Sepsis remains the leading cause of death in critical care units of Hospitals, affecting to more than 50 million people worldwide yearly, and causes a systemic inflammatory response driven by the production of proinflammatory cytokines. Current available prognostic biomarkers are not useful to assess the gravity of septic patients and predict mortality. SPEDI-TEST represents a unique solution for septic patients by analyzing the early impairment of the activation of the NLRP3 inflammasome, that is associated with more than 80% of the deaths of septic patients. We have developed a novel in vitro prognostic (IVD) product for the fast detection of early impairment of the NLRP3 inflammasome activation, as a biomarker for the prognosis in sepsis. This new IVD method can differentiate patients with increased possibilities of developing late life-threatening complications in sepsis from those who are not in risk to suffer complications, resulting in early and better prognosis to orientate patient treatment/therapies and care. During this project we have validated the IVD test with a new cohort of clinical samples, defining protocols and appropriate reagents. We also performed an analysis and define the regulatory path for the IVD to reach the market, as well as we have created a spin off company to exploit the development of the IVD in base of the business plan performed under this project. This identification of sepsis-related immunosuppression in an advanced phase is key, since it will allow a reduction of the current mortality rates due to sepsis, avoiding further complications, and indirectly reducing healthcare costs.
