2 New Published Studies Highlight SeptiCyte RAPID's Strong Performance and Clinical Utility in Post Cardiac Surgery Patients

SeptiCyte® RAPID scales with other measures of infection and clinical severity and outperforms traditional biomarkers in discriminating infection status

SEATTLE and BRISBANE, Australia, Oct. 23, 2025 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced publication of two studies in the International Journal of Molecular Sciences and Journal of Critical Care that demonstrate the accurate performance of SeptiCyte® RAPID, a sepsis diagnostic to differentiate sepsis from non-infectious systemic inflammation in high risk post cardiac surgery patients. These studies add to the expanding bibliography of SeptiCyte RAPID, which highlights its generalizability across diverse patient populations, including some of the most challenging such as immunocompromised, post high risk abdominal surgery or cardiovascular surgery, nosocomial infections, polytrauma and neutropenic fever.

The first study, "Early Use of Innovative Biomarkers Such as Mid-Regional Pro-Adrenomedullin and SeptiCyte® RAPID in Post-Cardiac Surgery Patients: Pilot Case Series", included cardiac intensive care patients with infective endocarditis (IE) or undergoing elective cardiac surgery at the Città della Salute e della Scienza University Hospital in Turin, Italy. The data indicated an elevated SeptiScore in IE patients which correlated with greater clinical severity, higher Sequential Organ Failure Assessment (SOFA) and Simplified Acute Physiology Score (SAPS), and the need for vasopressor/inotropic support. However,  negative SeptiCyte RAPD results in patients undergoing elective surgery were without risk of complications from infection.

"Our findings show that SeptiCyte® RAPID is a versatile and clinically valuable tool that can help diagnosis sepsis and assess risk in post-operative scenarios following cardiac surgery. Its accuracy, reliability, and speed support its usefulness for both quick decision-making in emergencies and in ongoing patient monitoring over time. While these results are based on a limited series of cases, they provide encouraging evidence that warrants confirmation in a larger population," commented Dr. Giorgia Montrucchio of the Department of Surgical Sciences, University of Turin.

The second study, "Diagnostic performance of SeptiCyte RAPID in critically ill patients with occlusive acute mesenteric ischemia: a pilot study", was a prospective, single-center pilot study in critically ill patients with occlusive acute mesenteric ischemia (OAMI) that were undergoing emergency surgery at Nancy University Hospital, France. A SeptiScore <7.4 perfectly excluded infection (100% negative predictive value), with an area under the curve (AUC) of 0.93 for detecting peritonitis. In contrast, conventional biomarkers (C-reactive protein, procalcitonin) failed to discriminate infection status. Furthermore, a control group of seven patients undergoing elective aortic surgery showed no significant change in SeptiScore, suggesting ischemia alone did not account for the result.

"It is exciting to see continued clinical research such as these recent studies that validates the performance of SeptiCyte® RAPID in differentiating sepsis from bypass induced SIRS in post cardiovascular surgical patients and in a group of patients developing occlusive mesenteric ischemia with secondary sepsis" stated Roy Davis, MD, PhD, MHA, Chief Medical Officer of Immunexpress. "We also see a continued pattern of SeptiCyte RAPID outperforming some traditional biomarkers used for discriminating between sepsis and systemic inflammatory response syndrome, such as procalcitonin and C-reactive protein. These data provide further support for the ability of SeptiCyte RAPID to aid healthcare systems in accurate and timely sepsis diagnosis and antibiotic stewardship."  

About SeptiCyte® RAPID

SeptiCyte® RAPID is a sample-to-answer, cartridge-based, host response molecular test for sepsis using reverse transcription polymerase chain reaction (RT-PCR) to quantify the relative expression levels of host response genes isolated from whole blood. SeptiCyte® RAPID is used in conjunction with clinical assessments, vital signs and laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation response syndromes in patients with escalating signs and symptoms of critical illness. SeptiCyte® RAPID generates a score (SeptiScore®) that falls within four discrete interpretation bands based on the increasing likelihood of sepsis. SeptiCyte® RAPID is intended for in-vitro diagnostic use and runs on the Biocartis Idylla™ Platform.

SeptiCyte® RAPID is CE Marked as a near-patient sample-to-answer test in European Union (EU) member countries and those harmonized with the EU IVD Directive (98/79/EC). As of November 2021, SeptiCyte® RAPID has been FDA cleared for use in hospitalized patients suspected of sepsis.

About Immunexpress

Immunexpress is a molecular diagnostic company, based in Brisbane and Seattle, committed to improving outcomes for patients suspected of sepsis. Immunexpress' SeptiCyte® technology can assess a patient's dysregulated immune response by quantifying and analyzing gene expression from whole blood, providing actionable results in about an hour from sepsis suspicion, to guide the physician in optimizing patient management decisions. SeptiCyte® RAPID is a lab test for sepsis that combines SeptiCyte® technology with the ease-of-use of the revolutionary Biocartis' Idylla™ Platform; it supports differentiating infection (bacterial, viral, fungal) positive sepsis that could lead to organ dysfunction and death from patients with less serious infection negative systemic inflammation. This powerful test enhances early sepsis detection and can strongly support its diagnosis in the crucial first hour(s) that determines clinical outcome. SeptiCyte® RAPID also has a high potential to reduce sepsis associated healthcare costs.

For more information, visit and https://immunexpress.com. Follow Immunexpress on X and LinkedIn. 

Immunexpress Media Contacts:  

David Schull
Russo Partners, LLC
[email protected] 

Rob Haney 
Russo Partners, LLC  
[email protected]  

SOURCE Immunexpress, Inc.