Study adds to understanding about utility of ultra-sensitive cardiac troponin measurement in diagnosing and predicting cardiovascular syndromes

ALAMEDA, Calif., March 13, 2018 — Cardiac troponin I (cTnI) concentrations measured with the Singulex ultrasensitive cTnI assay, powered by Single Molecule Counting technology, were associated with a higher prevalence of coronary artery disease (CAD) and independently predicted cardiovascular events in patients with obstructive and non-obstructive CAD, according to a study published in the Journal of the American Heart Association.

Cardiac troponin is a well-established biomarker currently used in emergency departments to help diagnose acute myocardial infarction (AMI) in patients who present with acute chest pain. Findings from the Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA) study extend to the growing body of evidence supporting the use of ultrasensitive cTnI measurement in predicting and ruling out CAD outside of the emergency department setting.

"Our results add novel and substantial clinical context to high-sensitivity cardiac-troponin concentrations in a commonly-encountered patient population, while also setting the stage for analyses of how high-sensitivity cardiac troponin may be leveraged in clinical trials of therapeutic intervention for such patients," said James Januzzi, Jr, MD, Physician in the Cardiology Division at Massachusetts General Hospital, the Hutter Family Professor of Medicine at Harvard Medical School, and Senior Cardiometabolic Trials Faculty at the Baim Institute for Clinical Research.

The CASABLANCA study suggests broader potential of cTnI measurement in the chronic setting enabled by ultrasensitive testing technology. With up to 1000 times more sensitivity than existing technologies, Single Molecule Counting reveals the presence or absence of disease more clearly and definitively than was possible before. The Singulex ultrasensitive cTnI assay using proprietary Single Molecule Counting technology is the first test to quantitatively measure cardiac troponin down to femtogram-per-milliliter levels, far lower than existing high sensitivity troponin immunoassays, enabling unprecedented insight into cardiovascular disease.

About the CASABLANCA study

In this single-center study, cTnI was measured in 991 patients without prevalent AMI undergoing diagnostic coronary angiography using the Singulex ultrasensitive cTnI assay. The patients were followed for a mean of 3.7 years for incident AMI, heart failure, cardiovascular death, and all-cause mortality. Patients with cTnI above the 99th percentile had a higher degree and number of stenotic lesions, and cTnI independently predicated obstructive CAD. Time to cardiovascular event was shorter among patients with elevated cTnI, and cTnI above the 99th percentile predicted incident AMI, cardiovascular death, and all-cause death.

"High-sensitivity cardiac troponin is a powerful predictor of the presence of CAD in patients sent for angiography not thought to have acute AMI. High-sensitivity cardiac troponin also predicts incident cardiovascular events in patients with either obstructive or non-obstructive CAD," concluded Dr. James Januzzi. "Our results will help to clarify the meaning of elevated high-sensitivity cardiac troponin in patients without AMI."

About Singulex

Singulex is an immunodiagnostics company at the forefront of Single Molecule Counting technology, a novel immunoassay technology recognized for unprecedented ultra sensitivity in the precision measurement of biomarkers. Singulex is the developer of the Singulex Clarity system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. In 2017, Singulex filed a 510(k) pre-market notification submission with the U.S. Food and Drug Administration for its cTnI assay. Additional assays to detect and rule out infectious and inflammatory diseases are in development. Singulex is also developing a point-of-care platform and exploring applications beyond the clinical setting. For more information, please visit www.singulex.com or www.singulexclarity.eu.