The eight-minute test also shortened hospital stays by nearly two days at Froedtert Hospital, reinforcing previous multi-site evidence.
A study from Froedtert Hospital 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.
The findings, presented at the IHI Forum 2025, evaluated 6,040 emergency department patients with suspected infection between August 2024 and May 2025 at the Milwaukee academic medical center. After adjusting for baseline clinical differences through propensity matching, researchers compared outcomes between patients tested with IntelliSep and those who were not.
Key findings include:
- Hospital length of stay 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
IntelliSep provides clinicians an objective measure of immune dysregulation and delivers results in eight minutes using a standard blood draw. The FDA-cleared test is currently the only sepsis diagnostic approved for use in emergency departments.
“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,” says study author Thomas Carver, MD, professor of surgery and senior medical director of critical care services at the Medical College of Wisconsin, in a release.
Results Mirror Previous Multi-Site Evidence
The Froedtert Hospital findings reinforce previously published data from Our Lady of the Lake Regional Medical Center in Baton Rouge, Louisiana. That peer-reviewed study, which followed more than 12,000 patients over 12 months, showed IntelliSep was associated with a 0.76-day reduction in hospital length of stay and a 39% reduction in mortality rates for sepsis patients.
Sepsis contributes to one in three hospital deaths annually and is the most costly condition to treat in the US. Early detection remains challenging because symptoms often mimic other conditions, including critical emergencies such as cardiogenic shock.
The test leverages artificial intelligence and advanced microfluidics to assess the body’s dysregulated immune system response to infection, providing a risk score for sepsis within approximately eight minutes.
Expanding Adoption Across Health Systems
Based on the study results, the Froedtert & the Medical College of Wisconsin health network is taking formal steps to expand adoption of IntelliSep across the health system.
“These results highlight IntelliSep’s repeatable impact on both clinical and operational outcomes across distinct patient populations,” says Ajay Shah, PhD, co-founder and CEO of Cytovale, which developed the test, in a release. “Even when physicians used the test at their discretion, without a strict protocol, IntelliSep aided clinical decision making, resulting in significantly better patient outcomes.”
IntelliSep is currently deployed across five states and has been used by hundreds of clinicians to test over 60,000 patients. In the US, sepsis affects more than 1.7 million people each year and is responsible for at least 350,000 deaths annually, with average acute care costs exceeding $62 billion.
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