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PRESS RELEASE: SeptiCyte RAPID® By Immunexpress Receives Regulatory Clearance from Australian Therapeutic Goods Administration (TGA)

Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced that SeptiCyte® RAPID has received regulatory clearance by the Australian Therapeutic Goods Administration (TGA). The clearance of the company's flagship medical device by the regulatory body allows for the sale, use and further commercial testing of SeptiCyte RAPID throughout Australia to differentiate infection-positive (sepsis) from infection-negative systemic inflammation response syndrome.

"After trialing SeptiCyte RAPID for the past few years, I am looking forward to seeing the impact of this technology in clinical practice," said Associate Professor Adam Irwin, Principal Research Fellow and NHMRC Emerging Leadership Fellow in paediatric infectious disease at The University of Queensland and Queensland Children's Hospital.

"It is especially gratifying to introduce our product to the Australian healthcare community because it was conceived in Australia by Immunexpress' Chief Scientific Officer Dr. Richard Brandon. The ability to bring our sepsis diagnostic capabilities into the Australian healthcare system marks the latest victory in our growing momentum towards impacting patient lives worldwide," said Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress. "Patients suspected of having sepsis need swift, precise diagnostics. There's an urgent need to serve this vulnerable patient group, which has pushed us to continue to revolutionize diagnostic capabilities for their critical care."

SeptiCyte RAPID will be sold across Australia via Abacus Diagnostics, with whom Immunexpress has an executed Distributor Agreement. Abacus Diagnostics also serves as the distributor for the Biocartis Idylla™ Platform in Australia.

About SeptiCyte® RAPID

SeptiCyte® RAPID generates a score (SeptiScore®, 0-15) based on the increasing likelihood of sepsis.  Results are generated in one hour using a small patient blood sample. 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 syndrome in patients with escalating signs and symptoms of critical illness. 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 intended for in-vitro diagnostic use and runs on the Biocartis Idylla™ Platform.

SeptiCyte® RAPID has been FDA cleared for use in hospitalized patients suspected of sepsis since November 2021. 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) (since May 2022.)

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-positive sepsis (bacterial, viral, fungal) 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 identification 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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