The HBP-assay is a novel diagnostic method developed and patented by Hansa Medical to help predict severe sepsis in patients with infectious disease symptoms. Hundreds of thousands of patients die every year due to severe sepsis as a complication to infections like urinary tract infection and pneumonia.
These infections can be effectively treated with antibiotics in order to prevent progression to severe sepsis although early prediction of risk patients is crucial for successful treatment. A seemingly stable infectious disease patient can within hours develop severe sepsis as manifested through clinical symptoms like organ failure and circulatory failure. Early prediction and treatment of risk patients is key to prevent death from severe sepsis.
HBP has been evaluated as a biomarker for prediction of severe sepsis in two clinical studies in Sweden and the US. The studies demonstrate that serum HBP is elevated in more than 80 percent of the patients who develop severe sepsis within 72 hours. HBP, Heparin Binding Protein, also known as Azurocidin, resides in certain immune cells called neutrophils. HBP is a multifunctional inflammatory mediator and can be released from neutrophils in the presence of bacteria.
Commercial development of HBP-assay
Hansa Medical and Axis-Shield Diagnostics Limited signed a collaborative agreement in 2009 for the commercialization of the HBP-assay. Axis-Shield is responsible for all clinical trials and further developments of the assay and Hansa Medical carries certain rights to royalties from Axis-Shield derived from sales of the HBP-assay as well as milestones payments and minimum royalties.
Axis-Shield is developing the HBP testing market globally and is working to attract major global IVD players as potential sublicensees. In order to further strengthen the clinical validity of the HBP-assay, Axis-Shield is currently coordinating additional clinical trials in the US, Europe, China, South Korea and India. In addition, Axis-Shield is also developing alternative versions of the HBP-assay for improved routine clinical applicability.