FDA clears Presage ST2 assay for cardiovascular disease

18 December 2011 (Last Updated November 22nd, 2018 11:19)

US-based biomarker company Critical Diagnostics has received US Food and Drug Administration (FDA) approval for its Presage ST2 assay, which is used to help determine the prognosis of patients diagnosed with chronic heart failure.

US-based biomarker company Critical Diagnostics has received US Food and Drug Administration (FDA) approval for its Presage ST2 assay, which is used to help determine the prognosis of patients diagnosed with chronic heart failure.

The assay quantitatively measures the level of ST2 in the blood. ST2 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.

Critical Diagnostics president James Snider said with the use of the Presage ST2 assay, physicians can assess patient prognosis, providing better personalise care

''Starting next year, the Centers for Medicare and Medicaid Services is instituting a new compensation policy addressing readmission,'' Snider said.

According to the Centers for Disease Control, more than one million people in the US are admitted to an inpatient setting for heart failure a year, costing Medicare $17.4bn annually.

Duke University School of Medicine Division of Cardiology associate professor of Medicine Michael Felker said ST2 will generate accurate prognostic information for patients diagnosed with chronic heart failure.

"In the future, there is hope that a better understanding of prognosis using markers like ST2 can help us guide therapy and ultimately improve outcomes in heart failure patients," Felker said.

Critical Diagnostics chairman David Geliebter said the Presage ST2 assay is now available to assist critically ill heart failure patients in both Europe and the US.

The ST2 assay as a risk stratification tool has been studied in more than 20,000 patients, and it has been demonstrated that ST2 has prognostic value that adds new information over and above that provided by other biomarkers.

Critical Diagnostics develops novel diagnostics to help physicians optimise patient care in cardiovascular diseases, while containing healthcare costs.