SEATTLE and BRISBANE, Australia, Jan. 22, 2024 /PRNewswire/ — Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced that data validating the use of SeptiCyte® RAPID in differentiating sepsis from systemic inflammatory response syndrome (SIRS) was selected for presentation on Sunday, January 21, during the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress in Phoenix, Arizona, January 21 to 23, 2024.
Immunexpress Chief Medical Officer Dr. Roy Davis presented the poster entitled, “Accurate Sepsis Identification poster Using SeptiCyte® RAPID & Other Biomarkers of Systemic Inflammation (pdf)” in a Research Snapshot theatre and fielded questions afterward in a Q&A discussion.
“The data demonstrate that no combination of biomarkers outperformed SeptiScore alone, or models including SeptiScore, at identifying sepsis,” said Dr. Roy Davis, MD, PhD, MHA, Chief Medical Officer of Immunexpress. “This is clinically meaningful as it demonstrates that SeptiCyte RAPID can be used to help diagnose sepsis more accurately than current sepsis diagnostic tools or clinical variables. SeptiCyte RAPID isn’t intended to be used as a standalone test, but in this study adding other biomarkers to SeptiScore didn’t appreciably increase the diagnostic certainty of differentiating sepsis from SIRS.”
About the Study
The retrospective and prospective study was conducted at ten hospital sites in the U.S. and Europe. The patient cohort included adult patients who were critically ill and admitted to the Intensive Care Unit (ICU) with a suspicion of sepsis. All patients in the cohort had at least two or more SIRS criteria. The performance of SeptiCyte® RAPID was evaluated relative to other biomarkers commonly evaluated when identifying and managing sepsis.
SeptiCyte® RAPID (SeptiScore®), which measures two immune biomarkers to differentiate sepsis from SIRS, had a mean AUC of 0.85 at distinguishing sepsis from SIRS. Other clinical variables, including PCT, CRP, WBC Min, WBC Max and lactate alone had AUC’s of 0.75, 0.60, 0.60, 0.57 and 0.54 respectively. Use of all five other biomarkers in combination with SeptiScore® had an AUC of 0.85 (95% CI: 0.85-0.86), which was not significantly better than using SeptiScore® by itself to distinguish sepsis from SIRS.
Additional Participation in the 2024 Critical Care Congress
Dr. Davis will also be present in the Member Lounge, for the duration of the conference, to engage with SCCM Members and discuss how SeptiCyte® RAPID aligns with SSC guidelines, CDC Hospital Sepsis Program Core Elements, and CMS SEP-1 bundle compliance.
Additionally, Immunexpress will continue to host an exhibit booth through Tuesday, January 23. The exhibit booth, #928, will provide demonstrations of SeptiCyte® RAPID and discuss recent study findings. Conference attendees are encouraged to visit the booth to learn more about the utility of SeptiCyte® RAPID in emergency care settings. Exhibition times are listed below:
- Monday, January 22, from 8:45 a.m. – 3:30 p.m. MT
- Tuesday, January 23, from 8:45 a.m. – 1:30 p.m. MT
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.
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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Russo Partners, LLC
SOURCE Immunexpress, Inc.