Sepsis

Novel blood test(s) to improve diagnosis and early intervention in sepsis

Sepsis (blood poisoning) is a life-threatening syndrome characterized by a systemic host response to infection, which can cause organ failure and death in severe cases.

Sepsis accounts for over 10% of intensive care unit (ICU) admissions and is the leading cause of death in the non-coronary intensive care unit. Each year over 750,000 new cases are detected in the US alone, with a mortality rate reaching nearly 30%, thereby ranking it in the top ten causes of death. The total annual treatment costs in the USA amount to more than $16 billion and are still rising. Early goal-directed therapy can significantly reduce sepsis mortality validating the benefit of early identification of the syndrome and aggressive management.

Early diagnosis and appropriate therapy of sepsis is a daily challenge in intensive care units. In order to enable a meaningful impact on individual patient outcome, reliable biomarkers for the early and accurate detection of sepsis are badly needed. Equally important are novel biomarkers for risk stratification of patients who will develop severe sepsis, in order to facilitate early intervention.

Pronota has applied its proprietary biomarker discovery pipeline to identify new biomarker candidates for the early and definitive diagnosis of sepsis from infection-free severe systemic inflammation (SIRS). A similar strategy was followed to identify new protein biomarkers for prognosis. A large set of potential new biomarker hits has been identified in this way. One of these hits, for which Pronota has filed patents, can be linked to a recently discovered novel antimicrobial action mechanism, called neutrophil extracellular traps (NETs). Furthermore the function of this family of molecules can be linked to the mechanism of action of the only FDA approved treatment for sepsis, opening avenues for use as companion diagnostic.

The selected biomarker hits are now subject to early clinical validation screening in large set of human samples to test their performance as sepsis biomarkers using proprietary MASSterclass™ technology.