Friday, March 24, 2017
Singulex, Inc., the creator of Single Molecule Counting immunodiagnostic technology, is expanding clinical evaluation of the Sgx Clarity™ system at clinical research sites across Europe. With multiple clinical research studies currently underway at a site in Spain and two sites in the United Kingdom, leading researchers and cardiologists across Europe recognize the potential value and utility of the in vitro diagnostics (IVD) platform to help bring greater sensitivity, accuracy and utility to understanding disease status, particularly in heart disease.
Singulex's proprietary Single Molecule Counting technology is already proven to allow greater analytical and clinical sensitivity and understanding of how biomarkers can guide health status, said Dr. Jorge Ordonez-Llanos, Professor of Clinical Biochemistry at Hospital de Sant Pau, Barcelona and former chair of the International Federation of Clinical Chemistry (IFCC) Task Force on Clinical Applications of Cardiac Biomarkers. With that clinically proven power, researchers can explore the potential for clinical use. At my site in Barcelona, we've already demonstrated the improved detection limit, analytical precision and functional sensitivity and are expanding clinical research studies to explore applications of the cardiac troponin-I (cTnI) biomarker to better manage patients and bring cost savings to our hospital.
The Sgx Clarity system, currently under development and not yet available for sale, is an IVD platform designed to bring the benefits of Singulex's Single Molecule Counting technology to hospital and reference labs worldwide.
Utilizing the Sgx Clarity system at St. George's University in London, we have observed performance of the investigational use only Sgx Clarity cTnl assay at the level which we believe meet the European Society of Cardiology (ESC) guidelines for the management of acute coronary syndromes, specifically to rule-in and rule-out patients, said Professor Paul Collinson, Professor of Cardiovascular Biomarkers at St. George's University Hospitals in London, UK. In our view this validates the utility of Singulex's IVD platform and reinforces the opportunity it may present to our understanding of heart and total health status.
Led by world-renowned clinical researchers in the fields of cardiology, immunodiagnostics and molecular pathology, the Sgx Clarity system is active in clinical evaluation at the following sites across Europe:
Barcelona, Spain: Hospital de Sant Pau – In collaboration with Professor Jorge Ordonez-Llanos, the Sgx Clarity system has been in-place in Barcelona since May 2016. A research study evaluating samples from 150 patients – now expanded to 300 – is utilizing Sgx Clarity cTnI assay to determine whether cardiac status in individuals with chest pain assessed in the emergency room could avoid complementary explorations of stress test, angio-CT or MRI. Additional clinical research studies are planned around the concept of ruling out the presence of CVD in those suspected of having it and subsequently guide appropriate utilization of supplementary procedures which could result in enhanced patient management and cost savings.
Professors Jorge Ordonez-Llanos and Juan Cinca-Coscollola, lead of the Cardiology Department at Hospital de Sant Pau, will evaluate the role of Sgx Clarity cTnI assay on a multimarker strategy for prognosis of readmissions in acute heart failure patients. The project is included on the Spanish Network of Acute Heart Failure, a nation-wide study sponsored by the Spanish Ministry of Health.
London, United Kingdom: St. George's University – Professor Paul Collinson, Professor of Cardiovascular Biomarkers, has completed analytical evaluation of the Sgx Clarity system's performance and with Professor Ordonez-Llanos plans on presenting the findings at an upcoming scientific Congress. Dr. Collinson will go on to test the WESTCOR study to investigate the ability of high-sensitivity cardiac troponin assays to rule out the presence of coronary disease in patients that present with suspected acute coronary syndrome.
Manchester, United Kingdom: University of Manchester – Professor Anthony Freemont, Director of the Medical Research Council-funded Manchester Molecular Pathology Innovation Centre at the University of Manchester, and Professor Richard Body, Professor of the Royal College of Emergency Medicine, are testing the Sgx Clarity cTnI assay in the Supersensitive Troponin for Admission Reduction (STAR) Study. The STAR study is evaluating whether use of Sgx Clarity cTnI assay on the Sgx Clarity system can enable doctors to rapidly rule out acute coronary syndrome with just one blood test, avoiding unnecessary hospital admissions and bringing substantial cost savings to the NHS health care system.
In addition to these three active sites, Singulex is engaged with researchers at other sites across Europe with a goal to expand Sgx Clarity system installation and evaluation. Potential sites in Italy, Germany, Norway and further sites in Spain and the UK will help expand the understanding of utility and value of the Sgx Clarity system.
Singulex is committed to extensive clinical validation of its Single Molecule Counting technology and its application via the Sgx Clarity system, its CLIA-licensed and CAP-accredited laboratory and future technology platforms in development. The Company anticipates additional peer-reviewed publications and presentations, expanding on the more than 130 peer-reviewed publications to-date, from the current investigations in Europe, along with future application in heart disease, infectious diseases, oncology, inflammation, and other high-cost and highly-prevalent diseases.
