Viva In Vitro Diagnostics and Vall d’Hebron launch a new research project to enable early diagnosis and stratification of sepsis

Viva In Vitro Diagnostics (www.vivaivd.com), a Spanish company specialized in biotechnological innovation and immunology-based medical solutions, has signed a collaboration agreement with the Vall d'Hebron University Hospital and the Vall d'Hebron Research Institute (VHIR) to carry out a clinical study focused on the functional detection of the NLRP3 inflammasome as a biomarker to improve prognosis¹, immunological stratification, and active monitoring of patients with sepsis.

Each year, more than 13 million people die from sepsis globally, and up to 50% of survivors develop physical or cognitive sequelae, reinfections, or other serious complications-especially those with weakened immune systems (older adults, children, oncology patients, etc.).

This alliance strengthens the strategic roadmap of Viva In Vitro Diagnostics, one of the 40 European companies selected in 2025 by the European Innovation Council (EIC) for its disruptive contribution to precision medicine based on inflammasomes and the development of biotechnological solutions for complex inflammatory diseases (sepsis, cancer, Alzheimer's disease, among others).

Expansion of the clinical study with Vall d'Hebron and VIVA-ELISA® technology

The clinical study will take place entirely at Vall d'Hebron. Specifically, it will assess the activation of the NLRP3 inflammasome and related interleukins as potential biomarkers of diagnosis, severity, and clinical evolution in septic patients. This is a multicenter study, with plans to enroll at least 280 individuals and 80 healthy controls, following a competitive recruitment model. Vall d'Hebron is expected to contribute approximately 75 individuals and 30 healthy controls.

The incorporation of Vall d'Hebron will broaden the patient spectrum, increase analytical capacity, and strengthen the clinical validation of the biomarker based on NLRP3 inflammasome activation using VIVA-ELISA® technology.

This biomarker enables early identification of immune dysfunction in septic patients, enhances prognostic accuracy, and supports personalized therapeutic decisions based on each patient's immune phenotype.

Unlike conventional biomarkers (PCT, CRP, IL-6 or lactate), this approach measures the functional capacity of the innate immune system, providing an essential advantage in the early hours of disease progression.

VIVA-ELISA® quantifies ASC-specks, a direct molecular signal of NLRP3 inflammasome activation, with a high potential to detect patients with poor expected immunological evolution-something current tools cannot reliably predict.

Dr. Ricard Ferrer, Principal Investigator of the study

The study will be led by Dr. Ricard Ferrer Roca, Head of the Intensive Care Medicine Service at Vall d'Hebron University Hospital and leader of the SODIR (Shock, Organ Dysfunction and Resuscitation) research group at VHIR.

Dr. Ferrer is an internationally recognized expert in sepsis, severe infections, and intensive care medicine. He is Associate Professor at the University of Barcelona, Codirector of the Severe Infections and Sepsis Masterclass at ESICM, former President of SEMICYUC, Treasurer of the European Society of Intensive Care Medicine (ESICM), member of the World Federation of Intensive and Critical Care (WFICC), and Trustee of the Código Sepsis Foundation.

His leadership in international research networks and extensive clinical experience provide the study with an exceptional scientific and strategic foundation. Dr. Ferrer will also serve as an external advisor to the Medical Advisory Board of Viva In Vitro Diagnostics.

Strengthening existing alliances with public health systems in Andalucía and Murcia

The participation of Vall d'Hebron University Hospital and VHIR reinforces the multicenter project that Viva In Vitro Diagnostics is already developing with the Murcian Health Service and the Andalusian Health Service, through: Virgen de la Arrixaca Hospital (Murcia); Virgen de la Victoria Hospital (Málaga); Jerez de la Frontera Hospital (Cádiz); with the involvement of FFIS, FIMABIS, FCADIZ, and research institutions such as IMIB, IBIMA, and INIBICA.

Dr. Verónica Cánovas Hernández, Biotechnological Development Manager at Viva In Vitro Diagnostics, is the Principal Investigator and coordinator of the overall project.

Vall d'Hebron: a European benchmark in clinical and translational research

The Vall d'Hebron University Hospital, managed by the Institut Català de la Salut (ICS), is one of the largest hospital complexes in Spain and an international reference in critical care. Its Intensive Care Medicine Service is an ideal environment to evaluate high-impact clinical biomarkers such as NLRP3.

The Vall d'Hebron Research Institute (VHIR) is a public institution that has driven biomedical research, innovation, and teaching at Vall d'Hebron since 1994, becoming one of Europe's leading centers for clinical and translational research.

Sepsis: a global health crisis requiring new diagnostic tools

Sepsis remains one of the leading causes of in-hospital mortality:

• Up to 75% of ICU patients may develop sepsis.
• Between 20% and 50% progress to septic shock.
• Between 30% and 60% die as a result.
• Nearly 50% of survivors suffer long-term physical or cognitive sequelae.

Early immunological stratification represents a major shift in clinical practice and decision-making in critical care.

Toni Vilaplana, General Director of Viva In Vitro Diagnostics: "The incorporation of VHIR and Dr. Ferrer strengthens the ambition of the project, which is key to Europe's scientific and medical autonomy in a context of global competitiveness. It also allows us to advance toward more precise, faster and clinically useful immunological diagnostic tools."

Dr. Ricard Ferrer, Principal Investigator at Vall d'Hebron: "For me, collaborating with Viva In Vitro Diagnostics is a unique opportunity to advance the diagnosis and treatment of sepsis, one of the greatest challenges in critical care. Leading this project from Vall d'Hebron and clinically validating new tools such as the NLRP3 biomarker, using VIVA-ELISA® technology, represents a significant step forward toward a more personalized and precise medicine. This alliance will help us offer faster and more effective responses to the most severe patients. I am convinced that the combination of clinical expertise, research and disruptive technology brought by Viva In Vitro Diagnostics will make a difference in patient outcomes and help transform clinical practice in sepsis."