Revolutionising
precision immunology

A functional NLRP3 biomarker platform to transform immunological information into better clinical and therapeutic decisions.

fpunded-eurpe

EIC Transition (abril 2025)

Horizon Europe 2021-2027

Enabling functional immunological stratification

Precision medicine needs to understand what is actually happening in the immune system

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VIVA-ELISA®, a functional NLRP3 biomarker technology

We don’t just measure whether NLRP3 is present. We measure whether the pathway is functionally active

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From validation in sepsis to precision immunology

From validation in sepsis to precision immunology

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Objetive: to translate immunological information into clinical decisions

Same diagnosis, different immune status

Two patients with the same diagnosis may exhibit very different immune responses. Precision medicine requires tools capable of identifying what is actually happening in each patient’s immune system.

Objetive: to translate immunological information into clinical decisions

Functional biomarkers for personalised medicine

Traditional biomarkers do not always capture immune function. VIVA-ELISA® measures the functional activation of the NLRP3 inflammasome using ASC-Specks, providing actionable information on the patient’s immune status.

Objetive: to translate immunological information into clinical decisions

Sepsis: first clinical validation

Sepsis is our first clinical indication due to its immunological complexity and the urgent need for early stratification. Impaired NLRP3 activation is associated with a poorer prognosis, increased clinical risk and immune dysfunction.

Objetive: to translate immunological information into clinical decisions

Beyond sepsis

The technology has the potential to be extended to other inflammatory and immune-mediated diseases. Neuroinflammation, autoimmune diseases, multiple sclerosis, cancer and other inflammatory disorders may benefit from a better functional understanding of the immune system.

Our potential impact

For patients

  • Earlier identification of high-risk immune states.
  • Better stratification for personalised clinical decisions.
  • Potential reduction in complications, mortality and long-term effects in sepsis.

For hospitals and healthcare systems

  • Improved prioritisation of critically ill patients.
  • Support for decision-making in ICUs, A&E departments and personalised medicine pathways.
  • Potential optimisation of resources, length of stay and healthcare costs.

For pharmaceutical and biotech companies

  • Selection of biologically relevant subgroups.
  • Enrichment of clinical trials.
  • Identification of responders.
  • Pharmacodynamic monitoring and therapeutic response.
  • Potential support for biomarker strategies associated with targeted therapies, including possible future developments in personalised medicine.

Clinical validation underway

Bringing functional immunological information from the laboratory into clinical practice.

Our technology is advancing in a multicentre clinical trial for translational validation, with 200 patients already enrolled and a target of 360 patients across leading hospitals and research centres in Spain.

The study involves the analysis of over 100 variables and initially focuses on sepsis, the first clinical indication for validating VIVA-ELISA® as a functional NLRP3 biomarker technology.

Further information about our clinical trial.
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Protected intellectual property

We hold a family of patents protected at European level, including European patent EP 3 938 781 / UP3938781, granted in December 2025, with national validations in Spain, Ireland, Norway, the United Kingdom, Switzerland and Turkey, as well as international applications and extensions currently pending.

Quality, traceability and scalability

We are making progress in implementing the ISO 13485 quality management system and in developing traceability tools tailored to clinical and regulatory development.

European regulatory roadmap

We are working on a regulatory roadmap prioritising CE marking under the IVDR as the primary route to market, with a subsequent assessment of the regulatory strategy for the United States in accordance with the applicable FDA pathway.

Business Acceleration Services, BAS

We are part of the European Innovation Council’s Business Acceleration Services (BAS), a programme designed to accelerate disruptive technologies, build robust business cases and facilitate connections with institutions, corporations, investors and private companies. This support reinforces our evolution from a biomedical technology currently undergoing validation towards a functional immunological information solution with clinical, translational and commercial potential.

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News

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Enabling functional immunological stratification

Precision medicine needs to understand what is actually happening in the immune system. VIVA-ELISA® is a functional NLRP3 biomarker technology based on the detection of ASC-Specks. Its aim is to provide actionable information on the patient’s immune status, helping to identify immune phenotypes, anticipate risks and support more precise clinical and therapeutic decisions.
Our first clinical validation focuses on sepsis, a critical condition in which impaired NLRP3 activation is associated with immune dysfunction, a poorer prognosis and increased clinical risk.
A pioneering innovation serving healthcare professionals, hospitals, research centres, pharmaceutical companies and healthcare systems seeking to advance towards more personalised medicine.

IN SEPSIS, THE COUNTDOWN IS ALWAYS AGAINST THE CLOCK
  • Every hour’s delay in diagnosis increases mortality by 7.6 per cent.
  • 50 per cent of cases are identified too late for effective interventions.
  • Hospital cost: €36,191 average cost per sepsis patient.

International recognition: Viva in Vitro Diagnostics has been selected by the Horizon Europe EIC Transition programme to advance the development and validation of VIVA-ELISA® as a technology with high clinical and translational potential.
VIVA-ELISA®, a functional NLRP3 biomarker technology

An immunological stratification solution for hospitals, research centres and pharmaceutical companies, designed to measure the functional activation of NLRP3 using ASC-Specks and to support more accurate clinical and translational decisions. 

The functional activation of NLRP3 provides insight into innate immune competence, with potential applications in patient stratification, prognosis, therapeutic monitoring and the development of new personalised medicine solutions.

THE CHALLENGE IN PRECISION IMMUNOLOGY
    • Patients with the same diagnosis may present with different immune states.
    • Current biomarkers do not adequately capture immune function.
    • In clinical practice, this lack of information hinders early stratification and risk prediction.
    • In clinical practice, this lack of information hinders early stratification and risk prediction.

The VIVA-ELISA® solution

VIVA-ELISA® is currently undergoing development and clinical validation, with sepsis as its primary indication. It provides a functional assessment of NLRP3 inflammasome activation, with potential applications in patient stratification, prognosis, therapeutic monitoring and biomedical research.

    • Early identification of immune dysfunction: detection of functional abnormalities in the immune system in critically ill patients.
    • Immunological stratification: support for the identification of high-risk patients and distinct immune phenotypes.
    • Personalised medicine: actionable information to guide more precise clinical and therapeutic decisions.
    • Value for pharmaceutical development: potential application in identifying responders, trial enrichment and pharmacodynamic monitoring.
    • Expansion into other medical fields: potential applications in inflammatory, immune-mediated, neurodegenerative and autoimmune diseases, as well as cancer and other disorders linked to precision immunology.

From validation in sepsis to precision immunology

VIVA-ELISA®: an NLRP3 functional technology in clinical and translational development.

VIVA-ELISA® is now moving from laboratory validation towards relevant clinical settings, with the aim of demonstrating the value of functional NLRP3 activation as a biomarker.

Sepsis is the first indication for clinical validation: a critical condition in which early immunological stratification can have clinical and economic implications.

Building on this validation, the scope of the opportunity extends to personalised medicine programmes, NLRP3-targeted therapies, therapeutic programmes related to inflammasomes, and immunomodulation strategies.

Our aim is to translate this validation into the clinical and translational setting, ensuring its applicability in hospitals, research centres and biomedical development programmes.