Immunexpress Announces U.S. FDA Clearance of EDTA Blood Compatible Cartridges for SeptiCyte RAPID®

EDTA blood collection tubes are used routinely in clinical settings for hematology procedures around the world

SEATTLE and BRISBANE, Australia, Jan. 4, 2024 /PRNewswire/ — Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the clearance of EDTA blood compatible cartridges by the U.S. Food and Drug Administration (FDA) for use with SeptiCyte RAPID®. The updated SeptiCyte® RAPID cartridges add undiluted EDTA blood as a validated sample type within the U.S. healthcare market and have been available on the European market since August 2022.

“As an investigator in the U.S. clinical validation study of EDTA cartridges with SeptiCyte RAPID, my team appreciates how this sample collection will increase the utility of SeptiCyte RAPID,” commented Kenneth E. Remy, MD, MHSc, MSCI, FCCM, Center Director, the Blood, Heart, Lung, and Immunology Research Center and the Ellery Sedgwick, Jr. Chair and Distinguished Scientist in Cardiovascular Research at University Hospitals and UH Rainbow Babies & Children’s in Cleveland/Case Western Reserve University. “Sepsis is a condition that rapidly progresses, and early diagnosis has the potential to influence patient outcomes. EDTA-anticoagulated blood samples broaden the ability to utilize available clinical samples in at-risk patients for faster collection and processing of patient samples so clinicians may make actionable decisions for the course of care of suspected sepsis patients.”

“The ability to utilize undiluted EDTA blood samples with SeptiCyte RAPID in the U.S. healthcare system will improve ease-of-use in the clinical setting,” said Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress. “The updated SeptiCyte® RAPID EDTA cartridges add additional utility to our diagnostic technology by allowing the use of small volumes of blood with minimal processing required and will promote wider adoption in healthcare systems across the U.S.”

The EDTA cartridges were previously validated in a multi-site study conducted at University Hospitals in Cleveland/Case Western Reserve University and other healthcare systems. Their implementation allows for the use of standard EDTA blood collection tubes in place of proprietary PAXgene® blood RNA tubes.

This research was in part funded by Contract #75A50120C00125 from the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). BARDA awarded this grant to Immunexpress in 2020 as part of the DRIVe Solving Sepsis program.

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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Media Contacts:

Scott Stachowiak
Russo Partners, LLC

Maddie Stabinski
Russo Partners, LLC

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