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SAN DIEGO, CA March 17, 2015 – Critical Diagnostics reported today that The American Journal of Cardiology released an online version of a comprehensive consensus paper discussing the evidence base behind the evolving role of the cardiac biomarker ST2 and its appropriate uses in the management of patients with heart failure and related cardiac diseases.

“Given the rapid rise in scientific reports discussing ST2 and heart disease, we felt it appropriate to propose an international working group focused on appropriate use of ST2 across a wide range of topics,” note the paper’s leader authors, James L Januzzi, MD, PhD, Division of Cardiology, Massachusetts General Hospital, Boston, MA., and Antoni Bayes-Genis,MD, PhD , Department of Cardiology, Hospital universitari Germans Trias i Pujol.

The paper stems from an International ST2 Consensus Panel of experts from around the world that gathered in March 2014 in Washington, DC., to discuss and update the rising number of studies focused on the use of ST2.

As the authors point out, “Despite the well-documented successes and strengths of natriuretic peptides, there is plenty of room for improvement in the way we evaluate and risk-stratify patients with or at risk for HF using biomarkers. Although a large number of candidate biomarkers have been evaluated to help fill this gap, few have survived the rigorous studies that are a prerequisite to allow for translation into the clinical realm[1],[2]. It now appears clear that ST2 (reflecting myocardial fibrosis and remodeling) is a biomarker that has successfully navigated this course and is recently emerging as a reliable tool for patient care.

“The recent 2013 AHA/ACC Guidelines for the Management of Heart Failure give a recommendation for the measurement of ST2 in acute and ambulatory HF patients, noting that ST2 is not only predictive of hospitalization and death in patients with HF, but is also additive to the natriuretic peptides in its prognostic value[3]. The body of evidence surrounding ST2 in both acute and chronic heart failure is growing rapidly, and with this, its clinical use has increased.[4]

To access to the paper, go to: http://www.ajconline.org/issue/S0002-9149(15)X0003-8

Heart failure is a condition in which the heart can't pump enough blood to meet the body's needs. As noted by Professor Eugene Braunwald in “The War Against Heart Failure,” in The Lancet,[5] Heart failure is a global problem with an estimated prevalence of 38 million patients worldwide, and a number that is increasing with the aging of the population. Heart failure is the most common diagnosis in patients aged 65 years or older admitted to hospital. Despite some progress, the prognosis of heart failure is worse than that of most cancers.

ST2 is a soluble protein expressed by the heart in response to disease or injury. It is reflective of ventricular remodeling and cardiac fibrosis associated with heart failure. ST2 is not adversely affected by confounding factors such as age, body mass index and impaired renal function. Unlike many other cardiac biomarkers, ST2 levels change quickly in response to changes in the patient’s condition—thus helping physicians make informed decisions on an appropriate course of action to take and, if needed, to quickly adjust treatment. Since 2013 there have been over 400 scientific papers and abstracts published on ST2[6].

Critical Diagnostics (www.criticaldiagnostics.com) develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs.

Dennis Dalangin, VP Marketing
Telephone: +1 (877) 700-1250
Email: ddalangin@criticaldiagnostics.com

[1] Ahmad T, Fiuzat M, Pencina MJ, Geller NL, Zannad F, Cleland JG, Snider JV, Blankenberg S, Adams KF, Redberg RF, Kim JB, Mascette A, Mentz RJ, O'Connor CM, Felker GM, Januzzi JL. Charting a Roadmap for Heart Failure Biomarker Studies. JACC Heart failure 2014.
[2] van Kimmenade RR, Januzzi JL, Jr. Emerging biomarkers in heart failure. Clinical chemistry 2012;58:127-138.

[3] Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE, Jr., Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL, American College of Cardiology F, American Heart Association Task Force on Practice G. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology 2013;62:e147-239.
[4] The Presage ST2 Assay is CE Marked. In the U.S. the Presage assay is FDA cleared for risk stratification in Chronic Heart Failure patients.
[5] Published online November 16, 2014
[6] Based on PubMed.com listings.