Data Presentation at Association for Molecular Pathology 2023 Validates Performance of SeptiCyte® RAPID in Immunocompromised Patients and Patients on Immunosuppressive Therapy
17 Nov 2023
Clinical ResultClinical Study
SeptiCyte® RAPID may aid clinicians in determining early antibiotic administration and in bundle compliance for immunocompromised patients with intermediate-high and high probabilities of sepsis
SEATTLE and BRISBANE, Australia, Nov. 17, 2023 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostics company focused on rapid diagnosis and improved outcomes for suspected sepsis patients, today announced a poster presentation validating the utility of SeptiCyte® RAPID in patients who are immunocompromised or are receiving immunosuppressive therapy at the Association for Molecular Pathology (AMP) 2023 Annual Meeting. The poster, entitled "Performance of SeptiCyte® RAPID for Determining Probability of Sepsis in Immunocompromised Patients or Those on Immunosuppressant Therapy," is designated as Poster # ID042 and will be presented on November 17, from 9:15- 10:15 a.m. MT, in Salt Lake City, Utah.
The study compared SeptiCyte RAPID scores with a Retrospective Physician Diagnosis (RPD) across 419 patients to evaluate the efficacy of SeptiCyte RAPID in determining sepsis diagnosis among patients who were immunocompromised or taking immunosuppressive therapy. The study was conducted in collaboration with the Center of Experimental and Molecular Medicine (CEMM), in Amsterdam, Netherlands, and with Rush University Medical Center in Chicago, IL.
"SeptiCyte RAPID was effective in determining the likelihood of sepsis diagnosis among a retrospective cohort of patients regardless of immunocompromised status or immunosuppressive therapy administration. Performance of SeptiCyte RAPID was not affected by fluctuations in white blood cell count," said Robert A. Balk, MD Professor of Medicine Rush University Medical Center and Rush Medical College.
"Patients who are immunocompromised or undergoing immunosuppressive therapy are at an increased risk of developing infections and often have abnormal white blood cell counts. Clinicians experience difficulties in diagnosing sepsis in this subset of patients using traditional diagnostic approaches. SeptiCyte RAPID measures changes in gene expression in whole blood to determine the probability of sepsis and is not affected by fluctuations in the number of white blood cells. This study demonstrates the validity of SeptiCyte RAPID in patients with intermediate-high and high probabilities of sepsis irrespective of immunocompromised status," commented Dr. Richard Brandon, Chief Scientific Officer at Immunexpress.
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, 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.
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.
For more information, visit http://www.septicyte.com and http://www.immunexpress.com/. Follow Immunexpress on Twitter and LinkedIn.
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Russo Partners, LLC
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Maddie Stabinski
Russo Partners, LLC
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SOURCE Immunexpress, Inc.
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