SeptiCyte® RAPID outperformed traditional inflammatory biomarkers of procalcitonin and C-reactive protein
SEATTLE and BRISBANE, Australia, Sept. 17, 2025 /PRNewswire/ — Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced the publication of a study in the journal Infection. The article, entitled, “Blood transcriptomic for the diagnosis of nosocomial infections in critically ill patients: an observational proof-of-concept study,” may be accessed online.
The prospective, observational, non-interventional study evaluated SeptiCyte® RAPID’s ability to discriminate between sepsis and systemic inflammatory response syndrome (SIRS) in critically ill Intensive Care Unit (ICU) patients diagnosed with nosocomial infections compared to traditional inflammatory biomarkers such as procalcitonin and C-reactive protein. The study enrolled 69 patients with ICU-acquired infection confirmed in 50.7% of patients (n=35). Diagnostic capacity was measured with procalcitonin (PCT) with an AUC of 0.600 (95% CI 0.454– 0.745), C-reactive protein (CRP) with an AUC of 0.703 (95% CI 0.564–0.839), and SeptiCyte RAPID with an AUC of 0.995 (95% CI 0.930–1.003). SeptiCyte RAPID yielded a sensitivity of 91.4%, specificity of 73.5%, and positive and negative predictive values of 78% and 89.3% respectively.
“In our study, we evaluated SeptiCyte RAPID for the identification of nosocomial sepsis, which is often difficult to diagnose due to overlapping inflammation from initial pathology, invasive devices, and noninfectious complications. Gene host response assessment proved effective in detecting sepsis in critically ill patients with nosocomial infections,” commented Paula Ramírez Galleymore, MD, Hospital Universitario y Politécnico de la Fe and Former President of the Scientific Committee of the Spanish Society of Intensive Care, Critical Care and Coronary Care Units (SEMICYUC). “Notably, 67.6% of patients without confirmed infections were initially treated with antimicrobials, suggesting SeptiCyte RAPID could help reduce unnecessary antimicrobial use.”
“Given its rapid turnaround time and objective output of SeptiScore, SeptiCyte RAPID may support antibiotic stewardship by guiding decisions regarding the initiation, escalation, or withholding of antimicrobials,” commented Roy Davis, MD, PhD, MHA, Chief Medical Officer of Immunexpress. “SeptiCyte RAPID outperformed traditional biomarkers of procalcitonin and C-reactive protein in discriminating between sepsis and systemic inflammatory response syndrome in a difficult-to-diagnose population. These data support the adoption of SeptiCyte RAPID by healthcare systems with critically ill patients who are at risk of developing nosocomial infections as well as sepsis.”
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 Twitter and LinkedIn.
Immunexpress Media Contacts:
David Schull
Russo Partners, LLC
[email protected]
Maddie Stabinski
Russo Partners, LLC
[email protected]
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SOURCE Immunexpress, Inc.
