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12-Dec-2018

Singulex Receives New, Broad Patent for Highly Sensitive Methods for Analysis of Troponin

Singulex announced today the granting of a significant European patent (EP 3168618) covering methods for determining myocardial infarction using any high sensitivity cardiac troponin assay with a sensitivity < 5 pg/mL.

“The global clinical market is rapidly adopting high sensitivity cardiac troponin assays to better manage patients suspected of having heart attacks,” said John Todd, PhD, Senior Vice President and Chief Scientific Officer of Singulex. “Our latest patent is, therefore, exceptionally broad and valuable because it covers any high sensitivity cardiac troponin-I method with a limit of detection of < 5 pg/mL, regardless of platform or technology, that is used to diagnose myocardial infarcts.”

Prior to Singulex’s discovery and disclosure in 2006 that high sensitivity assays can detect cardiac troponin in the blood of practically all healthy humans, it was widely believed that cardiac troponin was released from heart muscle only during and after a severe cardiac ischemic event, such as a myocardial infarct. Since then, Singulex actively collaborated with cardiologists to understand the clinical value of measuring cardiac troponin at previously immeasurable levels in blood and discovered that high sensitivity cardiac troponin assay methods could be used to determine a particular individual’s risk for developing or having cardiovascular disease. It has also become clear that the new generation of high sensitivity cardiac troponin assays are an improvement over previous generation assays for ruling in and out the presence of a myocardial infarct, or heart attack.

“We are especially pleased about this new patent as it further secures our pioneering work of using ultrasensitive troponin immunoassays to better diagnose the presence or absence of heart attacks in patients presenting to hospital Emergency Departments,” said Guido Baechler, President and Chief Executive Officer of Singulex. “It also adds to our comprehensive global IP portfolio which includes patents that claim any high sensitivity method for measuring cardiac troponin and hence assessing the presence or absence of cardiovascular disease.”

Heart disease is the number one cause of death in the world today.1 Due to the acute nature and rapid progression of heart disease, accurate and quantitative diagnostic assays have been developed to detect the presence of clinically proven biomarkers. As technologies progressively improve and mature, biomarkers, such as cardiac troponin, are becoming critical tools in the clinical diagnosis of acute myocardial infarction. It is estimated that the worldwide cardiac troponin market will reach $2.3 billion by the end of 2018 and grow to $3.6 billion by 2022.2

About Singulex

Singulex is a commercial stage in vitro diagnostics 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. The Singulex Clarity system and Singulex Clarity cTnI assay have the CE mark and are commercially available in Europe. High sensitivity assays for measuring C. difficile toxins A/B are CE marked in the EU and registered with the FDA for use on the Clarity system. 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 singulexclarity.eu.

1 Emelia J. et al, Heart Disease and Stroke Statistics-2018 Update: A Report from the American Heart Association. Circulation 2018; 137:e67-e49234

2 Cardiac Biomarkers: Technologies and Global Markets 2018, BBC Research Wellesley MA

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Last Updated: 12-Dec-2018