One year ago, Viva In Vitro Diagnostics entered a new stage after being selected for the European Innovation Council’s EIC Transition programme, one of Europe’s most relevant initiatives for supporting disruptive technologies with the potential to reach the market and generate real impact for society.
The €2.5 million in funding received through this programme represented far more than recognition. It gave us a working framework, a demanding roadmap and a clear responsibility: to move from scientific strength to execution, clinical validation, regulatory development, industrial readiness and market access.
One year later, this process has reinforced our vision. In biomedicine, and particularly in in vitro diagnostics, developing an innovative technology is not enough. The real challenge is to demonstrate that the technology can be integrated into clinical practice, provide useful information to healthcare professionals, improve decision-making and contribute to a more efficient use of healthcare system resources.
This is Viva In Vitro Diagnostics’ value proposition: to develop precision immunology solutions capable of providing actionable information about a patient’s immune status, starting with sepsis and with the potential to be applied to other complex inflammatory diseases.
From the Laboratory to the Healthcare System: A New Requirement for Innovation
For years, much of the discussion in the in vitro diagnostics sector has focused on three major milestones: analytical validation, clinical validation and regulatory approval.
These elements remain essential. Without scientific evidence, quality and regulatory compliance, there can be no viable healthcare innovation. However, the European and Spanish context is rapidly evolving towards a broader question:
What value does a technology deliver compared with existing alternatives?
The recent approval of Royal Decree 415/2026, of 27 May, regulating health technology assessment in Spain, marks an important change in this regard. The regulation establishes a national framework for assessing medicines, medical devices, diagnostic tests, digital therapies, clinical procedures and other technologies used within the Spanish National Health System.
Its approach connects directly with a trend that is already transforming the healthcare sector across Europe: innovation will no longer be assessed solely on its technical or scientific capabilities, but also on its clinical, economic, organisational, social, ethical and environmental contribution.
For companies such as Viva In Vitro Diagnostics, this change confirms a strategic direction that we have been building from the outset.
What This New Framework Means for In Vitro Diagnostics
In vitro diagnostics is at a decisive moment. Diagnostic technologies do not usually act directly on the patient in the same way as a medicine or therapeutic intervention. In many cases, their impact is indirect.
A biomarker does not cure a patient on its own.
A diagnostic test does not administer a treatment.
But it can change the quality of the clinical decision that follows.
A large part of its value lies precisely there. A diagnostic test can help stratify patients more effectively, reduce clinical uncertainty, guide the use of hospital resources, support more precise therapeutic decisions and improve care pathways.
In this new environment, it will no longer be enough to demonstrate that a test is sensitive, specific or technically robust. It will also be necessary to explain clearly how it supports the healthcare system:
This evolution is especially important in complex diseases with rapid progression and a major clinical impact, such as sepsis.
VIVA-ELISA: A Technology Designed to Provide Clinically Useful Information
VIVA-ELISA® is the technology we are developing at Viva In Vitro Diagnostics to detect the functional activation of the NLRP3 inflammasome through ASC-Specks in critically ill septic patients.
Our objective is not simply to develop an innovative test. Our objective is to provide relevant information about the patient’s immune status in order to contribute to better prognosis, stratification and clinical monitoring.
Sepsis remains one of the major challenges facing healthcare systems. Its progression can be rapid, heterogeneous and difficult to anticipate. In many cases, healthcare professionals need more precise information to identify which patients may deteriorate, which immune profiles require closer monitoring and how clinical decisions should be adapted to each situation.
From this perspective, VIVA-ELISA® aims to provide a new layer of information based on NLRP3 inflammasome activation. This information may be especially relevant for advancing towards more personalised medicine in critically ill patients.
Viva In Vitro Diagnostics’ value proposition is built precisely around this vision: transforming advanced scientific knowledge into diagnostic tools that are useful for physicians, hospitals, healthcare systems, pharmaceutical companies, research centres and laboratories.
Multicentre Clinical Validation: Advancing in Real-World Care Settings
One of the most important developments over the past year has been the consolidation of a national clinical network to validate our technology in real-world care settings.
In April 2026, the INCLIVA Health Research Institute, linked to the Hospital Clínico Universitario de València, became the latest centre to sign a collaboration agreement with Viva In Vitro Diagnostics to support the clinical validation of our technology aimed at improving diagnosis, prognosis and the management of patients with sepsis. And there will be more new announcements soon.
INCLIVA and the Hospital Clínico Universitario de València have therefore joined a multicentre project already under way in several autonomous regions, which seeks to assess new biomarkers linked to the immune system response.
Their experience will support the inclusion of patients with sepsis treated both in emergency departments and intensive care units, with the aim of assessing the clinical value of these biomarkers in a real-world care setting.
This point is particularly important. If we want to demonstrate value, we need evidence generated under real clinical conditions, with real patients, real professionals and real hospital workflows.
The incorporation of the Hospital Clínico Universitario de València strengthens the multicentre nature of the study, increases the diversity of the patients included and reinforces the clinical evidence needed for the future application of this technology.
A National Clinical Network Focused on Precision Medicine in Sepsis
Through this agreement, Viva In Vitro Diagnostics is expanding its collaboration network with leading hospitals and public healthcare systems in Spain.
The project includes active agreements with centres such as Hospital Universitario Vall d’Hebron in Barcelona; Hospital Universitario Virgen de la Arrixaca in Murcia; Hospital Universitario Virgen de la Victoria in Málaga; Hospital Universitario de Jerez de la Frontera in Cádiz; and now Hospital Clínico Universitario de València.
These collaborations are being developed in coordination with scientific institutions such as IMIB, the Murcia Biomedical Research Institute; VHIR, the Vall d’Hebron Research Institute; IBIMA, the Biomedical Research Institute of Málaga; INIBICA, the Biomedical Research and Innovation Institute of Cádiz; and INCLIVA, the Health Research Institute of the Hospital Clínico Universitario de València.
This network forms a clinical and research ecosystem focused on accelerating the arrival of precision medicine solutions for the management of sepsis.
It also reflects a central idea for Viva In Vitro Diagnostics: biomedical innovation cannot be developed in isolation from hospitals. It must be built together with clinical teams, researchers, public healthcare systems and institutions that understand the real needs of critically ill patients.
One Year of Progress Within the EIC Transition Programme
The first year within the EIC Transition programme has represented a highly demanding stage for the entire Viva In Vitro Diagnostics team. Returning to the analysis of the Royal Decree, we are ready for the future — and the present — that is being demanded of us as a biotechnology company.
We have made progress in the development of VIVA-ELISA®, in consolidating our regulatory and quality roadmap, in preparing clinical validation, in protecting our assets, in defining the market and in building a value narrative aligned with new European requirements.
We have also reinforced one key idea: market access begins long before regulatory approval.
Today, a clinical development strategy must be designed from the outset by integrating scientific evidence, regulatory requirements, clinical utility, value for the healthcare system and future adoption by healthcare professionals.
This means considering from the earliest stages aspects such as:
The new Spanish health technology assessment framework reinforces this vision. For an in vitro diagnostics company, reaching the regulatory finish line is no longer enough. The real goal is to demonstrate value.
Thanks to the European Innovation Council and Our Partners
This first year of EIC Transition has also been an opportunity to learn, adapt and grow with the support of a first-class ecosystem.
We would like to thank the European Commission, the European Innovation Council and the entire EIC Transition programme team for their guidance, advice and support throughout this process. Their role has been essential not only as funders, but also as drivers of a culture of excellence, execution and European ambition for biomedical companies with an international outlook.
We would also like to recognise the work of our clinical, scientific, institutional and strategic partners, who are playing a fundamental role in helping us move forward at this stage.
And, of course, our thanks go to our scientific, technical, clinical, regulatory, quality, business development, management and communications teams. Biomedical innovation does not move forward simply because of a good idea. It moves forward when teams are capable of turning that idea into evidence, a product, a process, value and trust.
A New Stage for European Biomedical Innovation
Therefore, the Royal Decree on Health Technology Assessment and the European HTA framework remind us of something essential: healthcare systems need innovation, but they need innovation that demonstrates value.
This should not be interpreted as a barrier, but as an opportunity.
For companies that work with rigour, clinical vision and a focus on impact, this new context may help distinguish more clearly those technologies that genuinely deliver an improvement over the current standard.
At Viva In Vitro Diagnostics, we believe that the future of in vitro diagnostics will be shaped by technologies capable of combining science, clinical utility, hospital integration, evidence of value and sustainability.
Our ambition is to contribute to that future from the field of precision immunology, starting with sepsis and moving towards other complex inflammatory diseases in which the NLRP3 inflammasome may play a relevant role.
One year after beginning our journey within the EIC Transition programme, we remain convinced that innovation only achieves its true purpose when it reaches clinical practice and helps improve decision-making.
Because in healthcare, reaching the finish line is no longer enough.
The challenge now is to demonstrate that reaching that finish line improves the journey for patients, professionals and healthcare systems.
By: Viva in Vitro Diagnostics
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