Publication in the Journal, Infection, Demonstrates Clinical Utility of SeptiCyte® RAPID for Early Recognition of Sepsis in Patients After Major Abdominal Surgery

SeptiCyte® RAPID results were consistent with retrospective clinical diagnosis of sepsis by blinded experts

SEATTLE and BRISBANE, Australia, Dec. 3, 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 Infection. The article, entitled, "SeptAsTERS- SeptiCyte® RAPID as assessment tool for early recognition of sepsis – a prospective observational study," may be accessed online.

"Using host response assays like SeptiCyte RAPID to detect sepsis is a novel approach for early diagnosis that is not yet widely incorporated in clinical routines of Intensive Care Units. SeptiCyte RAPID results were consistent with post-hoc sepsis diagnosis evaluation by blinded experts in a cohort of post-operative patients recovering from major abdominal surgery," commented Maik von der Forst, MD, Medical Faculty Heidelberg, Department of Anesthesiology, University Hospital Heidelberg, and author of the publication. "The promising results from this study suggest that SeptiCyte RAPID may contribute to a comprehensive point-of-care diagnostic algorithm that includes clinical examination, biomarkers, and microbiological findings to address sepsis."

"This study validates the clinical utility of SeptiCyte RAPID to aid in the swift diagnosis, or ruling out, of sepsis in complex hospitalized patient populations," commented Roy Davis, MD, PhD, MHA, Chief Medical Officer of Immunexpress. "The clinical utility of SeptiCyte RAPID for differentiating sepsis from non-infectious systemic inflammation was not impacted by previous use of antibiotics and the test correlated extremely well with blood culture positivity."  

The study evaluated SeptiCyte® RAPID in a postoperative cohort after major abdominal surgery in a high-level Intensive Care Unit (ICU). SeptiCyte RAPID produced higher mean SeptiScores® for patients categorized as having sepsis by a post-hoc diagnosis from three independent intensive care professionals both within three hours of admission (T0) and 24 hours after admission (T24), regardless of infection source. SeptiScore clearly differentiated patients with sepsis from those with other causes of inflammation, such as surgery, and significantly outperformed other laboratory biomarkers and disease severity scores for negative versus positive blood cultures. Furthermore, SeptiScores had decreased substantially by the time of discharge, especially in sepsis patients, with 75.7% of values in lower SeptiScore bands (Bands 1 and 2).

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.

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Immunexpress Media Contacts: 

Maddie Stabinski
Russo Partners, LLC 
[email protected] 

SOURCE Immunexpress, Inc.