Critical Diagnostics
A Novel In vitro Diagnostic Test for Heart Failure Patient Management

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.

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

With the help of ST2, clinicians can be more precise in providing care that slows down the progression of cardiac disease. Along with improving the quality of care, the availability of a blood test like the Presage ST2 Assay from Critical Diagnostics’ that accurately measures ST2 also helps to curtail hospital costs and optimizes patient outcomes.

Leveraging Critical Diagnostic’s ST2 test as a part of patient management program, healthcare institutions can reduce rehospitalization of patients with heart failure. The tool helps clinicians to determine the severity of patients’ condition accurately before hospitalization. “Using ST2, healthcare organizations can potentially decrease hospitalizations and read missions, and improve the overall patient care,” adds Snider.

To exemplify the capability of Critical Diagnostics’ ST2 testing tool, Snider cites an anecdote of a patient suffering from severe heart failure. Failing to respond to prescribed medications, the patient’s doctor recommended costly heart transplantation. However, the patient was referred to a cardiologist who specializes in heart failure and by using the Presage^® ST2 Assay the new cardiologist had a clearer picture of the patients disease status. The ST2 result confirmed that the patient was not as severely sick as thought and had been prescribed the wrong class of drugs. Finally, through more effective polypharmacy, the cardiologist was able to rebalance the situation and stabilize the patient. The patient’s condition improved without having to undergo heart transplantation.

Moving forward, Critical Diagnostics anticipates continued growth of its footprint globally, including emerging markets like China and India. Along the path of product expansion, in addition to the quantitative lateral flow product branded the Aspect-Plus™ ST2 Test available under CE mark, the company is developing an automated assay to measure ST2 on the standard chemistry assay instruments.