Critical Diagnostics receives FDA clearance for Presage ST2 Assay

Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases, announced today that the U.S. Food and Drug Administration has cleared the company's Presage® ST2 Assay for use as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

Heart failure is a chronic, progressive disease in which the ability of the heart to provide needed cardiac output weakens, thus impeding the heart's ability to pump enough blood to support the body's metabolic demands. The prevalence of heart failure is growing worldwide and is a major burden on hospital care costs. According to the Centers for Disease Control, over one million people in the U.S. are admitted to an inpatient setting for heart failure annually. In fact, heart failure is the leading cause of hospitalizations for people over 65 years of age. Unplanned readmissions cost Medicare $17.4 billion a year.

The Presage® ST2 Assay quantitatively measures the level of ST2 in blood. ST2 has been shown to be a significant predictor of mortality as well as all-cause hospitalization, mortality due to cardiovascular disease, and hospitalization due to cardiovascular disease. ST2 is prognostic for clinically important outcomes in addition to all-cause mortality.

"Starting next year, the Centers for Medicare and Medicaid Services is instituting a new compensation policy addressing readmission," notes James Snider, President of Critical Diagnostics. "Hospitals with higher rates of risk-adjusted all-cause rehospitalizations will receive lower reimbursement."

ST2 and natriuretic peptides, such as NT-proBNP, are measures of separate and distinct biological processes. ST2 and natriuretic peptides provide independent and complementary prognostic information.

"Through the use of the Presage ST2 Assay, clinicians can assess patient prognosis with the hope of being able to better personalize care," says Snider.

"ST2 is a very important advance in our ability to provide accurate prognostic information for patients diagnosed with chronic heart failure," states G. Michael Felker, MD, MHS, Associate Professor of Medicine, Division of Cardiology, Duke University School of Medicine. "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."

"This latest regulatory milestone follows the granting earlier this year of a CE (Conformité Européenne) Mark in Europe," says David Geliebter, Chairman of Critical Diagnostics. "We are very gratified that the Presage ST2 Assay is now available to assist critically-ill heart failure patients in both Europe and the United States."

Source: Critical Diagnostics