Critical Diagnostics Accelerates European Rollout of Presage® ST2 Assay

Critical Diagnostics Accelerates European Rollout of Presage® ST2 Assay

<0> Critical DiagnosticsDennis Dalangin, VP MarketingTelephone: 877-700-1250Email: </0>

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.

"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 health care costs is in great demand."

Critical Diagnostics has chosen Bestbion dx GmbH as its exclusive distributor in Germany. Headquartered in Cologne, Bestbion has a highly skilled team, one that helped to launch BNP in Germany. Their existing network of contacts and knowledge of cardiac biomarkers is second to none.

In Spain and Portugal, Critical Diagnostics have partnered with Madrid-based INyDIA. INyDIA have been instrumental in helping Critical Diagnostics to gain a foothold in the competitive Spanish market with the Company’s first clinical placement at the Hospital Germans Trias i Pujol in Barcelona.

In France the Company’s new partner will be Eurobio AbCys. Based in Paris, this 50-year old company headed up by Jean-Michel Carle and his team of seasoned professionals, have extensive experience of launching new biomarkers in France, including BNP and NGAL.

Completing this phase of growth is Savas Medikal, based in Istanbul, Turkey. Savas Medikal have been serving the Turkish medical diagnostics market for nearly 20 years. They are also the exclusive distributors of several well-known cardiovascular diagnostic products.

“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.”

ST2 has now been published in more than 50 peer-reviewed articles studying more than 31,000 patients. These clinical studies have demonstrated that high levels of soluble ST2 are predictive of adverse patient outcomes and death in a broad spectrum of cardiovascular disease. They have further shown that the prognostic information from soluble ST2 is independent and provides added information to cardiac biomarkers commonly used today, including the natriuretic peptides, BNP and NT-proBNP.

Critical Diagnostics () develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs. 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.