We are pleased to announce that Immunexpress’ SeptiCyte RAPID is now included on the Australian Register of Therapeutic Goods (ARTG) for use in clinical testing of paediatric patients suspected of sepsis.
Paediatric sepsis remains a leading cause of morbidity and mortality in children across Australia, with approximately 500 paediatric ICU admissions and 50 deaths annually. Early recognition and timely identification are critical, as rapid detection can significantly improve outcomes and help prevent progression to life‑threatening organ dysfunction.
SeptiCyte RAPID is a host-response test that distinguishes sepsis from non-infectious systemic inflammation in approximately one hour, supporting faster clinical decisions. Previously validated in adults through multiple peer-reviewed studies, its clinical utility has now been extended to paediatrics.
A recent study conducted in collaboration with the University of Queensland and Seattle Children’s Hospital demonstrated strong performance in critically ill children, distinguishing sepsis from infection‑negative SIRS with an AUROC of 0.83. These findings were presented at the Society of Critical Care Medicine (SCCM) in Orlando, Florida.
We’re excited to introduce this innovation to Australia, supporting clinicians with the first and only blood test designed to aid in the assessment of paediatric sepsis.
SeptiCyte RAPID is available for IVD use in Australia and New Zealand.
References:
1. Tsirtsakis, A. (2025) Diagnostic tool missing 95% of kids hospitalised with sepsis: Study, NewsGP. Available at: https://www1.racgp.org.au/newsgp/clinical/diagnostic-tool-missing-95-of-kids-hospitalised-wi (Accessed: 26 February 2026).
2. Zimmerman, J.J. et al. (2025) ‘2025 Critical Care Congress’, in Diagnosing Pediatric Sepsis With SeptiCyte® RAPID Host Gene Expression. Orlando. Available at: https://septicyte.com/wp-content/uploads/2026/01/Pediatric_SeptiCyte-RAPID-003_Zimmerman.pdf (Accessed: 26 February 2026).
