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BIA-Brukerstyrt innovasjonsarena

Sepsis studies

Alternative title: Sepsis studiene

Awarded: NOK 3.2 mill.

In May 2017, the World Health Organization (WHO) recognized sepsis as a Global Health Priority. Worldwide, sepsis affects up to 31 million people per year; of whom approximately 30% (9 million people) die. Sepsis is the body's life-threatening response to common infections (by bacteria, viruses, fungi and parasites) that can lead to tissue damage, organ failure, and death. Early adequate treatment has been shown to be essential for survival. Thus, identification of sepsis was highlighted as a key challenge in the WHO sepsis resolution, in order to provide adequate treatment that may improve survival in sepsis. However, no biomarker has so far been found useful for accurate sepsis identification. The SME Gentian AS (Moss, Norway) has developed and patented a rapid, cost-effective diagnostic test that detects calprotectin in blood. Calprotectin is present in the cytoplasm of neutrophils and is released into the blood circulation on neutrophil activation due to infection. Because neutrophils are activated early in course of an infection, calprotectin has potential to be an early biomarker for sepsis. Before the start of this project, several studies have found calprotectin to be a promising biomarker for identification of sepsis, but those studies have been small. Thus, there was a need for large-scale clinical studies. In this project, Gentian worked together with national and international medical institutes to assess the clinical use of calprotectin in diagnosis and monitoring of sepsis in both adults and children. The overall goal was to investigate the role of calprotectin in diagnosis and monitoring of severe infections and sepsis and compare its performance with conventional biomarkers. Even though not all the results are analyzed yet, the first indications from studies funded by Forskningsrådet in this project as well as other studies performed by Gentians partners and other publications (unrelated to Gentian), evidence is building up that calprotectin is a valuable biomarker for early detection of infections, estimation of disease severity and prediction of severe form of the disase. Calprotectin seems to perform better as a prognostic and diagnostic marker for severe infections and sepsis compared to conventional markers.

Calprotectin seems to be catching momentum. Academic and clinical knowledge on calprotectin accumulated in the past years and preliminary data from the research (both in this project and other research) is used by Gentian to spread awareness about the biomarker and communicate results to potential customers. This has led directly to the gain of several new routine customers that now include calprotectin in routine analysis of patients presenting with signs of infection, as well as being tested by several hospitals in Scandinavia and rest of Europe. As shown by the research performed, the use of biomarker that performs better than existing routine biomarkers will benefit patients as well as the health care system, enabling early diagnosis and appropriate and rapid treatment and distinguishing between patients expecting to experience mild and severe form of disease.

In May 2017, the World Health Organization (WHO) recognized sepsis as a Global Health Priority. Worldwide, sepsis affects up to 31 million people per year; of whom approximately 30% (9 million people) die. Sepsis is the body’s life-threatening response to common infections (by bacteria, viruses, fungi and parasites) that can lead to tissue damage, organ failure, and death. Early adequate treatment has been shown to be essential for survival. Thus, identification of sepsis was highlighted as a key challenge in the WHO sepsis resolution, in order to provide adequate treatment that may improve survival in sepsis. However, no biomarker has so far been found useful for accurate sepsis identification. The SME Gentian AS (Moss, Norway) has developed and patented a rapid, cost-effective diagnostic test that detects calprotectin in blood. Calprotectin is present in the cytoplasm of neutrophils and is released into the blood circulation on neutrophil activation due to infection. Because neutrophils are activated early in course of an infection, calprotectin has potential to be an early biomarker for sepsis. Indeed, recently performed studies have found calprotectin to be a promising biomarker for identification of sepsis, but those studies have been small. Thus, there is a need for large-scale clinical studies. In this project, Gentian will work together with 3 national and international medical institutes to assess the clinical use of calprotectin in diagnosis and monitoring of sepsis in both adults and children. If calprotectin will be found to have high sensitivity and specificity for sepsis and/or sepsis with a severe course, as hypothesized based on previous studies, it can become a clinically very useful diagnostic test for optimization of sepsis care.

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BIA-Brukerstyrt innovasjonsarena