Rapid Sepsis Test Enables Hospital to Reduce Mortality by 42% and Shorten Hospital Stay by Two Days, According to Academic Medical Center Study

Froedtert Hospital results reinforce growing real-world evidence that IntelliSep^® is a transformative tool for suspected infections in emergency departments

SAN FRANCISCO and ANAHEIM, Calif., Dec. 10, 2025 /PRNewswire/ -- A new study from Froedtert Hospital, an academic medical center in Milwaukee, shows that patients with suspected infection who received the IntelliSep^® rapid sepsis test had 42% lower mortality and spent nearly two fewer days in the hospital compared with those who were not tested. These findings, presented this week at the IHI Forum 2025, are consistent with previously published peer-reviewed evidence performed at multiple health systems across diverse emergency department (ED) settings, highlighting IntelliSep's ability to aid physicians in their diagnosis and improve outcomes for patients.

Sepsis contributes to one in three hospital deaths annually and is the most costly condition to treat. Early detection remains a persistent challenge because symptoms often mimic a wide range of other conditions, including critical emergencies such as cardiogenic shock. IntelliSep provides clinicians an objective measure of immune dysregulation, the core driver of sepsis. The lab test delivers results in eight minutes, enabling clinicians to rapidly risk stratify patients at triage to accelerate care for high-risk patients and avoid unnecessary interventions in lower-risk cases.

"Making the diagnosis of sepsis can be hard, especially in the emergency department where quick decisions have to be made without all of the information one might want. We believe that the IntelliSep test gives physicians more confidence in diagnosing or ruling out sepsis and can help with resource utilization," said study author Thomas Carver, MD, FACS, Professor of Surgery and Senior Medical Director of Critical Care Services at the Medical College of Wisconsin. "The findings on the use of IntelliSep in our ED provided real-world evidence that this test can help clinicians make more informed decisions that improve patient outcomes."

Key Findings
The study was performed at Froedtert Hospital, part of the Froedtert & the Medical College of Wisconsin health network and the region's only Adult Level 1 Trauma Center. Between August 2024 and May 2025, researchers evaluated 6,040 ED patients with suspected infection. After adjusting for baseline clinical differences through propensity matching, which mimics a randomized study, the team assessed the impact of IntelliSep on clinical decision making, comparing patients tested with IntelliSep to those who were not. Key findings include:

• Hospital length of stay (HLOS) was approximately two days shorter for those tested with IntelliSep.
  • Overall HLOS was 1.9 days shorter
  • Septic patients' HLOS was 2.2 days shorter
  • Non-septic patients' HLOS was 1.7 days shorter
    
    
• Mortality rates were 42% lower among patients who were tested with IntelliSep.
  • Overall mortality rate was 42% lower
  • Septic patients had a 35% lower mortality rate
  • Non-septic patients had a 43% lower mortality rate

With these results at Froedtert Hospital, the Froedtert & the Medical College of Wisconsin health network is taking formal steps to expand adoption of IntelliSep across the health system.

Improved Patient Outcomes Demonstrated Across Multiple Health Systems
The findings presented today reinforce previously published data from a peer-reviewed study performed at Our Lady of the Lake Regional Medical Center in Baton Rouge, La. Following more than 12,000 patients over 12 months, the study showed that IntelliSep was associated with a 0.76-day reduction in HLOS and a 39% reduction in mortality rates for sepsis patients.

"These results highlight IntelliSep's repeatable impact on both clinical and operational outcomes across distinct patient populations," said Ajay Shah, Ph.D., Co-Founder and CEO of Cytovale. "Even when physicians used the test at their discretion, without a strict protocol, IntelliSep aided clinical decision making, resulting in significantly better patient outcomes. This demonstrates IntelliSep's practical value in everyday clinical use, empowering hospitals with a trusted tool to make faster, more informed decisions that save lives and optimize resources."

IntelliSep is currently deployed across five states and has been used by hundreds of clinicians to test over 60,000 patients.

For more details on the latest research, download the IHI Forum poster presentation: Impact of Host Response Sepsis Diagnostic Implementation on Length of Stay and Mortality in an Emergency Department.

About Sepsis
Sepsis is a life-threatening condition in which the body mounts an extreme, dysregulated response to infection, leading to widespread inflammation, tissue damage and potential organ failure. In the U.S., sepsis affects more than 1.7 million people each year and is responsible for at least 350,000 deaths annually. Sepsis also carries a high economic burden and the average cost for acute care for sepsis in the U.S. is over $62 billion.

About IntelliSep^®
IntelliSep is Cytovale's U.S. Food and Drug Administration-cleared rapid sepsis diagnostic, the only sepsis diagnostic approved for use in the Emergency Department (ED). IntelliSep leverages artificial intelligence (AI) and advanced microfluidics to provide ED clinicians with an objective and highly sensitive early detection tool for sepsis. IntelliSep assesses the body's dysregulated immune system response to infection and provides a risk score for sepsis within approximately eight minutes using a standard blood draw. For more information, visit cytovale.com/our-solution/intellisep-sepsis-test/.

About Cytovale^®
Cytovale is committed to improving patient care by pioneering early detection technologies that assess immune activation to accelerate the time it takes to get from triage to life-saving therapies. Cytovale developed IntelliSep^®, the U.S. Food and Drug Administration-cleared rapid sepsis diagnostic for use with a standard blood draw in Emergency Departments to determine risk of sepsis. Cytovale is based in San Francisco and venture-backed by Norwest Venture Partners, Sands Capital and Global Health Investment Corporation (GHIC). For more information, visit cytovale.com and follow Cytovale on LinkedIn and X.

SOURCE Cytovale