Critical Diagnostics Announces Growing Body of Research into Cardiac Biomarker ST2 Offers Great Promise in the Care of Heart Failure and Heart Attack Patients.

NEW YORK -- Critical Diagnostics today announces the publication of two important research papers further refining the clinical value and mortality prediction power of the cardiac biomarker ST2. On April 1, 2008 the research paper, "Increased Plasma Concentrations of Soluble ST2 are Predictive for 1-Year Mortality in Patients with Acute Destabilized Heart Failure" was published in the journal Clinical Chemistry, (www.aacc.org), and on April 15, 2008 the research paper "Complementary Roles for Biomarkers of Biomechanical Strain ST2 and N-Terminal Prohormone B-Type Natriuretic Peptide in Patients with ST-Elevation Myocardial Infarction" was published in the journal Circulation, (http://circ.ahajournals.org). The result of these latest studies is to confirm the clinical value of ST2 in the two cardiovascular diseases impacting the most patients, acute destabilized heart failure (ADHF) and myocardial infarction (MI).

The April 1 paper describing the prognostic strength of ST2 in patients diagnosed with ADHF provides an independent validation of the work published in August of 2007 in The Journal of the College of Cardiology, "Measurement of the Interleukin Family Member ST2 in Patients with Acute Dyspnea: Results from the ProBNP Investigation of Dyspnea in the Emergency Department (PRIDE) Study." The just-published study analyzed a cohort of 137 patients diagnosed with ADHF from a total population of 251 patients who presented with dyspnea. This study unequivocally establishes that ST2 independently predicts mortality and provides the most accurate prediction of mortality, exceeding the mortality predictive values of natriuretic peptide biomarkers, such as BNP. First author on this paper, Dr. Thomas Mueller of the Konventhospital Barmherzige Brueder in Linz, Austria adds, "It can be derived from our data that ST2 seems to be an excellent marker for risk stratification in patients with acute destabilized heart failure providing prognostic information being stronger than other traditional risk factors, such as age or renal dysfunction. Thus, ST2 determination might offer significant value in helping physicians in cardiac patient care in the emergency department."

The second paper, produced by the TIMI Study Group at Brigham and Women's Hospital in Boston, analyzed a large cohort of 1239 patients with STEMI who underwent coronary angiography. This study concluded that in contrast to NT-proBNP the baseline level of ST2 strongly predicted risk of cardiovascular death or heart failure and was independent of clinical factors potentially related to increased left ventricular wall stress, such as age, hypertension, prior MI and prior heart failure. Lead author of this paper, Dr. Marc Sabatine comments, "Measurement of ST2 provides significantly improved risk prediction in patients with acute myocardial infarction, beyond traditional clinical risk factors and existing biomarkers such as NT-proBNP." The study went on to report that, as had been observed in earlier studies, although NT-proBNP and ST2 are independent biomarkers for prediction of mortality there is a complementary value in using the markers together.

Cardiovascular disease is the leading cause of death in the US and the incidence of heart failure, as a form of cardiovascular disease, is increasing. The research described in these papers confirms that ST2, which is a mechanically-induced cardiovascular protein, is a powerful and accurate biomarker for prediction of near term mortality in ADHF as well as MI patients. "Determination of disease severity in patients with acute cardiovascular disease, such as heart failure or myocardial infarction, is particularly challenging for physicians with the tools available to them today," comments Critical Diagnostics President James V. Snider, Ph.D. adding, "The results described in these research papers confirm the potential clinical value of ST2 as a risk stratification and disease severity determination biomarker for patients with cardiovascular disease."

About Critical Diagnostics

Critical Diagnostics (www.criticaldiagnostics.com) is the exclusive developer of the Presage[TM] laboratory assays employing ST2 for the diagnosis and prognosis of cardiovascular disease1. Critical Diagnostics was founded in 2004 and is funded by Carrot Capital Healthcare Ventures (CCHV) of New York. CCHV focuses on promising seed- and early-stage investment opportunities across a broad spectrum of the healthcare industry.

1Presage and assays employing ST2 are not currently approved by the FDA for clinical use and are not available for sale in the US for clinical use.