the uptake of that innovation."

While the NIHR London IVD Cooperative has yet to commence operations, Zapantis stressed that molecular tests will provide a "crucial element" in its activities. "In order to harness the wealth of existing and emerging biomarkers and new technologies, we have a dedicated clinical lead on biomarkers who, with the support of the methodology team, will aim to assess which of those can be clinically validated and show their clinical utility," he said.

The NIHR's Community Healthcare MIC is hosted by the Oxford Health NHS Foundation Trust, and is based at the University of Oxford's Nuffield Department of Primary Care Health Sciences. It also builds on the work of NIHR Diagnostic Evidence Cooperative Oxford, which has evaluated point-of-care diagnostics since 2013.

Phil Turner, research and industry liaison for the Oxford MIC, said that like the other cooperatives, the Community Healthcare MIC will partner with commercial medical technology developers to ensure new concepts are evaluated, applicable in the NHS, and have a clinical benefit.

In particular, it aims to expedite the evaluation and deployment of tests in areas such as antibiotic prescription, child health, and chronic illness, with a focus on home and community care.

"We are the only MIC that will cover both in vitro diagnostics and medical technologies," said Turner. "We will also focus on community healthcare and new models of care outside of the traditional hospital environment, including what we would term 'ambulatory care'," he said.  "Due to the nature of the clinical settings in which we operate, we will continue to work largely with rapid point-of-care diagnostic tests and evaluation thereof."

Turner noted that most NHS patient contacts occur in community settings like general practitioner offices and pharmacies, which lack access to new diagnostics. "New tests are not well positioned in care and inadequately evaluated for benefit to patients," he said. Turner also noted that, given its background in community care, many of the Community Healthcare MICs researchers are also primary care physicians and GPs. Over the next five years, the MIC will work to encourage the development and adoption of new tests that will benefit community care.

"Technologies could be anything we consider relevant and promising," said Turner, "including molecular tests."

The other two NIHR IVD Cooperatives are in Leeds and Newcastle and are similarly specialized.

Helen Radford, operational and scientific manager of the NIHR Leeds IVD Cooperative, said that her center will focus on oncology, including renal, prostate, and colorectal cancer, multiple myeloma, and primary cancer care; musculoskeletal diseases; infection diagnostics, including first-line tests and assays for determining antibiotic resistance; and renal medicine for indications such as acute kidney injury, chronic kidney disease, and kidney transplantation.

Tests evaluated at NIHR Leeds IVD Cooperative will be assessed with four "cross-cutting themes" in mind, including health economics, health informatics, clinical trials through the Leeds Institute of Clinical Trials Research, and multidisciplinary pathology.

According to Radford, the NIHR IVD Leeds Cooperative aims to "provide insight into clinical needs and trends, rapid and high-quality health technology evaluations, and assistance with government and private-sector funding." The cooperative will also be involved in the design and planning of research projects, and will work with stakeholders to develop a "clear pathway" for test adoption, she said.

John Simpson, director of the NIHR Newcastle IVD Cooperative, said his MIC will be focused on aging, including long-term conditions that affect older people andinfectious diseases, as well as stratified medicine, which he defined as trying to distinguish different subsets of patients with any given disease.

"Our aim will be to study IVDs that apply to those three themes and evaluate those with the intention of improving tests, including molecular tests, that become available for patients," he said.

According to Simpson, the new MICs in general should support an easier, clearer route for NHS adoption of new tests. "The evidence base has been less strong and I think companies find the regulatory route relatively opaque," said Simpson. "The MICs will help to clarify that route."

Looking ahead, he said the metric of success for the MICs would be faster delivery of diagnostic tests into the NHS. "At the moment, the process can be relatively slow," said Simpson. "All of the MICs are working closely together to improve strength of evidence of these diagnostics so that we can get them approved faster."