FDA gives go-ahead to ST2 biomarker assay

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Critical Diagnostics' Presage ST2 Assay, a cardiac biomarker assay that can be used in the prognosis of patients with chronic heart failure, was cleared by the FDA Dec. 15.

The prognostic tool, which measures soluble ST2 levels in blood, received CE mark in Europe earlier this year.

ST2 is a cardiac biomarker that has been shown to be associated with adverse cardiac remodeling and fibrosis, the company stated. Its presence may indicate MI, ischemia or worsening heart failure.