HDL to offer testing services based on Critical Diagnostics' Presage ST2 Assay

Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases and Health Diagnostic Laboratory, Inc. (HDL, Inc.), announced today an agreement under which HDL, Inc. will soon offer ST2 testing services based on Critical Diagnostics' Presage® ST2 Assay. The Presage ST2 Assay was recently cleared by the U.S. Food and Drug Administration for use in assessing the prognosis of patients diagnosed with chronic heart failure.

Heart failure is a 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. According to the American Heart Association, heart failure affects some 5.8 million Americans with 670,000 new diagnoses each year. The estimated direct and indirect cost of this condition in the US is $39.2 billion.  

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. Presage ST2 Assay levels are independent and complimentary of natriuretic peptide markers and not adversely affected by such confounding factors as age, gender, body mass index and impaired renal failure.

"Novel biomarkers, such as the Presage ST2 Assay, allow physicians to select the most appropriate treatments and interventions for each patient, thus maximizing the clinical benefit from increasingly limited healthcare resources," said Tonya Mallory, CEO and co-founder of Virginia-headquartered HDL, Inc. "We're dedicated to helping physicians improve patient care, and the addition of Presage ST2 to our test menu supports this mission."

"We are very excited about our association with HDL, Inc., a leading specialty clinical reference laboratory with a cardiovascular focus," said James Snider, President of Critical Diagnostics. "Through this association thousands of physicians will have access to the Presage ST2 Assay very quickly."