US-based biomarker company Critical Diagnostics has announced that Hospital Germans Trias i Pujol in Barcelona, Spain, is using its Presage ST2 assay for routine care and management of heart failure patients.
The US Food and Drug Administration approved and CE marked Presage ST2 assay quantitatively measures the level of ST2 in blood, identifying patients at increased risk of morbidity and mortality.
The assay is used to aid risk stratification of patients with heart failure or acute coronary syndrome, and also signals the presence of adverse cardiac remodelling and fibrosis, which occurs in response to myocardial infarction, ischaemia or worsening heart failure.
Critical Diagnostics president James Snider said the Presage ST2 assay helps health care providers assess patient prognosis in order to better personalise their care.
"By selecting the most appropriate treatments and interventions for each patient, a physician can maximise the clinical benefit from increasingly limited healthcare resources," Snider added.
Hospital Germans Trias i Pujol cardiology service head Antoni Bayes-Genis said that its data indicates that the assay refines the prognosis and allows staff to isolate patients who will evolve poorly from those who are likely to have a good outcome.
"Different groups worldwide are working together to study the role of ST2 in humans and our hospital is the first to apply it in day-to-day operation using the marker in the context of routine care for our patients," Bayes-Genis said.
"We now have a second generation of heart failure markers. The first generation were the natriuretic peptides. But we are seeing that ST2 is a marker as powerful or more than natriuretic peptides for predicting death.”
The Presage ST2 assay was validated in the Global Use of Strategies To Open Occluded Coronary Arteries (GUSTO) IV trial, conducted at multiple Swedish sites. It found that the assay would be a powerful tool for doctors in the risk-stratification of cardiovascular patients, in particular those with non-ST segment elevated acute coronary syndrome (NSTE-ACS).
The study also demonstrated that ST2 levels measured soon after hospital admission predict one-year mortality outcomes in patients diagnosed with NSTE-ACS.