Analysis of the cardiac troponin of more than 4,000 patients with stable ischemic heart disease via single molecule counting technology developed by Singulex, Inc. of Alameda, Calif., has demonstrated clear utility and clinical information in the analysis of cardiac health.
In stable patients with recent acute coronary syndrome, researchers used SMC™ powered cardiac troponin (cTnl) to successfully identify patient’s risk for worsening of their cardiovascular disease. Additionally, the Singulex-developed high-sensitivity cTnI biomarker demonstrated the potential for using the information to guide physician and patient decisions on how aggressive preventive therapy should be.
These findings were from a substudy of PROVE IT-TIMI 22 study led by Marc P. Bonaca, M.D. and David Morrow, M.D., at Brigham and Women’s Hospital and Harvard Medical School, and published in the Journal of the American College of Cardiology (Vol. 68, No. 3, 2016). PROVE-IT TIMI 22 was originally designed to test the efficacy of intensive versus moderate statin therapy in patients with stable coronary artery disease. This analysis assessed cTnI levels with Singulex’s proprietary SMC technology. A total of 4,162 blood plasma samples from the study were stored and tested with Singulex’s cTnI research-use-only assay.
Intensive preventive therapy
“Our findings support the potential broadening of a paradigm from viewing cardiac troponin solely as a transiently elevated diagnostic marker in the setting of acute injury to also using the information as a marker of ongoing heightened cardiovascular risk,” said Dr. Bonaca, principal investigator of the study. “This knowledge is particularly relevant in stable patients with ischemic heart disease, among whom there may be opportunities for more intensive preventive therapy.”
Data show a gradient of risk for cardiovascular death or developing heart failure across cTnI concentration. This gradient of risk was maintained even in patients with cTnI concentrations < 9 pg/mL. Additionally, in patients with cTnI > 9 pg/mL there was an absolute risk reduction of 3.5% in patients treated with intensive therapy, while in patients with cTnI < 9 pg/mL the risk only 0.44% with intensive statin therapy.
These findings demonstrate the leadership role of Singulex in the development and delivery of next generation immunodiagnostics. Collaboration with clinical investigators throughout the world has shown how cTnI, powered by SMC technology, can be used to better manage the care and treatment decisions in patients afflicted with cardiovascular disease.
“We find it remarkable that Singulex’s SMC powered cTnI assay could clearly identify these patients future risk for worsening of their disease,” said John Todd, Chief Scientific Officer at Singulex, Inc. “This is an important study that shows how our SMC powered cTnI assay can potentially be used to help physicians choose the aggressiveness of preventive therapy in patients with stable cardiac disease.”
SMC technology is available only from Singulex via CLIA clinical-lab services and has been developed for use on the Sgx ClarityTM System IVD platform, currently in European evaluation and not yet available for commercial sale. Sgx Clarity System will be previewed at the 68th AACC Annual Scientific Meeting & Clinical Lab Expo inPhiladelphia, PA, July 31 to August 4, 2016 at booth 3902. Pending review and evaluation of the Sgx Clarity System, CE Mark confirmation is anticipated in early 2017, with U.S. Food and Drug Administration clearance applications to be filed in 2017.