SEATTLE and BRISBANE, Australia, April 5, 2023 /PRNewswire/ — Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today a poster presentation at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) which evaluates the use of SeptiCyte® RAPID as a tool to determine sepsis status in patients admitted to the Intensive Care Unit (ICU). The poster presentation, entitled “CLARIFYING UNCERTAINTY IN SEPSIS DIAGNOSIS USING A GENE EXPRESSION ASSAY,” #P1673, will be presented in-person at ECCMID on April 16th, 2023, in Copenhagen, Denmark. The poster will be published in the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) e-library and will be available at www.septicyte.com/references.
Additionally, Immunexpress will host a presentation entitled “SeptiCyte RAPID, a unique qPCR host response assay for the rapid and early detection of sepsis,” at the ECCMID Innovation Theatre on April 17th, 2023, at 12:30 p.m. CET. Immunexpress will also provide live demos of SeptiCyte RAPID on Biocartis’ Idylla™ Platform at booth EN-04.
The study evaluated 143 adult patients admitted to the ICU who were classified as indeterminate by an external three-member panel of experienced physicians performing a three-way patient classification of sepsis, systemic inflammatory response syndrome (SIRS), or indeterminate by chart review using retrospective physician diagnosis (RPD) The 143 patients were derived from a retrospective and prospective clinical trial comprising critically ill adult patients admitted to the ICU with a suspicion of sepsis (MARS-NCT01905033, NEPTUNE-NCT05469048) (total n=419). Indeterminate cases occurred when all panelists could not reach SIRS or sepsis consensus. The 143 indeterminate patients included in the study were reviewed again, requiring a final adjudication of SIRS or sepsis performed by forced diagnosis with SeptiCyte RAPID.
For patients initially classified as indeterminate and then reassessed by a forced diagnosis, SeptiCyte RAPID significantly differentiated between SIRS (mean result or SeptiScore® 5.6) and sepsis (mean SeptiScore 7.3) (p=1.31e-07).
“Early identification of sepsis is crucial for improvement in outcomes of sepsis patients. Emergency medical teams are often unable to diagnose sepsis in its early stages since patients present with clinical symptoms that are common to many other non-infectious diseases,” said Dr. Balk, Professor of Medicine, Rush Medical College and Rush University Medical Center in Chicago, IL. “SeptiCyte RAPID served as an effective tool to differentiate sepsis-positive cases from SIRS in scenarios in which a clinician panel was unable to determine diagnosis.”
“This study provides evidence that SeptiCyte RAPID has the potential to significantly impact emergency care centers through not only providing rapid, accurate diagnosis of sepsis, but by fostering anti-microbial stewardship,” commented Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress. “Antibiotic overuse is a tremendous challenge for hospitals, as many care teams prescribe these as a treatment in cases in which infection status is unable to be determined. By differentiating sepsis from SIRS, care teams are able to more confidently prescribe antibiotics for sepsis patients as an essential part of their care plan.”
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 organ dysfunction and high infection risk. 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, and Immunexpress has a commercialization partnership with Biocartis in Europe.
SeptiCyte® RAPID is CE Marked as a 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) from infection negative systemic inflammation in patients with organ dysfunction and high-risk infectious exposures. 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.