Singulex, Inc., the developer and leading provider of Single Molecule Counting (SMC(tm)) technology for clinical diagnostics and scientific discovery, today announced new data highlighting the Company's ultrasensitive Erenna(r) Immunoassay System in the detection of cardiac troponin-I (cTnI). Two studies utilized the Erenna System to measure previously undetectable levels of cTnI in order to assess cardiovascular disease risk in rheumatoid arthritis (RA) and heart failure (HF) patients. The data were presented at the American Heart Association Scientific Sessions in Dallas, Texas.

The research (Abstract #14247/1054, The Cardiac-Specific Troponin-I Predicts the Burden of Coronary Artery Atherosclerosis in Rheumatoid Arthritis) led by Matthew Budoff, M.D., Professor of Medicine at the David Geffen School of Medicine at UCLA and Director of Cardiac CT at Harbor-UCLA Medical Center, demonstrated that the concentration of cTnI, measured using Erenna, was directly associated with the severity of coronary artery disease in patients with RA. cTnI concentrations were found to be as predictive of coronary atherosclerosis as traditional cardiovascular tests, including coronary artery calcification (p=0.013), segmental stenosis score (p=0.024), segmental involvement score (p=0.019) and plaque burden score (p=0.029), measured via Multi-detector Computed tomography calcium scoring and non-invasive angiography.

"Patients with rheumatoid arthritis are known to be at a 3-fold increased risk for developing cardiovascular disease. However, the challenge is to easily identify which of these patients have disease and treat them accordingly," said Dr. Budoff.  "Our research shows that the ability to measure extremely low levels of cTnI via a simple blood test enables physicians to determine the extent of coronary artery disease in rheumatoid arthritis patients. Using this information, physicians can create proactive treatment plans, ultimately providing better care to patients."

The study (Abstract #14953/5041, Serial Measurement of an Ultrasensitive Cardiac Troponin-I Predicts Cardiovascular Outcomes and Ventricular Remodeling in Chronic Heart Failure) led by James Januzzi, Jr., M.D., Director, Cardiac Intensive Care Unit at Massachusetts General Hospital, demonstrated that serial measurement of cTnI levels was able to predict future cardiac performance and risk in patients with HF.  Concentrations of cTnI at baseline, 3 months and 6 months of follow-up were higher in patients with cardiovascular events than in those without (18.0 vs. 8.6 pg/mL, p = 0.003; 16.4 vs. 8.7 pg/mL, p = 0.006; 13.6 vs. 9.3 pg/mL, p = 0.03) while patients with cTnI levels less than 10.88 pg/mL were found to have a lower cardiovascular event rate (p = 0.007).

"Identification of those heart failure patients whose disease will worsen over time is the first step towards slowing the disease's progression.  We found that Singulex's ultrasensitive cTnI assay can help us identify these at-risk patients," said Dr. Januzzi.  "In addition, we found that examining serial cTnI measurements not only proved more useful than single measurements alone for predicting risk but also recreates the manner in which a patient's health would be tracked by their doctor. This data shows that ultrasensitive measurement of cTnI over time is an important prognostic factor and provides predictive risk information for patients with heart failure independent of other risk factors."