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HBP-assay website launched

Regulatory information

A dedicated product website for Heparin Binding Protein as biomarker for diagnosis of severe sepsis has been launched by Hansa Medical’s development partner Axis-Shield Diagnostics: www.heparinbindingprotein.com

The goal is to launch a CE-marked HBP-assay in December 2012. Currently, the result from an international pivotal multicentre trial is being evaluated.

Sepsis is the body's systemic inflammatory response to infection and can progress to severe sepsis, septic shock and ultimately multiple organ failure. Early diagnosis and appropriate treatment of severe sepsis is vital to improve the patient's chance of survival. Heparin Binding Protein is a new marker that has been shown to be useful in identifying patients on admission to the Emergency Department who are at risk of developing severe sepsis with circulatory failure.

In 2009, Hansa Medical entered a collaboration and license agreement with Axis-Shield Diagnostics to further develop the Hansa Medical prototype HBP-assay (HMD-301) and subsequently launch a commercial assay. Hansa Medical estimates the market for diagnosis and prognosis of severe sepsis to at least 3 million analyses per year in EU, Japan and the US.