Superiority of Cardiac Biomarker ST2 over Natriuretic Peptide Markers and Galectin-3 Featured In YouTube Video

Critical Diagnostics, makers of the Presage® ST2 Assay, announced today that a videotaped lecture by noted cardiologist James Januzzi, Jr., MD, Associate Professor of Medicine at Harvard Medical School and Director, Cardiac Intensive Care Unit at Massachusetts General Hospital, discussing his views and opinions regarding the powerful role of the cardiac biomarker ST2 in shifting the paradigm in the management of heart failure patients, has been posted on YouTube for immediate viewing.

The 47-minute video is a culmination of the clinical and research evidence surrounding ST2 in predicting heart failure above and beyond existing biomarkers, including BNP from Alere (NYSE:ALR), Roche Diagnostics’ NT-proBNP (OTCQX: RHHBY) and Galectin-3 from BG Medicine (NASDAQ:BGMD). Dr. Januzzi highlights the current gaps in the clinical management of heart failure patients and, from his experience, provides medical scenarios where ST2 can make an immediate impact in directly influencing care and management of heart failure patients, potentially reducing healthcare costs and risk of adverse outcomes.

“We have done a lot of work to evaluate ST2 and have unequivocal evidence that ST2 adds and supersedes, actually, the natriuretic peptides for multiple applications,” Dr. Januzzi stresses in his lecture. “We examined a number of different biomarkers, including ST2, relative to their ability to prognosticate . . . not a single one was even close to the value of ST2 for prognosis . . . ST2 has been shown to be of value across all four stages of heart failure.

“In the [HF-ACTION] study, Galectin-3 appeared to be prognostically meaningful when it was placed in an unadjusted model, but the moment either NT-proBNP or renal function was entered into the model, Galectin-3 fell out. In contrast, ST2 survived adjustment for both NT-proBNP and renal function, maintaining its prognostic power. ST2 is independent of renal function, body mass index and a number of relevant covariates.

“The real question now is, can we harness this utility [of ST2] for prognosis to improving outcomes for patients? That is the goal. In PROTECT, a chronic ambulatory treatment study, we measured ST2 values at each visit and assessed its ability to predict risk from visit to visit, and in addition examined what an elevated ST2 value meant in this context relative not only to outcomes, but relative to changes on these patients’ echo cardiograms and ultimately their treatments. ST2 changed considerably, very much in parallel with the clinical picture that these patients presented visited with . . . unlike other biomarkers like Growth Differentiation Factor 15 (GDF-15), highly-sensitive troponin and Galectin-3.

“ST2 has been shown to be of value across all four stages of heart failure . . . It has been shown repeatedly that ST2 reclassifies risk above and beyond other biomarkers, suggesting that it provides unique biological information to tests we already have.”

“This engaging video lecture is proof of the pathway ST2 is paving in revolutionizing care for heart failure patients,” notes Dr. James Snider, President of Critical Diagnostics. “We concur with Dr. Januzzi when he says, ‘this biomarker is here to stay and will be used in a wide range of patients, heart failure as well as others.’”

The video can be viewed on YouTube under ST2 Cardiac Biomarker, or by using this link: http://www.youtube.com/watch?v=3IHjVGaW-Fo

About ST2

Soluble ST2 has now been published in more than 100 peer-reviewed articles and scientific posters studying more than 35,000 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.

About Critical Diagnostics

Critical Diagnostics (www.criticaldiagnostics.com) 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.