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FDA Clears Critical Diagnostics Presage ST2 Assay for Patients with Heart Failure

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Critical Diagnostics is a U.S.-based biomarker company focused on optimizing patient care in cardiovascular diseases, such as heart failure. The San Diego-based company announced yesterday that they have received FDA approval for their Presage ST2 Assay for use as an aid in assessing the prognosis of patients diagnosed with chronic heart failure [1].

The Presage ST2 Assay quantitatively measures the level of ST2 (a.k.a. interleukin 1 receptor-like 1 (IL1RL1) or IL33R) 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. Importantly, ST2 is prognostic for clinically relevant outcomes in addition to all-cause mortality. ST2 also represents a novel mechanism of intramyocardial fibroblast-cardiomyocyte communication that may prove to be a therapeutic target for the prevention of heart failure [2].

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 supply sufficient blood flow to meet the needs of the body. The prevalence of heart failure is growing worldwide and is a major burden on hospital care costs. Annually, over one million people in the U.S. are admitted to an inpatient setting for heart failure.

And it’s not just the elderly anymore. In the past three decades, adults younger than 65 years have experienced a higher relative increase in heart failure hospitalization rates than the elderly. Despite emphasis by healthcare facilities on heart failure management, unplanned readmissions cost Medicare $17.4 billion a year, and HF is the most frequent reason for rehospitalizations [3].

According to James Snider, President of Critical Diagnostics [1]:

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

David Geliebter, Chairman of Critical Diagnostics, said [1]:

This latest regulatory milestone follows the granting earlier this year of a CE (Conformité Européenne) Mark in Europe. 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.


  1. FDA Clearance for Presage ST2 Assay for Patients with Heart Failure. Critical Diagnostics press release. 2011 Dec 15.
  2. Kakkar and Lee. The IL-33/ST2 pathway: therapeutic target and novel biomarker. Nat Rev Drug Discov. 2008 Oct;7(10):827-40.
    View abstract
  3. Jencks et al. Rehospitalization among patients in Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28.
    View abstract