Independent Studies Presented at ESCMID Global Demonstrate the Clinical Utility of SeptiCyte® RAPID in Patients Suspected of Sepsis, Including in Polytrauma Patients

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Apr 17, 2024, 08:00 ET

SeptiCyte^® RAPID accurately differentiated between nosocomial infections and systemic inflammatory response syndrome in polytrauma ICU patients suspected of sepsis.
SeptiScore^®was elevated in ICU patients suspected of sepsis when a causative pathogen was identified.

SEATTLE and BRISBANE, Australia, April 17, 2024 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced the presentation of two posters evaluating SeptiCyte^® RAPID at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) 2024, to take place from April 27 – 30 in Barcelona, Spain.

A Nantes University poster #P3895 entitled, "SeptiCyte RAPID, a new biomarker for the diagnosis of ventilator-associated pneumonia in polytrauma patients," will be presented on April 27, at noon CET.

"Nosocomial infection, especially ventilator-associated pneumonia, is a frequent occurrence for mechanically ventilated trauma patients that is difficult to diagnose and requires swift clinical decision-making. The data demonstrate that SeptiCyte RAPID has potential clinical utility to differentiate between systemic inflammatory response syndrome and nosocomial infection in less than an hour from a simple blood draw, providing actionable information for clinicians of this high-risk patient population," commented the poster presenter Dr. Lisa Neutre, Interne d'Anesthésie - Réanimation at Nantes Université, in Nantes, France.

Samples were collected from 75 adult trauma patients in the intensive care unit (ICU) having systemic inflammatory response syndrome (SIRS) or suspected nosocomial infection. Samples were evaluated using SeptiCyte RAPID and compared to a standard clinical evaluation by a blinded physician in the ICU. The SeptiScore^® was significantly higher in patients with ventilator-associated pneumonia (VAP) or another form of nosocomial infection. The median SeptiScore in patients with VAP was 8.20 (7.20; 8.80), while the median SeptiScore in patients without VAP or nosocomial infection was 5.70 (5.03; 6.70), p<0.001. SeptiCyte RAPID performance for the diagnosis of VAP or nosocomial infection had area under the ROC curve (AUC) value 0.83 (95% Cl 0.72-0.90). SeptiCyte RAPID differentiated between trauma patients with VAP or another form of nosocomial infection and those with non-septic SIRS.

A University of Saarland poster #P0959 entitled, "Prospective evaluation of the SeptiCyte^® RAPID assay for the identification of systemic infectious diseases in patients with suspected sepsis," will be presented on April 28, at noon CET.

"Diagnosing sepsis and prescribing a course of treatment is particularly challenging in patients when it is unknown if a causative pathogen is present. SeptiCyte RAPID not only accurately differentiated between sepsis and systemic inflammatory response syndrome in patients with and without an identified pathogen, but it also helped discriminate between patients with an identified causative agent and those without. This may aid clinicians in recommending the appropriate treatment regimen, including the use of antibiotics," commented the poster presenter Prof. Sören Becker, from the Institut für Medizinische Mikrobiologie und Hygiene, Universitätsklinikum des Saarlandes, Homburg, Germany.

Samples were collected from 28 patients suspected of sepsis and receiving anti-infective treatment in the ICU. In patients with suspected sepsis, those with an identified causative agent had higher SeptiScores than those without. The data warrant further analysis to evaluate the diagnostic accuracy of SeptiCyte RAPID for differentiation of individuals with an infectious etiology from those with other causes.

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 https://septicyte.com and https://immunexpress.com. Follow Immunexpress on Twitter and LinkedIn.

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SOURCE Immunexpress, Inc.