Journal of Clinical Medicine Publication Demonstrates Clinical Utility of SeptiCyte® RAPID in Critically Ill Heterogeneous Patient Populations

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Oct 16, 2024, 08:00 ET

SeptiCyte® RAPID demonstrated consistent performance in discriminating sepsis from Systemic Inflammatory Response Syndrome (SIRS) regardless of demographics or the presence or absence of medical conditions

SEATTLE and BRISBANE, Australia, Oct. 16, 2024 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostics company focused on improving outcomes for suspected sepsis patients, today announced the publication of a study in the Journal of Clinical Medicine. The article, entitled, "Rapid and Robust Identification of Sepsis Using SeptiCyte RAPID in a Heterogeneous Patient Population," is published in the Special Issue "Sepsis and Organ Dysfunction: New Insights into Diagnosis and Treatment" and may be accessed online.

"Not only did SeptiCyte RAPID consistently discriminate between sepsis and SIRS across races, disparate medical conditions, therapeutic regimens, and source of infection, but it was also able to classify patients into distinct phenotypes by clinical severity. Phenotyping complex patients with sepsis is key to identifying the most appropriate and individualized treatments," commented Gregory Martin, MD, MSc, Distinguished Professor and Director of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, Emory University School of Medicine, Atlanta, GA, and co-author of the publication.

"Patients' pre-existing medical conditions may affect the body's immune response to an infection as well as the clinical parameters that are used to diagnose sepsis. The validity of a diagnostic test for sepsis is dependent on its ability to discern between sepsis and SIRS in these various critically ill patient populations, including immunocompromised patients and those with cancer," commented Roy Davis, MD, PhD, MHA, Chief Medical Officer of Immunexpress.

SeptiCyte® RAPID performance was largely unaffected by key variables associated with heterogeneity in patients suspected of sepsis (n=419), including those from different racial groups and underlying disease states. SeptiCyte RAPID was effective in identifying septic shock in both Black patients (AUC 0.96) and White patients (AUC 0.83). No significant difference in SeptiCyte RAPID performance was observed based on the presence or absence of hyperglycemia, impaired immunity, hypertension, cardiovascular disease, kidney disease, cancer, or obesity.

Two to three distinct patient subgroups were observed in sepsis patients (n=176) using unsupervised learning methods. One subgroup appeared to be mainly populated by patients exhibiting more severe sepsis, including septic shock. Two to three distinct patient subgroups were observed in the entire study, sepsis or SIRS cohort (n=419). SeptiCyte RAPID exhibited consistently strong performance (AUC 0.79-0.89) across subgroups in both sepsis and SIRS patients. Phenotypic stratification may be useful for categorizing sepsis patients into subgroups based on clinical severity, which in turn may inform the appropriate therapeutic interventions.

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:

Scott Stachowiak
Russo Partners, LLC
[email protected]

Maddie Stabinski
Russo Partners, LLC
[email protected]

SOURCE Immunexpress, Inc.