Rapid Sepsis Test Reduces Mortality, Shortens Hospital Stay

Patients with suspected infection who received the IntelliSep rapid sepsis test (Cytovale) had a 42% lower mortality rate and were discharged nearly two days sooner compared with those who were not tested, according to a presentation at the IHI Forum 2025, in Anaheim, California.

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 I Trauma Center, in Milwaukee. Between August 2024 and May 2025, researchers evaluated 6,040 emergency department (ED) patients with suspected infection. Both nurses and physicians could order the test if a patient presented with a suspected infection based on certain parameters, such as fever.

Early detection remains a persistent challenge because symptoms often mimic a range of other conditions, including critical emergencies such as cardiogenic shock. IntelliSep provides an objective measure of immune dysregulation, the core driver of sepsis. The 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 low-risk cases.

Once results were obtained, patients were treated based on whether they were critically ill, at risk of developing sepsis, or in critical condition.

After adjusting for baseline clinical differences through propensity matching, which mimics a randomized study, the team assessed the effect of IntelliSep on clinical decision-making, comparing patients tested with those who were not. Key findings include:

• Overall, hospital length of stay (LOS) was 1.9 days shorter, but some patients saw greater results with those who were septic having a hospital LOS 2.2 days shorter versus 1.7 days shorter for non-septic patients.
• Overall mortality rates were 42% lower among patients who were tested, but those who were septic had a 35% lower mortality rate.

With these results, the regional health network is taking formal steps to expand adoption of IntelliSep across its health system, according to the researchers.

In the United States, 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 of acute care for sepsis in the United States is more than $62 billion.

"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," study author Thomas Carver, MD, FACS, a professor of surgery and the senior medical director of critical care services at the Medical College of Wisconsin, said in a press release. "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."

The findings reinforce previously published data from a peer-reviewed study performed at Our Lady of the Lake Regional Medical Center, in Baton Rouge, Louisiana. Following more than 12,000 patients over 12 months, the study showed that IntelliSep was associated with a 0.76-day reduction in hospital LOS and a 39% reduction in mortality rates for patients with sepsis.
IntelliSep is the only sepsis diagnostic cleared for use in the ED. Leveraging artificial intelligence and advanced microfluidics, the test can 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.

"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," Ajay Shah, PhD, the co-founder and CEO of Cytovale, said in the press release.

Based on a press release.