An estimated six million people are living with heart failure in the United States. The magnitude of this health problem is reflected in the significant cost on the global healthcare system, which, to put it in perspective, is equivalent to the combined economic burden that is imposed by all forms of cancer. “Unfortunately, the high re-admission rates for heart failure is an indication that the current clinical management for these patients is inadequate,” reveals Dennis Dalangin, CEO at Critical Diagnostics. To improve management of patients suffering from heart failure, one option available to clinicians is testing for the cardiac biomarker ST2. It is a soluble protein present in the blood stream that can help assess the risk of an adverse outcome and severity of adverse cardiac events in patients who have had a myocardial infarction (MI) or have heart failure. Prior to the development of the ST2 test, these evaluations were done through subjective clinical assessments, or by utilizing diagnostic biomarker tests such as cardiac troponin or BNP. Today, with the help of biomarkers, such as ST2, physicians can assess the physiological status of the patient’s disease, personalize treatment options, and better guide in-hospital, post-discharge and outpatient care.

With the aim to optimize patient care for cardiovascular diseases, San Diego-based Critical Diagnostics has developed a high sensitivity in-vitro diagnostic tool, the Presage ST2 Assay, which is the industry’s only FDA cleared test to quantitatively measure soluble ST2 in plasma or serum. The test follows a standard blood analysis laboratory protocol and provides physicians with an accurate ST2 result that can be used to clinically assess the physiological status of a patient’s heart. “ST2 provides objective evidence about a patient’s disease, identifies patients at increased risk of adverse events, and what therapies the patient is likely to respond or not respond,”notes James Snider, President and Chief Scientific Officer.