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| Image created by Dr. Michael J. Miller |
Immunexpress, Pty Ltd, a molecular diagnostic company founded in Brisbane, today announced that the SeptiCyte® RAPID test will be evaluated in the diagnosis of paediatric sepsis in Queensland children.
The testing is in part funded through a Federal Government's Medical Research Future Fund Genomic Health Futures Mission grant for collaborative work between The University of Queensland and Immunexpress. One of the keys to the successful development of the SeptiCyte technology has been early investment funding through the foresight of Brian Flannery (Ilwella family office), and Australian Federal Government commercialization grants.
The work will be led by the paediatric sepsis research team working with Associate Professor Luregn Schlapbach (Child Health Research Centre - The University of Queensland) and Dr. Richard Brandon (co-founder and Chief Scientific Officer of Immunexpress) and will involve SeptiCyte® RAPID testing on a near-patient testing platform (Biocartis Idylla™). From a small blood sample, and within approximately one hour, SeptiCyte® RAPID provides a probability of sepsis in children presenting with clinical signs of systemic inflammation, such as fever or rapid breathing.
"Immunexpress was founded in Queensland and now SeptiCyte technology is coming home," said Dr. Brandon. "SeptiCyte LAB was FDA cleared for use in adults, while the fully automated 2nd generation product, SeptiCyte RAPID is CE marked and it is now important that we demonstrate clinical utility of SeptiCyte RAPID in children. Our collaboration with The University of Queensland is providing us with this opportunity."
Associate Professor Schlapbach said, "The results of the collaborative work will help save the lives of critically-ill children by improving diagnosis of sepsis using genomic technology. Early and accurate diagnosis of sepsis is crucial in successful management of these patients." Sepsis remains a leading cause of mortality in children worldwide.
About SeptiCyte® RAPID
SeptiCyte® RAPID is a gene expression assay discovered and patented from Australia, which uses reverse transcription polymerase chain reaction (PCR) to quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene® Blood RNA Tube. 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 in patients suspected of sepsis. SeptiCyte® RAPID generates a score (SeptiScore®) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte® RAPID is intended for in-vitro diagnostic use and is used on the Biocartis Idylla™ System.
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). SeptiCyte® LAB was FDA cleared in 2019. Australian TGA registration is expected later in 2021.