Newswise — Singulex, a global immunodiagnostics company pioneering ultra-sensitivity in the precision measurement of protein biomarkers, today announced it has applied the CE Mark to its ultra-sensitive troponin I assay (cTnl), the first offered on the Sgx Clarity® system, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology.

The Singulex Sgx Clarity cTnl Assay quantitatively measures the biomarker troponin at levels far lower than existing technologies. The Sgx Clarity cTnl Assay is indicated to be used in conjunction with clinical evaluation for ruling out cardiac ischemia in patients suspected of having coronary artery disease (CAD). Efficient rule-out helps avoid the costs and adverse effects of additional expensive and potential unnecessary testing, such as stress tests, and allows clinicians to focus resources on the sickest patients.

“This is a tremendously attractive concept, especially, from an urgent care perspective,” said Alessandro Sionis, MD, Director of the Acute and Intensive Cardiac Care Unit, Hospital de la Santa Creu i Sant Pau, Universitat de Barcelona. “The increased sensitivity and analytical precision of this troponin I assay has the potential to greatly improve the safety and efficiency of myocardial ischemia rule-out in patients especially those presenting to the Emergency Department with chest pain.”

Up to 100 times more sensitive than existing technologies, Single Molecule Counting-based diagnostics are the first ultra-sensitive tests to routinely and effectively identify minute quantities of protein biomarkers, giving clinicians greater insight, confidence, and certainty in disease detection, rule-out and patient management.

“This is a significant milestone for Singulex as well as for laboratorians, clinicians, and patients,” said Guido Baechler, president and chief executive officer of Singulex. “We are working closely with European clinical research sites to develop best practices and training for optimal introduction and utility of our Sgx cTnl test for cardiac ischemia rule-out in patients suspected of having coronary artery disease.”

The Singulex proprietary Single Molecule Counting technology has been validated in clinical studies involving more than 130,000 subjects, resulting in over 130 peer-reviewed publications. The company will submit data for regulatory clearance of the Sgx Clarity system and the Sgx Clarity cTnI Assay in the United States later this year, anticipating U.S. Food and Drug Administration clearance in 2018.

About Coronary Artery Disease Coronary artery disease is the leading cause of death worldwide. A significant proportion of ambulatory health care visits are for evaluation of patients with suspected CAD, with an estimated 1.5 percent of the population presenting with chest pain every year. An estimated $108.9 billion are spent annually on CAD treatment. Optimizing the process for assessing patients presents an opportunity to improve patient outcomes and direct health resources to where they are most needed. 1

About Singulex, Inc. Singulex is an immunodiagnostics company at the forefront of Single Molecule Counting technology, a new immunoassay technology recognized for unprecedented ultra-sensitivity in the precision measurement of biomarkers. Singulex is the developer of the Sgx Clarity System, a fully-automated, in vitro diagnostics platform powered by Single Molecule Counting technology. With up to 1,000 times more sensitivity than existing technologies, Single Molecule Counting reveals the presence or absence of disease more clearly and definitively than was possible before. Assays to detect and rule out cardiac, infectious, and inflammatory diseases are in development. Singulex is also developing a point of care platform and exploring applications beyond the clinical setting.

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REFERENCE Skelly AC, Hashimoto R, Buckley DI, et al., Noninvasive Testing for Coronary Artery Disease Comparative Effectiveness Reviews, No. 171.Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Mar., Accessed May 8, 2017