Immunexpress to Present Data at ISICEM 2023 Indicating that SeptiCyte® RAPID Outperforms Other Rapid Measures for Sepsis Diagnosis

• SeptiCyte RAPID® more accurately determined sepsis status in patients admitted to the ICU in comparison to other rapid diagnostic methods, including quick Sequential Organ Failure Assessment (qSOFA)
  
  
• SeptiCyte RAPID together with qSOFA was statistically significant at distinguishing both higher and lower mortality sepsis patients in the ICU cases from those without sepsis and may have utility as the first step in diagnostic pathways for sepsis

SEATTLE and BRISBANE, Australia, March 21, 2023 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today a poster presentation at the 2023 International Symposium on Intensive Care and Emergency Medicine (ISICEM) which evaluates the use of SeptiCyte® RAPID as a tool to determine sepsis status in patients admitted to the ICU (Intensive Care Unit), in comparison to other methods. The poster presentation, entitled "Performance of a Molecular Host Response Assay in Patients Suspected of Sepsis and Stratified by qSOFA," will be presented on March 21, 2023. The abstract will be published in Critical Care Medicine and will be available at www.septicyte.com/references.

The study was conducted using retrospective and prospective data from clinical trials (NCT01905033, NCT02127502, NCT05469048) involving 419 critically ill patients with systemic inflammatory response syndrome who had been admitted to the ICU under suspicion of having sepsis. Expert diagnosis was performed by a panel of three clinicians who classified patients as sepsis positive, sepsis negative or indeterminate, and a full quick Sequential Organ Failure Assessment (qSOFA) score was calculated for 173 patients.

SeptiCyte® RAPID differentiates sepsis positive patients from sepsis negative patients irrespective of qSOFA stratification (AUC 0.82 in qSOFA ≥2, AUC 0.81 in qSOFA < 2) and outperformed other conventional rapid diagnosis methods such as SOFA, lactate, PCT, among other parameters. SeptiCyte RAPID outperformed other markers of sepsis at separating both higher and lower mortality ICU cases from patients that did not have sepsis.

"Identifying the systemic inflammatory response is not enough to diagnose and to determine the outcome in sepsis positive cases, as inflammation and other parameters are a clinical attribute of a variety of diagnoses, including systemic inflammatory response syndrome (SIRS). This study provides evidence that the SeptiCyte RAPID molecular assay has utility early in the diagnostic pathway for sepsis, with qSOFA and SOFA scores subsequently used to help  determine the likelihood of poor outcomes, such as  septic shock and mortality in patients diagnosed with sepsis using the Sepsis-3 definition," noted Dr. Balk, [Professor of Medicine, Rush Medical College and Rush University Medical Center in Chicago, IL).

"This study demonstrates that SeptiCyte RAPID is not only a more accurate sepsis diagnostic tool compared to other conventional rapid diagnosis methods but can serve as a crucial first step in the diagnostic and treatment paradigm for patients suspected of sepsis using the Sepsis-3 framework. While conventional sepsis diagnosis is based on parameters such as qSOFA, PCT, lactate, white cell count, respiratory rate and temperature, SeptiCyte RAPID measures the mRNA expression of two genes that are specific to sepsis," commented Dr. Richard Brandon, Chief Scientific Officer of Immunexpress. "Emergency medicine outcomes rely on quick decision-making and action. SeptiCyte RAPID is uniquely positioned to provide clinicians in this field with actionable results in less than an hour and may be utilized early in the diagnostic pathway to determine the likelihood of sepsis. In conjunction with additional parameters of qSOFA and SOFA scores, SeptiCyte RAPID may aid clinicians in predicting the likelihood of septic shock or other unwanted health outcomes."

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 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) 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. 

For more information, visit http://www.septicyte.com and  http://www.immunexpress.com/. Follow Immunexpress on Twitter and LinkedIn. 

Scott Stachowiak
Russo Partners, LLC
[email protected]

Maddie Stabinski
Russo Partners, LLC 
[email protected]

SOURCE Immunexpress, Inc.