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Critical Diagnostics Presage ST2 assay obtains CE mark

Critical Diagnostics, which develops products to help physicians optimize patient care in cardiovascular diseases, has received CE mark to commence commercialization of its sensitivity Presage ST2 assay in Europe.

The Presage ST2 assay is indicated for use as an aid in risk stratification of patients with heart failure or acute coronary syndrome for the clinical measurement of the biomarker soluble ST2..

Critical Diagnostics CEO Pat Arensdorf said CE mark is a further validation of their Presage ST2 Assay, and comes after extensive clinical studies.

"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," Arensdorf said.

"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 and 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 health care system costs."