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Axis-Shield and Bio-Rad Sign Agreement for Commercialization of Sepsis Biomarker

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Scottish diagnostics firm Axis-Shield announced this week an agreement to allow Bio-Rad Laboratories an option to commercialize heparin binding protein as a biomarker for severe sepsis.

Under the terms of the agreement, the financial details of which were not disclosed, Bio-Rad will have the right to develop the HBP marker for use on its proprietary laboratory instruments worldwide.

The deal follows on a 2007 agreement between the two companies for the commercialization of a test for the early detection of rheumatoid arthritis based on Axis-Shield's proprietary anti-CCP technology. Marketed by Bio-Rad as the BioPlex 2200 Anti-CCP test, this diagnostic received US Food and Drug Administration approval in October (GWDN 10/13/2010).

Sepsis kills an estimated 200,000 people in the US each year. For every hour that severe sepsis is identified and treated, survival rates increase by 7.5 percent – highlighting the need for effective early-detection methods. In preliminary clinical studies, HBP has shown improved specificity and sensitivity for severe sepsis compared to existing methods of detection, Axis-Shield said in a statement.

The companies are not alone in developing early detection biomarkers for the disease. Thermo Fisher Scientific this week announced it will be showcasing its BRAHMS clinical assay for procalcitonin – another sepsis biomarker – at the Society of Critical Care Medicine's 40th Critical Care Conference in San Diego next week. The PCT assay received 510(k) clearance by the FDA in April 2008 and has been used in Europe for sepsis risk assessment for more than a decade.

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