October 2, 2014 — Singulex Inc. announced the presentation of 10 abstracts at the European Society of Cardiology's (ESC) annual conference, which highlight the clinical utility of single molecule counting technology in the detection and quantification of biomarkers for cardiac disease, its comorbidities, and its risk factors. The conference, held in Barcelona, Spain from Aug. 30 through Sept. 3rd, also featured the first European preview of the Sgx Clarity System, a fully-automated, SMC-powered in vitrodiagnostics system targeted for launch to European hospitals and reference labs in 2016.
Three of the 10 abstracts accepted by ESC Congress 2014 were selected for oral presentations:
Ultra-sensitive troponin I strongly predicts incident coronary heart disease in the general population independently of traditional risk factors. Results from the MONICA/KORA Augsburg Case-Cohort Study
Wolfgang Koenig, M.D., Ph.D., professor of medicine/cardiology at the department of internal medicine II — cardiology at the University of Ulm Medical School, Ulm, Germany, reported that even modestly increased cardiac Troponin I (cTnI) levels are strongly associated with incident coronary heart disease (CHD) independent of standard risk factors. Using Singulex's highly sensitive cTnI research-use-only immunoassay, the long-term, population-based, prospective study found that cTnI was detectable in almost every healthy middle-aged subject. Incident CHD subjects had a higher baseline cTnI level than subjects who did not develop CHD (geometric mean 2.56 vs. 1.49 ng/L, p<0.0001).
"Singulex's highly-sensitive cTnI assay has enabled us to predict the incidence of coronary heart disease in the general population," stated Koenig. "I believe we now have the ability to gain greater insight into the cardiovascular risk profile of individuals who have not already been diagnosed with the disease."
Incremental value of single resting ultrasensitive cardiac Troponin I measurement to rule-out myocardial ischemia
Yunus Tanglay, M.D., department of cardiology, Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland, presented the results of a study that determined that cTnI levels complement non-invasive clinical assessments in patients with suspected coronary artery disease (CAD). cTnI levels were measured using Singulex's highly sensitive cTnI research-use-only immunoassay in 714 patients without known CAD before and after a bicycle exercise stress-test. Myocardial ischemia (MIS) was detected in 167 (23.4%) patients, and cTnI levels were significantly higher in patients with MIS (4.0 ng/L [95% CI 2.8-8.6] vs. 2.6 ng/L [95% CI 1.8-4.1], p<0.001). Diagnostic accuracy of CAD increased when both clinical judgment and cTnI levels were considered prior to a patient's stress test.
Plasma Kidney Injury Molecule (KIM-1) and Endothelin-1 (ET-1) are associated with worsening renal function in Heart Failure patients
Eitan Friedman, M.D., division of cardiovascular medicine, Vanderbilt University Medical Center, Nashville, Tenn., stated that this study was the first to demonstrate that KIM-1 was not only quantifiable in plasma, but also serves as a biomarker for worsening renal function in heart failure (HF) patients. Elevation in urinary KIM-1 is a known indication of renal tubule epithelial damage, however, this study was the first to establish the biomarker's utility in plasma. ET-1, a low abundance, known plasma biomarker of endothelial function, was also found to be independently associated with worsening kidney function in HF patients. Renal dysfunction is a comorbidity of HF.
The following abstracts were presented in a poster presentation:
- The clinical benefit of ultrasensitive cardiac Troponin I in the detection of exercise-induced myocardial ischemia
- Novel dual-biomarker strategy and clinical judgment in the detection of exercise-induced myocardial ischemia
- Subclinical inflammation quantified by Interleukin-6 for detection of exercise-induced myocardial ischemia
- Cardiac Biomarkers pMMP-9, IL-6, and ET-1 are elevated in asymptomatic patients at risk of heart failure and associate with disease severity
- Plasma Kidney Injury Molecule (KIM-1) and Endothelin-1 (ET-1) are associated with worsening renal function in Heart Failure patients
- Glucagon like peptide-1 and blood pressure in young, healthy adults: a population-based study
- Plasma glucagon-like-peptide 1 and body fat mass among young and healthy adults
- Plasma endothelin-1 and risk of obstructive sleep apnea among young and healthy adults
Commenting on the significance of the abstract findings presented at the Congress, Guido Baechler, president and CEO of Singulex, stated, "Cardiovascular disease is the leading cause of death in the European Union, and thanks to our academic collaborators, we are even more confident that our SMC technology can offer a means to better detect, assess, and manage CVD patients, along- with associated comorbidities and risk factors. As these study findings indicate, with the launch of the SMC technology-based Sgx Clarity System in 2016, European physicians will have at their disposal a powerful diagnostic tool and unique portfolio of tests to drive evidence-based management of patients and improved outcomes."
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