Sepsis causes up to 20,000 annual deaths in Spain: Biotechnology is revolutionizing early diagnosis

Sepsis is a medical emergency that occurs when the body’s response to an infection damages its own tissues and organs, potentially leading to multiple organ failure and death if not treated quickly and appropriately. Globally, according to the World Health Organization (WHO), there are an estimated 48–50 million cases per year, with at least 11 million deaths — one in five deaths worldwide.

In Spain, incidence stands at around 250 cases per 100,000 inhabitants annually, with mortality ranging from 15% to 50%, depending on severity and time to treatment. In absolute terms, sepsis causes between 15,000 and 20,000 deaths per year in Spain — a figure higher than deaths from heart attacks or breast, colon, or pancreatic cancer, and 13 times more than traffic accidents.

One of the main challenges in treating this disease is the lack of targeted therapies beyond antibiotics or surgical removal of the infection source. The incidence and mortality of severe sepsis exceed those of other diseases with major social impact, such as breast cancer or AIDS. Therefore, sepsis remains a great challenge for scientists and clinicians — one in which biotechnology plays a crucial role.

Biotechnology for Early Diagnosis and Risk Stratification

Viva In Vitro, an AseBio member company, is developing a pioneering biotechnology that is revolutionizing sepsis diagnosis: VIVA-ELISA®. This test allows rapid and precise detection of NLRP3 inflammasome activation (indicating patients’ immune system capacity to mount an inflammatory response before clinical symptoms appear) by identifying ASC oligomers as a biomarker.

“This innovative tool provides an assessment of immune response, allowing clinicians to anticipate patients’ response to potential secondary infections and therefore their risk of severe complications in sepsis,” explains Dr. Pablo Pelegrín Vivancos, Professor of Immunology and co-founder of Viva In Vitro.

Unlike traditional methods, VIVA-ELISA enables early and personalized patient stratification, improving prognosis and reducing hospital burden. Currently, the technology has reached TRL4, validated in laboratory settings and ready for clinical trials.

Personalized Medicine and Disruptive Advances

Personalized medicine plays a key role in addressing sepsis due to the disease’s heterogeneity, which makes standard treatments difficult to apply. Viva In Vitro’s tools, including VIVA-ELISA® and Viva Sepscare, enable early identification of NLRP3 inflammasome activation, stratifying patients by risk and immune response. This makes it possible to adapt treatments to each patient, admit them to intensive or critical care when needed, and anticipate complications before they appear clinically.

Viva In Vitro’s most recent milestone has been the development and validation of this innovative biotech device, which combines early prognosis and treatment personalization. In 2025, it was recognized by the European Innovation Council (EIC) as one of Europe’s 40 most disruptive companies. This recognition strengthens the company’s position as a global leader in advanced sepsis diagnostics and immunological medicine, while opening new opportunities to reduce mortality and improve hospital efficiency.

Collaborations, the Biotech Ecosystem, and Remaining Challenges

Viva In Vitro is advancing the development of its sepsis solutions through an extensive network of collaborations with hospitals, research centers, and health services, enabling pre-clinical validation of the NLRP3 biomarker, essential for early diagnosis and patient stratification. Partners include Hospital Universitario Virgen de la Arrixaca (Murcia), Hospital Universitario Virgen de la Victoria (Málaga), Hospital Universitario de Jerez de la Frontera, and Hospital Universitario Vall d’Hebron (Barcelona).

“We are collaborating in the clinical validation of their technology and in quantifying the value it brings to the management of sepsis and severe infections,” says Ricard Ferrer, Head of Intensive Care Medicine at Vall d’Hebron University Hospital.

Regarding the evolution of the biotech ecosystem in Spain against sepsis, Ferrer is optimistic: “There are several innovative initiatives in both diagnosis and treatment. I am convinced some of them will soon translate into real value for patients.”

However, barriers remain to broader adoption of these technologies. Ferrer highlights structural challenges related to funding and business scaling, which are balanced by exceptional opportunities in precision medicine, sustainable biotechnology, and European-international collaboration. Meanwhile, Pelegrín points to practical and regulatory hurdles: “Among the main barriers are healthcare staff’s lack of awareness of new functional biomarkers, the need for clinical validation, and the difficulty of seamless integration into hospital workflows,” as well as the need to overcome regulatory processes such as FDA approval and demonstrate real-world effectiveness.

Together, these collaborations and the strengthening of the biotech ecosystem enable scientific innovation to be transferred into clinical practice. Still, addressing structural and regulatory barriers remains key to maximizing impact for sepsis patients.

Sepsis: Changing Lives in Hours

Sepsis can change lives in just hours, leaving physical, cognitive, and emotional aftereffects for patients and their families. As survivor Marianne Haverkamp shares: “Surviving is only the beginning: afterwards comes a difficult and often lonely stage.”

Early detection and biotechnological innovation — ultrafast diagnosis, personalized medicine, and comprehensive support — are key to saving lives and reducing long-term effects. Her message to society and professionals is clear and direct: sepsis can affect anyone, at any time, and behind each case are people with stories, dreams, and families.

“We cannot allow lives to depend on luck,” Marianne concludes, reminding us of the urgency to act, train specialists, and provide complete recovery programs for patients and families.