Sepsis is a life-threatening condition that arises when the body's response to an infection damages its own tissues and organs. Although sepsis is initiated by infection, it is not the infection per se, which kills a patient, but rather the body’s response to it, in particular, development of a shock, which is initiated by deterioration of blood vessel system, hypotension, insufficient perfusion and organ oxygenation and finally organ failure. For a clinician this situation occurs suddenly and there is no diagnostic tool to predict this event early enough to initiate adequate measures to guide the patient and prevent its death.
Despite of large efforts and developments in the last decade septic shock is still one of the world biggest killer causing 5-6 million deaths a year worldwide. Thus the septic shock prediction and stratification of high risk patients is still an unmet medical need.
Bio-ADM is a novel marker in sepsis to reliably identify patients with a high risk of developing septic shock, who are having a high mortality and a need for vasopressor treatment.
During the project scientists of Sphingotec (SPH) developed bio-ADM as a powerful marker to predict fatal shock progression in severe sepsis.
Accordingly, main goal of the project was to validate the clinical utility of bio-ADM as biomarker in European intensive and emergency care for identification of critically ill patients with the highest risk of developing shock, in order to enable earlier treatment options. This will change the standard of care in sepsis patient management. Furthermore, all necessary dissemination was made to guarantee quick market uptake and broad clinical marker application.
Within project, Sphingotec fulfilled all objectives:
1. Prototyping for clinical application
Sphingotec estabilished a highly reliable in-vitro diagnostic (IVD) bio-ADM assay for routine clinical application.
2. Clinical validation
Sphingotec conducted a large observational clinical study with 585 sepsis patients on the Intensive Care Units (ICU). In the study: (i) we confirmed significant data from the pilot study of Marino et al 2014 Crit Care, (ii) we confirmed the cut-off-value for bio-ADM measurement in clinical routine to identify patients with highest risk to die and to indicate vasopressor therapy at the earliest stage and thus help to save lives, (iii) we showed high performance of the marker in comparison to established clinical chemistry parameters (according to international sepsis guidelines), (iv) we delivered clinical data for a broad clinical exploitation of the biomarker.
3. Establishing automation of assay to enhance European and worldwide exploitation
bio-ADM analysis was adapted for automation as random access format of the assay and for point-of-care platform (POC) together with designated industrial licensing parties.
4. Scale-up of production capacity and preparation of the company for growth
New staff for the project (for research, development, clinical profiling, production and marketing) has been employed. Structure for continuous growth of company after the project were implemented.
5. Market replication
For dissemination of bio-ADM as clinical marker, several retrospective studies for the application of bio-ADM in analogous clinical questions had to be conducted, e. g. bio-ADM in German and international cohorts for sepsis, septic shock and in acute heart failure.
6. Prepare product launch
Launch of bio-ADM as clinical marker in 2017 was prepared and conducted.
7. Fulfilling regulatory requirements
During the project all work for the bio-ADM assay was in compliance with the European Directive on In Vitro Diagnostic Medical Devices (98/79/EC) as well as all regulatory ethic and data safety requirements were fulfilled.
