Biotechnology is driving earlier and more personalised approaches to sepsis

Sepsis remains one of the major global public health challenges. It is a medical emergency caused by an extreme response by the body to an infection, which can lead to organ dysfunction, multiple organ failure and death if it is not identified and treated promptly.

The global estimates referenced by the World Health Organization put its impact at 48.9 million cases and 11 million sepsis-related deaths, accounting for approximately 20% of all deaths worldwide. In Spain, around 50,000 people are affected each year and approximately 17,000 die, according to data released in 2026 by Hospital Universitario de La Princesa. Its high mortality rate and the speed at which it can progress make time a critical factor in its management.

Despite advances, sepsis continues to pose significant challenges related to early detection, the heterogeneity of patients’ immune responses, the identification and stratification of those at greatest risk of deterioration, and antimicrobial resistance. These clinical challenges are compounded by its impact on intensive care units and healthcare resources.

Against this backdrop, biotechnology is opening up new possibilities for moving towards an earlier and more personalised approach. Viva In Vitro Diagnostics, an AseBio member, is working on the development and clinical validation of new biomarkers related to the immune response, with the aim of improving prognosis, immune stratification and patient monitoring in sepsis. Its VIVA-ELISA® technology measures functional NLRP3 inflammasome activation and is currently being evaluated in collaboration with different Spanish hospitals and research centres.

On the occasion of World Sepsis Day, AseBio examines the main challenges posed by this medical emergency from four complementary perspectives: clinical practice and the future of sepsis management, its impact on ICUs and the healthcare system, and the research and validation of new tools to advance towards precision medicine.

Detect Earlier and Treat More Precisely

One of the main challenges in managing sepsis remains its early detection across very different clinical settings. The disease can be identified both in people arriving at emergency departments with an acute infection and in patients who are already hospitalised and present with multiple underlying conditions, complex treatments and less specific clinical signs.

For Dr. Ricard Ferrer, Head of the Shock, Organ Dysfunction and Resuscitation Research Group at the Vall Hebron Institut de Recerca and Head of the Intensive Care Department at Vall d’Hebron Hospital Universitari, one of the key challenges is identifying which patients are developing a dysregulated response to infection before irreversible organ damage occurs. This requires diagnostic tools that remain reliable across very different clinical scenarios and patient profiles.

In this regard, Ferrer sees the greatest room for improvement in combining clinical assessment with more accurate biomarkers and clinical decision-support tools that can enable sepsis to be recognised early and consistently across different healthcare settings. In this process, he points out that “digitalisation and artificial intelligence tools, integrated into the care process, will probably be instrumental in driving this change”. Earlier detection would allow appropriate treatments to be initiated sooner, helping to improve outcomes and reduce mortality.

However, advancing the management of sepsis also means moving away from considering these patients as a homogeneous group. As Ferrer explains, there are very different biological and clinical profiles under the term sepsis: while some patients develop an excessive inflammatory response, others are predominantly affected by a state of immunosuppression, differences that may have important therapeutic implications. For this reason, he states that “sepsis management is clearly moving towards precision medicine”.

In this context, biomarkers will play a role that goes beyond diagnosis. “Rather than looking for a single marker, the future lies in biomarker panels that provide complementary information on inflammation, immune response, organ damage and prognosis,” Ferrer highlights.

Their integration with rapid diagnostic technologies, artificial intelligence and clinical decision-support systems could make it possible to interpret large volumes of data in real time and help healthcare professionals make more precise decisions about hospital admission, treatment intensity or the use of targeted therapies. The ultimate goal, Ferrer concludes, is to move towards “a model in which sepsis will no longer be approached as a single entity, but treated in an increasingly personalised way”.

The Impact of Sepsis on ICUs and Hospital Resources

The impact of sepsis is not limited to its high mortality rate. Its management also represents a significant clinical burden for intensive care units, both because of the number of patients affected and the severity of the conditions they present.

According to Dr. Carlos García-Palenciano, Head of the Anaesthesia and Resuscitation Department at Hospital Virgen de la Arrixaca, approximately 30% of patients treated in an ICU have sepsis, and of these, between 30% and 46% die during their stay in these units. These figures should also be interpreted in light of the fact that the diagnostic criteria for sepsis have changed over time. Therefore, he points out, “if we are less strict in defining sepsis, these figures could be even higher”.

Against this backdrop, early identification once again becomes a key factor. Currently, diagnosis is based on a combination of laboratory tests and clinical observations that, in many cases, emerge when the condition is already advanced. “Early diagnosis facilitates early treatment and increases survival,” García-Palenciano highlights.

This ability to anticipate the disease may also have implications for the use of hospital resources. As the specialist explains, sepsis is a still poorly understood immune mechanism that ultimately causes damage to major organs, the support of which requires considerable use of resources.

From Biomarkers to Precision Medicine in Sepsis

For his part, Dr. Gerardo Aguilar, Head of the Critical Care Unit of the Department of Anaesthesiology and Critical Care at Hospital Clínic Universitari de València, explains that transcriptomics, proteomics and immune cell analysis are making it possible to identify different endotypes associated with severity and prognosis.

In this context, biomarkers can help us understand how each patient’s immune system is responding. “A static biomarker will probably not be enough. We need functional biomarkers and, whenever possible, serial measurements,” says Aguilar. One area of interest is the NLRP3 inflammasome, which is part of the innate immune response and whose dynamics could provide prognostic information.

The aim is to obtain information that can be translated into clinical decision-making: identifying patients at risk of deterioration earlier, monitoring how their immune response evolves and, in the future, selecting treatments according to the predominant biological mechanism.

In this area, INCLIVA is working together with Viva In Vitro Diagnostics to study functional NLRP3 inflammasome activation. For these types of tools to reach clinical practice, Aguilar says it will be necessary to demonstrate “analytical robustness, clinical validity, clinical utility and sufficiently fast and straightforward integration into hospital workflows”. The ultimate goal is to move from treating sepsis as a single syndrome towards an approach tailored to each patient’s specific biological profile.

Biotechnology to Advance Towards a More Personalised Approach

For Toni Vilaplana, CEO of Viva In Vitro Diagnostics, biotechnology can play a key role by developing tools that provide deeper insights into what is happening in each patient. “Precision medicine in sepsis will require biomarkers that not only indicate the presence of infection or inflammation, but also help stratify risk, identify biological profiles and support better clinical decisions,” he explains.

The challenge is to translate these advances from the laboratory into clinical practice. For Vilaplana, this means “turning a promising scientific observation into a robust, reproducible, scalable and useful tool in a real-world clinical setting”. This process requires collaboration between hospitals, clinicians, researchers, regulatory experts and quality systems, as well as scientific validation, clinical and translational studies, technological development, industrialisation and regulatory compliance.

For Viva In Vitro Diagnostics, sepsis represents its first clinical indication for translational validation. The aim, Vilaplana explains, is to generate robust evidence and develop a technology that can “ultimately be integrated into clinical pathways in a useful, safe and sustainable way”.