SAN DIEGO--(BUSINESS WIRE)--Critical Diagnostics announced today, Circulation, an American Heart Association Journal, released online the first study evaluating the power of ST2 to predict development of heart failure and other adverse outcomes in the general population titled, “Prognostic Utility of Novel Biomarkers of Cardiovascular Stress: The Framingham Heart Study”.

The Framingham Heart Study Cohort evaluated over 3,400 individuals to determine the prognostic utility of ST2 individually, and when combined with other biomarkers, to predict heart failure and other adverse events in people who are not medically perceived to be at risk. The study participants were followed for an average of just over 11 years.

As the study authors note, “sST2 [soluble ST2] is an emerging biomarker that has been shown to predict adverse outcomes and death in individuals with established heart failure.” The inclusion of ST2, a unique marker for cardiac remodeling and fibrosis, makes this study “the first to examine the prognostic value of sST2 measurements in the general population, showing that higher levels of circulating sST2 (comparable to those found in hospitalized patients) can be detected in apparently healthy individuals and precede adverse outcomes.”

When ST2 was used individually in the study as a marker of risk in fully adjusted statistical models, elevated levels resulting in heart failure or death were 45% and 32% greater respectively.

To put that into perspective, a contemporary analysis from the same study cohort recently reported that elevations of galectin-3, a biomarker offered by BG Medicine (NASDAQ: BGMD), had associated likelihood of heart failure or death of only 23% and 15% greater respectively.

Comparing the results, then, ST2 had twice the predictive value for heart failure or death of galectin-3. Moreover, when galectin-3 values were adjusted for kidney function, the association with incident heart failure was not statistically relevant.

When the study group measured soluble ST2, growth differentiation factor-15, high-sensitivity troponin I, hsCRP and BNP as a multi-marker panel in the 3,428 participants, individuals with scores in the highest quartile had a 3-fold higher risk of death, 2-fold higher risk of cardiovascular events, and a 6-fold higher risk of heart failure. Again, by comparison, that is three times the predictive value for heart failure as galectin-3. The multimarker score was also superior to a model containing current standard-of-care cardiac biomarkers hsCRP, BNP, and clinical risk factors.

Among the individuals in the study who were initially classified as low risk with existing clinical methods but later developed heart failure, by using ST2 as the measurement of risk, 36% were re-classified to high risk, while another 21% who were classified as low risk using existing clinical methods, but later died, were up-classified under guidelines based on ST2 measurements. As the study then shows, proper classification of patients using ST2, may result in significantly improved outcomes for such individuals.

“ST2 has been shown repeatedly to be an extremely robust cardiac biomarker in assessing risk of adverse outcomes in patients with heart failure. It has now been shown to be a strong predictor of incident heart failure in asymptomatic individuals as well,” says Critical Diagnostics President James Snider. “And, unlike other biomarkers in use today, interpretation of ST2 results is not compromised by common clinical confounders, such as impaired renal function, age, sex, smoking, body mass index, and conventional cardiovascular risk factors, making the Presage ST2 Assay more generally applicable for routine clinical use.”

“The potential impact in clinical care from these results is compelling,” states David Geliebter, CEO of Critical Diagnostics, makers of the Presage ST2 Assay. “The study findings support the concept that cardiovascular dysfunction or injury can exist for many years before the onset of overt disease in otherwise healthy individuals, and as importantly, confirm that with conventional clinical methods alone, a measurable percentage of people are not receiving optimal care to reduce progression of cardiovascular disease such as heart failure.”

“The evidence for the clinical utility of ST2 in predicting heart failure continues to build,” notes Snider. “The most recent release of data further supports ST2’s position in filling the prognostic gap in heart failure management. As this study demonstrates, deployment of a primary disease prevention program in the general population can aid in the development of proactive strategies to delay or possibly prevent onset of cardiovascular disease. This is the future of medicine.”

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 the Framingham Heart Study

The Framingham Heart Study, was formed in 1948 – under the direction of National Heart, Lung, and Blood Institute (NHLBI) – to investigate the development of cardiovascular diseases in a longitudinal study that involve researching key elements that may provide insight in the prevention and progression of cardiovascular diseases, which afflicts some 82 million Americans.

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.