EpiDisease, a spin-off of the Consortium for Networked Biomedical Research and INCLIVA located at the University of Valencia Science Park, has received nearly two million euros to continue the development of its IVD test HISTSHOCK, dedicated to the diagnosis and prognosis of sepsis and septic shock. The funding is part of the support from the Center for Technological Development and Innovation (CDTI) and the European Union through the Horizon Europe Seal of Excellence SME grant program and the Next Generation EU funds. The funds will be used for the execution of a multicenter, international clinical trial involving hospitals in Spain, Italy, Denmark and the Netherlands, as well as the preparation of the technical dossier for the EU regulatory authorities for approval as an in vitro diagnostic product with CE-IVD marking and its commercial launch.
The Parc Científic biomedical company demonstrated HISTSHOCK's capabilities in a proof-of-concept study published in 2017, in which circulating histone levels in blood obtained high sensitivity and specificity for the diagnosis of sepsis and septic shock versus healthy controls. Subsequent analyses, performed in 2019, demonstrated the ability of histone H2B to diagnose this pathological condition within the Intensive Care Unit (ICU) setting.
"The financial support recognizes the need for the development of new IVD tests, assuming the profound negative impact caused by the lack of robust tools and the significant associated socioeconomic burden, and also the disruptive change that HISTSHOCK will provide in clinical decision-making and management of this pathology," celebrates José Luis García Giménez, CEO of EpiDisease.
In 2021, the company developed a prototype kit that maintained the analytical properties, and guaranteed the scalability of the technology. That same year, EpiDisease achieved scientific validation of this prototype according to recommendations received from an expert consultancy in the development of medical diagnostic tools. The development of the kit prototype has been carried out through a valorization project with funding from the Agència Valenciana de la Innovació. Regarding the scientific validation and analytical validity, the project has been funded through the Foundation for Innovation and Prospective Health in Spain (FIPSE). All for the benefit of the development and commercialization of the tool.
"The financial support recognizes the need for the development of new IVD tests, assuming the profound negative impact caused by the lack of robust tools and the significant socioeconomic burden associated with the diagnosis and follow-up of sepsis, and also the disruptive change that HISTSHOCK will provide in the clinical decision-making and management of this pathology," José Luis García Giménez, CEO of EpiDisease.
A study conducted in 2021 with a total of 140 patients demonstrated the ability of HISTSHOCK for the diagnosis and prognosis of sepsis and septic shock in the ICU setting. "In this study, diagnostic sensitivity was 77% and specificity was 89%. The prognostic results showed a sensitivity of 83% and specificity ranging from 63%-74. The test demonstrated its ability to identify disseminated intravascular coagulation (DIC) early with a sensitivity of 70% and specificity of 71%," explains García Giménez, CEO of the company.
A revolutionary change to treat sepsis
HISTSHOCK is the first molecular test to demonstrate a prognostic capability that could be applied in clinical situations to aid in preventive decision making for the management of sepsis, allowing evidence-based personalized and sepsis-modifying treatments to be employed. This feature could revolutionize the treatment of patients with sepsis by providing information on the likely progression of the disease in each patient, and would provide clinicians with a tool that enables anticipatory patient management.
"HISTSHOCK represents a disruptive element in the therapeutic area of sepsis," stresses James Webb, commercial director of the biomedical company. "Specialists in emergency departments and intensive care units have never had access to a robust, reproducible tool with diagnostic and prognostic capabilities to support their critical and life-saving decision making," describes Webb.
"It will change the way sepsis is treated worldwide. It will hopefully result in reduced mortality rates, better long-term outcomes for patients and more efficient use of limited healthcare resources," James Webb, chief commercial officer of biomedical company
The possibility of having a test that can classify patients at first contact and predict with a high degree of confidence the severity of the current septic process facilitates the application of the most appropriate life-sustaining therapy for each patient. "It will change the way sepsis is treated worldwide. It will hopefully result in reduced mortality rates, better long-term outcomes for patients and more efficient use of limited healthcare resources," Webb stresses.
The Parc company
EpiDisease S.L. was born in 2014 as a spin off of INCLIVA, the CIBER of the Carlos III Health Institute and the University of Valencia, with the intention of transferring knowledge in the field of epigenetics and biomedical sciences to the service of society. Along with the development of HISTSHOCK, EpiDisease S.L. is currently developing a portfolio of clinical tools for the diagnosis, prognosis and management of adolescent idiopathic scoliosis that help healthcare professionals to make evidence-based decisions based on individual genetic and epigenetic biomarkers, The CDTI-E.P.E. is a Public Business Entity, under the Ministry of Science and Innovation, which promotes innovation and technological development of Spanish companies. It is the entity that channels applications for aid and support for R&D&I projects of Spanish companies at the national and international level.
*Project funded by the European Union - NextGenerationEU. However, the views and opinions expressed are solely those of the author(s) and do not necessarily reflect those of the European Union or the European Commission. Neither the European Union nor the European Commission can be held responsible for them.