Immunexpress’ Sepsis Test Receives Regulatory Clearance from Australian Therapeutic Goods Administration (TGA) for Paediatric Patients Suspected of Sepsis
SeptiCyte RAPID® is the 1st and only test included in the ARTG for paediatric sepsis testing, which makes it a game changer in the battle against a life-threatening condition
SEATTLE and BRISBANE, Australia, January 20 2026 – Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced that they have received ARTG inclusion for their In Vitro Device, (IVD), SeptiCyte RAPID for use in testing of paediatric patients suspected of sepsis. SeptiCyte RAPID is a host response test to differentiate sepsis from noninfectious systemic inflammation (SIRS) in one hour with high accuracy in adults suspected of sepsis, now has supporting data for use in paediatric patients suspected of sepsis. SeptiCyte RAPID technology was originally developed in Australia and funded in large part by Brian Flannery’s family fund at Ilwella PTY LTD.
A study recently published in the Lancet reported 166 million sepsis cases and 21.4 million sepsis related deaths globally in 2021. Almost half of all cases worldwide occurred in children under five years of age. Paediatric sepsis remains a significant cause of morbidity and mortality in Australia, placing a substantial burden on children, families, and the healthcare system. Paediatric sepsis in Australia is thought to be significantly underestimated with diagnosis varying according to the case criteria applied and because sepsis is hard to diagnose (fever fatigue), mimicking common illnesses making early detection hard. Early recognition and timely treatment are critical, as rapid identification of sepsis markedly improves outcomes and can prevent progression to life-threatening organ dysfunction.
In a recent study conducted with collaborators at the University of Queensland, Brisbane and Seattle Children’s Hospital, Washington, USA SeptiCyte RAPID differentiated critically ill children with sepsis compared to those with infection negative SIRS with strong predictive power (AUROC=0.83). This work was presented at the Society of Critical Care Medicine, (SCCM) in Orlando Florida, February 2025 and can be viewed here.
Dr Adam Irwin, Co-Chair of the Queensland Paediatric Sepsis Program and Associate Professor of Infectious Diseases at the University of Queensland and collaborator in this study commented that “the availability of SeptiCyte RAPID, with a one hour turnaround time, can facilitate identification of sepsis in its early stages when treatment is most effective, even before the onset of organ dysfunction, potentially saving the life of a child”.
The SeptiCyte RAPID test is commercially available to hospitals across Australia, distributed by Abacus Dx, Brisbane, QLD.
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 immunexpress.com and septicyte.com.
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Immunexpress Media Contact:
Matthew Wright Phone:
+61 (0) 451 896 420
Email: matt@nwrcommunications.com.au