According to the company, the product is indicated for use as an aid in risk stratification of patients with heart failure or acute coronary syndrome. This regulatory milestone marks the first time that an assay has become commercially available for the clinical measurement of the biomarker soluble ST2.

The use of ST2 as a risk stratification tool has been studied to date in more than 20,000 patients and presented in over thirty peer-reviewed papers and publications.

Critical Diagnostics develops products to help physicians optimize patient care in cardiovascular diseases, such as heart failure. The high sensitivity Presage ST2 Assay measures the level of ST2 in blood, identifying patients at increased risk of morbidity and mortality.

ST2 signals the presence of adverse cardiac remodeling and fibrosis, which occurs in response to myocardial infarction (MI), ischemia, or worsening heart failure, said Critical.

Remodeling and fibrosis can also contribute to the development of future adverse events, such as secondary MI or sudden cardiac death , and to progression of heart failure.

The Presage ST2 Assay helps clinicians assess patient prognosis in order to better personalize their care. By selecting the most appropriate treatments and interventions for each patient, a physician can maximize the clinical benefit from increasingly limited healthcare resources.

The Presage ST2 Assay is not available for sale in the US, pending FDA clearance.

Pat Arensdorf, CEO of Critical Diagnostics, said: “The high sensitivity measurements of ST2 enabled by our assay have been consistently proven to provide new prognostic information to clinicians on the future health status of their cardiovascular patients, providing insight into novel biology regarding fibrotic and cardioprotective disease processes not available from other cardiovascular biomarkers.

“We are pleased that the Presage ST2 Assay will now help European physicians optimize their care for this large and growing group of high-risk patients. Furthermore, it is our hope that with better risk stratification tools, physicians can more efficiently manage medical resources required by these important patients and reduce overall healthcare system costs.”

Can the company successfully market the tool in Europe?

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