EpiDisease, in collaboration with CIBER and INCLIVA, proudly announces the successful kick-off meeting of the HistSHOCK clinical performance trial, held on July 11-12, 2024 at the INCLIVA building in Valencia. This pivotal event marks the beginning of a transformative project aimed at improving the diagnosis, management and prognosis of sepsis
HistSHOCK, an innovative In Vitro Diagnostic (IVD) tool currently being developed by EpiDisease, a company located at the University of Valencia Science Park, and developed from a CIBER, University of Valencia and INCLIVA patent, is set to revolutionize sepsis care. The tool is designed to improve early diagnosis and treatment strategies, significantly improving patient outcomes and reducing sepsis-related mortality.
The inaugural meeting brought together leading experts in critical care and sepsis treatment, who will serve as principal investigators at their respective centers throughout the HistSHOCK trial. Their participation is essential to the successful implementation and validation of the DIV HistSHOCK trial.
The HistSHOCK project received nearly two million euros in funding in May 2023 to advance its development. This significant financial support was provided by the Center for Technological Development and Innovation (CDTI) and the European Union through the Horizon Europe Seal of Excellence SME grant program and the EU's Next Generation funds. This investment highlights the critical importance and potential impact of the HistSHOCK project in addressing the global challenge of sepsis.
The HistSHOCK clinical performance trial is a multi-center, international study involving hospitals in Spain and Italy. The trial will rigorously evaluate the efficacy and reliability of the HistSHOCK IVD tool in the intensive care clinical setting. In addition, the project includes the preparation of the technical dossier for submission to the EU regulatory authorities, with a view to its approval as an in vitro diagnostic product with CE-IVD marking and subsequent commercial launch.
"If we have come this far it is largely because we are fascinated by the subject, by mutual respect and teamwork, and above all by the importance of its future application to improve the prognosis of the critically ill patient with sepsis as a heterogeneous entity that requires precision medicine", Edurne Carbonell, Intensivist at the University Clinical Hospital of Valencia
José Luis Garciá-Giménez, co-founder of EpiDisease, was enthusiastic about the project: “The HistSHOCK clinical trial represents an important step forward in our mission to combat sepsis. We are delighted to collaborate with esteemed leaders in the field and are confident that the HistSHOCK IVD trial will set a new standard for the diagnosis and management of sepsis.”
Ricard Ferrer, Head of Intensive Care at Hospital Val de Hebrón (Barcelona) and Principal Investigator in the HistSHOCK clinical performance trial, added “it is exciting to see how the research results of a tremendously enthusiastic group are beginning to translate into the care process. It is anticipated that HistSHOCK will be a useful tool when it becomes available to improve clinical outcomes in sepsis.” Sepsis, a disease with a high incidence and high mortality, needs more groups like EpiDisease doing research to improve the prognosis of patients with this severe form of infection.”
Another of the Principal Investigators of the HistSHOCK study, Antonio Artigas, Emeritus researcher at the Parc Taulí University Hospital in Sabadell and professor and director of the Chair of Applied Physiology at the Parc Taulí University Institute, commented “It has been a very interesting and fruitful meeting where several ideas for the realization of the research project, as well as its potential future application in clinical practice, have been pointed out. Ideas were also provided for the analysis of histones in different samples such as urine, bronchoalveolar lavage and also in plasma samples stored with heparin. The determination of biomarkers [such as those detected by HistSHOCK] for detection, early diagnosis and prognostic value in patients with sepsis is a necessity and is recommended by WHO and the Global Sepsis Alliance to improve the survival of patients with sepsis.”
Edurne Carbonell, Intensivist at the University Clinical Hospital of Valencia and specialist in the management of sepsis, who has collaborated in the HistSHOCK project since its inception as a pure clinical R&D research reflected “If we have come this far it is largely because we are fascinated by the subject, by mutual respect and teamwork, and above all by the importance of its future application to improve the prognosis of the critically ill patient with sepsis as a heterogeneous entity that requires precision medicine. It seems that omics can help in the future, and the role of histones as biomarkers in the diagnosis and prognosis of sepsis is emerging. The collaboration in this project with other centers that provides scientific evidence to make its transcendence and positioning in clinical practice a reality is one of the major advances on this path”.
A medida que avance el proyecto HistSHOCK, se compartirán actualizaciones y hallazgos con la comunidad médica y el público, mostrando los avances logrados en la lucha contra la sepsis.
About EpiDisease
EpiDisease is a biotechnology company specialized in the development of diagnostic tools and therapies for complex diseases. Located at the University of Valencia Science Park, EpiDisease collaborates with leading research institutions to drive innovation in medical sciences.
About CIBER
The Center for Biomedical Research Network (CIBER) is a public consortium created to promote research excellence in biomedicine and health sciences. The CIBER works in various areas of health research, promoting collaboration and innovation.
About INCLIVA
INCLIVA is a leading research institute affiliated with the University of Valencia, dedicated to advancing biomedical research and translating discoveries into clinical practice. INCLIVA supports a wide range of research projects aimed at improving patient outcomes and healthcare delivery.