Critical Diagnostics‘ Presage ST2 assay has demonstrated positive results in predicting sudden cardiac death in ambulatory chronic heart failure patients in a multicentre trial.

The Penn Heart Failure Study (PHFS), a multicentre cohort of 1,513 outpatients with chronic heart failure, used a panel of seven biomarkers including ST2 as measured using the Presage ST2 assay, and compared results to the Seattle Heart Failure Model (SHFM).

The study found that patients in the highest one-third of the multimarker score had a 13.7-fold increased risk of adverse outcomes compared to the lowest one-third, and the risk remained nearly seven-times higher after adjustment for the SHFM.

The Presage ST2 test quantitatively measures the level of ST2 in blood that has been shown to be a predictor of mortality as well as all-cause hospitalisation, mortality due to cardiovascular disease and hospitalisation due to cardiovascular disease.

ST2 signals the presence of adverse cardiac remodelling and fibrosis, which occurs in response to myocardial infarction (MI), ischemia or worsening heart failure.

Critical Diagnostics president James Snider said the study provides continued support for the value of the Presage ST2 assay in risk-stratifying patients with heart failure to better manage their condition.

Critical Diagnostics, a biomarker company, develops novel biomarkers to help physicians optimise patient care in cardiovascular diseases, while containing healthcare costs. Assay levels are independent and complimentary of natriuretic peptide markers and not adversely affected by factors such as age, gender, body mass index or impaired renal failure.

The Presage ST2 assay has been cleared by the US Food and Drug Administration and European Commission for use as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.