Market Overview

Next Generation Cardiac Biomarker From Critical Diagnostics Accurately Predicts Risk of Heart Failure in The General Population


Critical Diagnostics, makers of the Presage® ST2 Assay, announced today that during a presentation at the American Heart Association Scientific Sessions in Los Angeles, the results of a study conducted through the Mayo Clinic and Foundation, Plasma Levels of ST2 in the Community: Association with cardiac remodeling, heart failure incidence and mortality, highlighted the remarkable accuracy of ST2 in predicting the risk of heart failure and mortality in the general population.

The study of 1831 healthy individuals from Olmsted County, Minnesota was designed to determine whether elevated levels of ST2 in otherwise healthy people could predict those at increased risk for the development of heart failure. Study participants were followed for approximately a decade and ST2 levels were measured using the Presage ST2 Assay. The results were impressive. Individuals with elevated ST2 concentrations were more than 2 times as likely to develop heart failure or to die over this period of time.

Furthermore, the prognostic strength of ST2 endured even after adjustment for all the variables commonly associated with outcomes, including the generally accepted prognostic biomarkers C reactive protein (CRP) and NT-proBNP.

“This report from the Olmsted County cohort confirms the results from a separate study by the Framingham Heart Study, under the direction of the National Heart, Lung and Blood Institute and Boston University. That study was the first to show that seemingly healthy individuals with higher ST2 levels are at significant risk of developing heart failure well before the onset of any symptoms,” notes Dr. James Snider, President of Critical Diagnostics. “In primary disease prevention, ST2 provides a powerful new tool for the medical community to provide personalized care through the use of early detection and treatment strategies.”

Other ST2-related presentations during the AHA Scientific Sessions include “Serial Changes in ST2 are Superior to Other Biomarkers in the Prediction of Adverse Events in a Cohort of Ambulatory Chronic Heart Failure Patients,” presented by Dr. Amy K. Saenger, “ST2 and NT-proBNP are Associated with Cardiac Dysfunction and Mortality in HIV-Infected Individuals,” presented by Dr. Eric A. Secemsky, “Interleukin-33 and Soluble ST2 Are Expressed in Human Nonrheumatic Aortic Valve Stenosis,” presented by Dr. Hisashi Sawada, “Soluble St2 is Regulated By P75NTR and Predicts Mortality in Diabetic Patients With Critical Limb Ischemia,” presented by Dr. Andrea Caporali, and “Interleukin-33 Serum Levels After Coronary Stent Implantation Predict In-Stent Restenosis,” presented by Dr. Walter S. Speidl.

About ST2

Soluble ST2 has now been published in more than 50 peer-reviewed articles studying more than 31,000 patients. These clinical studies have demonstrated that high levels of soluble ST2 are predictive of adverse patient outcomes and death in a broad spectrum of cardiovascular disease. They have further shown that the prognostic information from soluble ST2 is independent of, and provides added information to, that of cardiac biomarkers commonly used today, including the natriuretic peptides BNP and NT-proBNP.

About Critical Diagnostics

Critical Diagnostics ( develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs. The Presage ST2 Assay has been CE Marked and cleared by the US FDA for use in risk stratification with chronic heart failure patients. Critical Diagnostics has exclusive worldwide rights to ST2 for the diagnosis and prognosis of cardiovascular disease.

Critical Diagnostics
Dennis Dalangin, 877-700-1250
VP Marketing

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