SAN DIEGO, Calif.--(BUSINESS WIRE)--Critical Diagnostics announced today that the American College of Cardiology Foundation/American Heart Association Task Force jointly released its expanded clinical practice guideline for the management of patients with heart failure and has identified ST2 “not only predictive of hospitalization and death in patients with HF [heart failure] but also additive to natriuretic peptide levels in [its] prognostic value.”
The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have jointly produced guidelines in the area of cardiovascular disease since 1980. The guidelines are designed to assist clinicians in selecting the best management strategy for heart failure patients, and have been adopted by most U.S. cardiologists and followed by many other countries in developing their practice guidelines.
“Having ST2 included in the 2013 ACC/AHA Guidelines is unprecedented,” notes David Geliebter, CEO of Critical Diagnostics. “We only received FDA clearance in December of 2011. No cardiac biomarker that we know of has ever achieved this acceptance so quickly.”
About ST2
ST2 is a member of the interleukin (IL)-1 receptor family, whose expression in cardiomyocytes is upregulated in response to stress. The membrane-bound form of ST2 interacts with IL-33 (released from fibroblasts), leading to anti-hypertrophic and anti-fibrotic effects in the myocardium. Soluble ST2 (sST2) consists of the extracellular domain of the ST2 molecule, and may act as a decoy receptor for IL-33, blocking myocardial and vascular benefits, experimentally leading to progressive myocardial remodeling and atherosclerosis, respectively. In in vivo studies, infusion of large amounts of soluble sST2 results in adverse cardiac remodeling, heart failure, and premature death. Clinical studies have further shown that the prognostic information from sST2 is independent of, and provides added information and value to, that of cardiac biomarkers commonly used today.
sST2 has been published in more than 100 peer-reviewed articles and scientific posters studying more than 40,000 patients. Critical Diagnostics holds numerous issued and pending international patents on ST2. The Presage® ST2 Assay from Critical Diagnostics is the only commercially available ST2 biomarker in the world. The Presage ST2 Assay has been CE Marked and cleared by the U.S. FDA for use as in the risk stratification of chronic heart failure patients.
About Critical Diagnostics
Founded in 2004, Critical Diagnostics (www.criticaldiagnostics.com) develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs. Critical Diagnostics has distribution partners for its Presage ST2 Assay in 45 countries, covering two-thirds of the world’s population.
