Presage® ST2 Assay for Assessing Cardiovascular Disease to Be Distributed Throughout Europe

Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases, today announced that it has signed agreements with four new European distributors in Germany, Spain, France and Turkey to distribute the Presage ST2 Assay.

ST2 (growth STimulation expressed gene 2) is a member of the interleukin 1 receptor family. The ST2 protein has two isoforms directly implicated in the progression of cardiac disease. The Presage® ST2 Assay quantitatively measures the concentration of soluble ST2, providing a physician with an accurate tool to assess prognosis in patients with cardiovascular disease.

The Presage ST2 Assay has been CE Marked and cleared by the US FDA for use in risk stratification with chronic heart failure patients. Critical Diagnostics has exclusive worldwide rights to ST2 for the diagnosis and prognosis of cardiovascular disease.

"Just recently, one of the largest hospitals in Barcelona established a protocol of using Presage ST2 Assay as part of the standard of care for managing patients with heart failure," says James Snider, President of Critical Diagnostics. "Ever more convincing clinical data is coming in on ST2's value in prognosis and care of heart failure patients. In these days of austerity, an assay that can actively improve patient outcomes while reducing overall healthcare costs is in great demand."

Bestbion dx GmbH will distribute the assay in Germany, INyDIA in Spain and Portugal, Eurobio AbCys in France, and Savas Medikal in Turkey.

"We have carefully chosen established, quality distributors," notes Richard Hughes, Vice President, Business Development Europe for Critical Diagnostics. "Each has successfully launched new biomarkers in their respective markets, and believe, like us, that ST2 will be a critical new tool in the evolution of heart failure patient management."