The INCLIVA Health Research Institute, at the University Clinical Hospital of Valencia, has signed a collaboration agreement with Viva In Vitro Diagnostics, a Spanish company specializing in the research and development of solutions and services in the fields of biotechnology and immunology, to promote the clinical validation of its technology aimed at improving the diagnosis and management of patients with sepsis.

The study is part of a multicenter project already underway in three other autonomous communities, which aims to evaluate new biomarkers—biological indicators that allow for the measurement of bodily processes—related to the immune system's response. It will be led in Valencia by Dr. Gerardo Aguilar, from the Anesthesiology and Resuscitation Research Group at INCLIVA, head of the Critical Care Unit of the Anesthesiology Department at the University Clinical Hospital of Valencia, and professor of Anesthesiology and Intensive Care at the Faculty of Medicine of the University of Valencia. He is also a researcher at the Biomedical Research Networking Center for Infectious Diseases (CIBERINFEC) of the Carlos III Health Institute.

Specifically, the research focuses on the functional activation of the NLRP3 inflammasome and other associated interleukins, key mechanisms of the innate immune system that regulate the body's inflammatory response and whose alteration can influence the clinical course of patients. Its analysis can provide relevant information on early diagnosis, potential severity, clinical evolution, and prognosis.

Dr. Aguilar's expertise will allow for the inclusion of sepsis patients treated in both emergency departments and intensive care units, in order to evaluate the clinical value of these biomarkers in a real-world healthcare setting. In this regard, Dr. Aguilar thanked Viva In Vitro Diagnostics for the trust placed in him, the University Clinical Hospital of Valencia, and INCLIVA to lead this line of research, and expressed his conviction that “this collaboration will significantly contribute to generating solid clinical evidence and bringing precision medicine closer to daily clinical practice.”

For his part, the CEO of Viva in Vitro Diagnostics, Antonio Vilaplana, highlighted that the agreement “represents a very important step in the clinical validation of diagnostic solutions based on the activation of the NLRP3 inflammasome and in the development of tools that facilitate earlier immunological stratification and better therapeutic decision-making in sepsis.”

Moving towards robust multicenter clinical validation

The incorporation of the University Clinical Hospital of Valencia reinforces the multicenter nature of the study and allows for progress in translational immunology within the real hospital setting. The expansion to the Valencian healthcare system increases the diversity of patients included and strengthens the clinical evidence necessary for the future application of this technology.

In this context, the VIVA-ELISA® technology, based on the quantification of molecular signals associated with the activation of the NLRP3 inflammasome, aims to provide functional information on the state of the patient's innate immune system. This approach represents an advance over conventional biomarkers, facilitating an earlier and more accurate assessment of the risk of adverse clinical outcomes in critically ill patients.

The development of tools capable of anticipating immune dysfunction can contribute to improving therapeutic decision-making, personalizing treatment, and reducing mortality associated with sepsis, one of the leading causes of hospital death worldwide.

Consolidation of a National Clinical Network for Sepsis

With this agreement, Viva In Vitro Diagnostics expands its collaborative network with leading hospitals and public health systems in Spain. The project has active agreements with centers such as Vall d’Hebron University Hospital (Barcelona), Virgen de la Arrixaca University Hospital (Murcia), Virgen de la Victoria University Hospital (Málaga), and Jerez de la Frontera University Hospital (Cádiz).

These collaborations are being developed in coordination with scientific institutions such as IMIB (Murcian Institute for Biomedical Research), VHIR (Vall d'Hebron Research Institute), IBIMA (Biomedical Research Institute of Malaga), and INIBICA (Biomedical Research and Innovation Institute of Cadiz), to which INCLIVA has now been added, as well as with the regional health services of Catalonia, Andalusia, and Murcia. This creates a clinical-research ecosystem aimed at accelerating the arrival of precision medicine solutions for the management of sepsis. Among its founders are Dr. Pablo Pelegrín, scientific advisor to the Steering Committee, Deputy Scientific Director of IMIB, and Professor of Immunology at the University of Murcia; and Dr. Carlos García-Palenciano, clinical advisor and Head of the Anesthesia and Resuscitation Department at the Virgen de la Arrixaca University Hospital (Murcia).

Innovation in Immunological Diagnostics

Viva In Vitro Diagnostics, created as a spin-off of the Murcian Institute for Biomedical Research (IMIB) in 2021, develops diagnostic solutions focused on the activation of the NLRP3 inflammasome as a cornerstone of personalized medicine for complex inflammatory diseases, primarily sepsis, multiple sclerosis, Alzheimer's, and cancer, among others.

The company is among those selected by the European EIC Transition program for its disruptive potential in biotechnology and has received a grant of nearly €2.5 million from the European Commission to boost the clinical application of its developments.