The University of Manchester has announced a strategic collaboration with U.S. company Singulex, Inc., a leader in the use of single molecule counting technology as a diagnostic tool.
The Company, a leader in next generation immunodiagnostics, has installed its SMCTM powered Sgx ClarityTM System in the Manchester Molecular Pathology Innovation Centre (MMPathIC) labs as part of the Company’s ongoing clinical evaluation ahead of an anticipated European CE-Mark declaration in 2017. The Sgx Clarity System, a fully-automated in vitro diagnostics platform currently under development, is designed to bring the benefits of Singulex’s SMC technology to hospital and reference labs worldwide.
This represents an important milestone in MMPathICs vision to get new biomarkers into clinical use in the NHS. The University of Manchester received £3M of Medical Research Council (MRC) and Engineering and Physical Research Council (EPSRC) funding for MMPathIC, one of 6 molecular pathology nodes, which has built an infrastructure of key expertise which can work with researchers, clinicians and companies in biomarker discovery and development.
Manchester Molecular Pathology Innovation Centre is utilizing the Sgx Clarity System to evaluate SMC powered high-precision cardiac troponin assays to guide disease rule-out in the high cost and high patient risk area of cardiac disease.
“The ability to access SMC technology in our own facility via the Sgx Clarity System is extremely valuable,” said Prof. Anthony Freemont, Director of the Manchester Molecular Pathology Innovation Centre at the University of Manchester. “Our clinical evaluation of the Sgx Clarity System is examining the economic impact of ruling-out coronary artery disease, with a view to the utility in the acute and community-based settings. We’re also looking at potential future applications in AMI, oncology and infectious disease. Already, I can see broad potential for clinical applications and the ability to inform physician decisions and help bring economic benefits to the broader health setting.”
The ability to access SMC technology in our own facility via the Sgx Clarity System is extremely valuable
“High-sensitivity testing of cardiac troponin is a game-changer for the diagnosis and treatment of cardiac disease,” said Prof. Rick Body, from The University of Manchester and Professor at the Royal College of Emergency Medicine. “We need high precision and sensitivity assays to definitively rule-out disease. Assessing cardiac biomarkers at levels previously unattainable will help physicians rule-out disease in patients suspected of having cardiovascular disease and hence focus on the patients with the greatest risk and need, while also helping to reduce the overall cost and risk for the patient and the health system.”
“Singulex is very excited to be working with our colleagues in the Manchester Molecular Pathology Innovation Centre” said Guido Baechler, president and CEO of Singulex, Inc. “It is critical for our company that we work with organizations that share our desire to deliver precision approaches for the transformation of patient care. As a recognized leader in the UK and across Europe, we feel MMPathIC will play an important role in the development of future assays and application of our technology to help improve health outcomes and reduce health care costs.”
Prof. Freemont added “The collaboration with Singulex is a great exemplar of the work that MMPathIC can do to support companies, whilst facilitating the translation of new tests to the clinic for the benefit of patients.”
About the molecular pathology nodes
Molecular pathology is a major tool in stratified medicine. Tiny samples of blood or tissue are taken from the patient – usually with minimal discomfort because of the small amount taken and the use of minimally-invasive methods of collection. The samples are then analysed for levels of large molecules (such as proteins and DNA). Combining these results with other information, such as imaging and clinical data, enables the precise subdivision of patients.
In 2014, the MRC produced a report that warned that, while UK investment in stratified medicine has reached nearly £200 million in the last four years, the UK capacity for molecular pathology needed to be increased in order to capture the potential patient and economic benefits stratification offers.
To support molecular pathology, the MRC and EPSRC have supported six nodes led by the universities of Edinburgh, Glasgow, Leicester, Manchester, Newcastle and Nottingham. Each node brings researchers, clinicians and industry together to develop molecular diagnostic tools, to enable stratification, in key disease areas
About Manchester Molecular Pathology Innovation Centre
MMPathIC addresses the challenges through the MRC report, through its pipeline model for working, which aims to bring key stakeholders (academia, clinical/ pathology service, and industry) into proximity, better define the developmental pathway, and offer cross-cutting training approaches to expand the skills base to support molecular pathology and diagnostic development. MMPathIC provides an environment to facilitate the translation of stratified medicine and biomarker research into usable tests that can be implemented within the NHS. The MMPathIC vision is to deliver at least six new biomarker tests or biomarker-based technologies to the clinic/market by October 2019. MMPathIC received £3M in funding from MRC and EPSRC, which was supplemented by a further £1.9M institutional and industry support.