New Sepsis Test Slashes Mortality, Proves Scalable in Major Study

CHICAGO, IL – March 23, 2026 – A groundbreaking rapid diagnostic for sepsis is demonstrating consistent, life-saving results across multiple hospitals, suggesting a new standard of care may be on the horizon for one of medicine’s deadliest and most elusive conditions. New data presented today at the Society of Critical Care Medicine's (SCCM) 2026 Critical Care Congress reveals that widespread implementation of Cytovale's IntelliSep test was associated with a 19% relative reduction in sepsis mortality across a large health system.

The multicenter study, which analyzed outcomes for over 34,000 emergency department patients with suspected infections, validates that the dramatic clinical and operational gains first seen at a single high-volume medical center can be successfully replicated in diverse hospital environments, from major tertiary care facilities to smaller community hospitals.

A Replicable Blueprint for Combating Sepsis

Sepsis, the body’s overwhelming and life-threatening response to an infection, is notoriously difficult to diagnose in its early stages. Its symptoms can mimic many other conditions, leading to critical delays in treatment. For every hour that treatment is delayed, the risk of death increases significantly. The new study on the IntelliSep test, conducted within the Franciscan Missionaries of Our Lady (FMOL) Health system, offers compelling evidence that this diagnostic uncertainty can be substantially reduced.

Following a successful initial implementation at Our Lady of the Lake Regional Medical Center (OLOLRMC), the health system expanded the use of the IntelliSep test to four additional hospitals. The results were remarkably consistent. Across the board, hospitals saw a 19% drop in sepsis-related deaths. The findings also pointed to a significant improvement in diagnostic accuracy: mortality among patients who were suspected of sepsis but ultimately found to have other conditions dropped by 22%. This suggests that by quickly ruling out sepsis, clinicians were able to pivot faster to identify and treat the true underlying illness.

"After a peer-reviewed study of our initial implementation at Our Lady of the Lake Regional Medical Center (OLORMC) showed the real-world impact of IntelliSep, we were confident that we wanted to expand the use of the test at other hospitals in our health system," said Christopher Thomas, MD, Chief Quality Officer at FMOL Health. "What's most compelling about this new data is how consistently those clinical and operational improvements appeared across every participating hospital, from large tertiary centers to community hospitals. IntelliSep demonstrated that it can scale across any environment with repeatable, meaningful impact, giving clinicians faster, more accurate insight when evaluating patients for sepsis."

From Single Success to System-Wide Standard

The significance of the new findings lies in its demonstration of scalability. While impressive results at a single, well-resourced academic center are noteworthy, the true test of a medical innovation is its performance in the varied, real-world settings where most patients receive care. The FMOL Health study provides this validation.

The expansion initiative included a diverse portfolio of facilities: St. Elizabeth Hospital, a 78-bed community hospital; Our Lady of Lourdes Regional Medical Center, a 340-bed hospital; St. Francis Medical Center, a 330-bed Level 3 trauma center; and St. Dominic Hospital, a 570-bed tertiary care hospital. The consistent outcomes across these different environments underscore the technology's robustness.

At St. Francis Medical Center, the tool's impact was felt directly in the emergency department. "At St. Francis Medical Center, IntelliSep has strengthened early decision‑making and improved both ED discharges and blood culture utilization," noted John Bruchhaus, MD, the hospital's Chief Medical Officer. "IntelliSep has decreased our diagnostic utilization costs while improving mortality and decreasing length of stay at our facility. It has become a vital tool in our everyday practice when treating sepsis."

This sentiment highlights a crucial aspect of the test's value: it doesn't just improve a single metric, but rather a cascade of interconnected clinical and operational outcomes.

The Economic Case for Faster, Smarter Diagnosis

Beyond the profound clinical benefit of saving lives, the widespread adoption of IntelliSep within the FMOL Health system has illuminated a powerful economic argument for the technology. In an era of strained hospital budgets and overcrowded emergency rooms, efficiency is paramount. The study reported a 20% increase in patients being discharged directly from the emergency department, a key indicator of improved patient flow and resource management. Importantly, this was achieved with no corresponding increase in seven-day revisit rates, confirming that these discharge decisions were clinically sound.

Furthermore, the test drove a significant 30% reduction in the use of blood cultures, a traditional but slow diagnostic tool. This reduction was concentrated among patients who were ultimately not diagnosed with sepsis, demonstrating a more intelligent and targeted use of laboratory resources. Meanwhile, blood culture utilization remained high (over 90%) for patients who were confirmed to have sepsis, ensuring that comprehensive diagnostic workups were still performed on high-risk individuals.

This optimization of resources translates directly to the bottom line. Data from the initial implementation at OLOLRMC had already shown an average cost savings of $1,429 per patient and a reduction in hospital length of stay by nearly a full day for sepsis patients. The new multicenter data confirms that these financial and operational benefits are not an anomaly but a predictable outcome of integrating the rapid diagnostic into standard care protocols. This also helps hospitals better meet the stringent requirements of the Centers for Medicare & Medicaid Services (CMS) SEP-1 quality measure, which can have its own financial implications.

Reshaping Decisions with an 8-Minute Result

The IntelliSep test represents a fundamental shift in sepsis diagnostics. Instead of searching for a specific pathogen, which can be like finding a needle in a haystack, the test assesses the body’s own immune response. Using a standard blood draw, the platform leverages advanced microfluidics and machine learning to analyze the biophysical properties of white blood cells. Within approximately eight minutes, it provides clinicians with an objective risk score, categorizing patients into low, intermediate, or high probability of sepsis.

This speed and novel approach provide actionable information at one of the most critical moments in a patient's journey: triage. It gives emergency department staff a powerful tool to cut through the ambiguity of early-stage infection symptoms. A low-risk score can give a clinician confidence to explore other diagnoses, while a high-risk score can trigger immediate, life-saving sepsis protocols.

As the first and only diagnostic of its kind to be cleared by the U.S. Food and Drug Administration specifically for aiding early sepsis detection in the emergency department, IntelliSep is carving out a new space in emergency medicine. The robust, real-world evidence from the FMOL Health system provides a compelling case that its benefits—fewer deaths, improved efficiency, and reduced costs—are not just possible, but repeatable on a system-wide scale.