Title: NIHR Newcastle In Vitro Diagnostics Co-operative (short name: NIHR Newcastle IVD Co-operative)
Funder: Department of Health and Social Care

Abstract: The North East MIC seeks to develop a vibrant regional centre of excellence for evaluation of diagnostic tests within a national framework of MICs and other NIHR infrastructure. Our overarching aim is to provide better diagnostic tests for patients and the NHS. We shall achieve this by consolidating and expanding the most successful elements of our established Newcastle DEC. We shall provide diagnostics companies with rapidly responsive, effective and independent expertise, while continuing to build academic excellence in the methods used to evaluate diagnostic tests. The MIC will be built on core foundations of clinical research accessibility (Newcastle has had more open clinical studies on the national portfolio than any other centre for the last 5 years), research excellence (Newcastle was ranked 4th for clinical medicine research intensity in the last UK Research Excellence Framework) and diagnostics experience (acquired by the Newcastle DEC). Newcastle has accumulated a unique set of diagnostics infrastructure awards recently, brought together as Newcastle Diagnostics (described in more detail in our &ldquo;Strategy&rdquo; section). Our MIC will be at the core of Newcastle Diagnostics, which has a team dedicated to attracting industry and improving the efficiency of interactions with companies. We have expanded our strategic partnerships to increase access to companies and enhance the quality of our academic offering. In particular, the new diagnostics section of MRC-Technology will establish an exclusive partnership with our MIC, based on recent successful collaborations with the DEC. In addition, we have partnered with the other key organisation in the North East providing improved clinical access to the diagnostics industry (MedConNecT North). Furthermore, in response to feedback from industry we have established a partnership with the renowned diagnostics evaluation unit at the University of Exeter, in order to benefit from their excellence in health economics. The success of the Newcastle DEC was built on the professional development of new, dedicated experts in diagnostic evaluation. These methodologists have driven the DEC s engagement with over 100 companies to date. Our strategy is to expand the number of high quality methodologists to meet the rapidly increasing demand for our services and skills. The methodologists will evaluate diagnostic tests within 3 themes defined by huge unmet clinical need: infection (which was a particular focus for the Newcastle DEC); &ldquo;stratified medicine&rdquo; (which is the concept of tailoring treatment to an individual s results and an a focus for research funders); and ageing and long-term conditions (reflecting Newcastle s internationally-renowned expertise in this area). Based on the strategies above, our short-term (1-year) aim is to establish the MIC within Newcastle Diagnostics and to increase our accessibility to industry. Medium-term (2-3 years) aims are to ensure steady increases in industrial contacts and academic grants, to deliver on existing grants and projects, and to complete training for our new methodologists. Long-term (4-5 years) aims are to establish an academic Centre for Diagnostic Evaluation, with a comprehensive training programme for future methodologists, and to achieve full and long-term financial self-sustainability for the MIC.

Lay abstract: The North East MIC seeks to develop a vibrant regional centre of excellence for evaluation of diagnostic tests within a national framework of MICs and other NIHR infrastructure. Our overarching aim is to provide better diagnostic tests for patients and the NHS. We shall achieve this by consolidating and expanding the most successful elements of our established Newcastle DEC. We shall provide diagnostics companies with rapidly responsive, effective and independent expertise, while continuing to build academic excellence in the methods used to evaluate diagnostic tests. The MIC will be built on core foundations of clinical research accessibility (Newcastle has had more open clinical studies on the national portfolio than any other centre for the last 5 years), research excellence (Newcastle was ranked 4th for clinical medicine research intensity in the last UK Research Excellence Framework) and diagnostics experience (acquired by the Newcastle DEC). Newcastle has accumulated a unique set of diagnostics infrastructure awards recently, brought together as Newcastle Diagnostics (described in more detail in our &ldquo;Strategy&rdquo; section). Our MIC will be at the core of Newcastle Diagnostics, which has a team dedicated to attracting industry and improving the efficiency of interactions with companies. We have expanded our strategic partnerships to increase access to companies and enhance the quality of our academic offering. In particular, the new diagnostics section of MRC-Technology will establish an exclusive partnership with our MIC, based on recent successful collaborations with the DEC. In addition, we have partnered with the other key organisation in the North East providing improved clinical access to the diagnostics industry (MedConNecT North). Furthermore, in response to feedback from industry we have established a partnership with the renowned diagnostics evaluation unit at the University of Exeter, in order to benefit from their excellence in health economics. The success of the Newcastle DEC was built on the professional development of new, dedicated experts in diagnostic evaluation. These methodologists have driven the DEC s engagement with over 100 companies to date. Our strategy is to expand the number of high quality methodologists to meet the rapidly increasing demand for our services and skills. The methodologists will evaluate diagnostic tests within 3 themes defined by huge unmet clinical need: infection (which was a particular focus for the Newcastle DEC); &ldquo;stratified medicine&rdquo; (which is the concept of tailoring treatment to an individual s results and an a focus for research funders); and ageing and long-term conditions (reflecting Newcastle s internationally-renowned expertise in this area). Based on the strategies above, our short-term (1-year) aim is to establish the MIC within Newcastle Diagnostics and to increase our accessibility to industry. Medium-term (2-3 years) aims are to ensure steady increases in industrial contacts and academic grants, to deliver on existing grants and projects, and to complete training for our new methodologists. Long-term (4-5 years) aims are to establish an academic Centre for Diagnostic Evaluation, with a comprehensive training programme for future methodologists, and to achieve full and long-term financial self-sustainability for the MIC.

Research activity codes: 4.5 RESOURCES AND INFRASTRUCTURE (DETECTION)
Health categories: STROKE;GENERIC HEALTH RELEVANCE