SeptiCyte® RAPID, an in vitro diagnostic test intended to aid differentiating infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis, demonstrated good analytical performance
SEATTLE and BRISBANE, Australia, July 25, 2023 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today a poster presentation by collaborators at University Hospitals Cleveland Medical Center at the 2023 American Association for Clinical Chemistry (AACC) Annual Scientific Meeting and Clinical Lab Expo that demonstrated the feasibility for quality improvement using SeptiCyte RAPID in patients suspected of sepsis. The poster, entitled "Laboratory Evaluation of the SeptiCyte RAPID Host Response Assay in Differentiating Infection-Positive Versus Infection Negative Systemic Inflammation Patients Suspected of Sepsis," is designated as Poster #A-384 and will be displayed in Session A, Point of Care Testing, on Tuesday, July 25, from 1:30 – 2:30 p.m. PT, in Anaheim, California.
"The early accurate diagnosis of sepsis can be challenging, but recent advancements in FDA-cleared lab tests have introduced new tools that may enhance earlier diagnosis. Collaborative efforts between laboratory professionals and clinicians are essential to evaluate these tests, determine their integration into patient care, and assess their effectiveness," 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 in Cleveland/Case Western Reserve University. "We utilized the SeptiCyte RAPID test in a quality improvement fashion and demonstrated its ease of use for real time sepsis practice. Further large-scale clinical research studies would be beneficial to assess the impact of this test on earlier recognition of sepsis and how this may reflect improved patient management and outcomes."
"With previously shown robust performance, this Quality Improvement feasibility evaluation shows ease of use of the SeptiCyte RAPID test in a large busy clinical setting and laboratory at one of the most respected medical centers in the United States," said Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress. "This further shows that SeptiCyte RAPID can deliver timely and precise results in about one hour from when the lab receives the blood draw. Only a small percentage of sepsis patients have a positive blood culture demonstrating a bacterial infection. SeptiCyte RAPID may aid clinicians in making a confirmatory assessment for patients with sepsis in these cases without a positive blood culture, including patients with sepsis resulting from a viral infection."
The poster focused on some aspects of analytical performance of SeptiCyte RAPID and its correlation with other laboratory findings using blood samples collected from 82 patients admitted to the University Hospitals Cleveland Medical Center who were suspected of suspected sepsis from July to September 2022. SeptiCyte RAPID showed good precision and minimum inter-lab variation, although underpowered and not designed as a research study to evaluate diagnostic and patient outcomes. Nonetheless, preliminary analyses with SeptiCyte RAPID had results that were significantly different between blood culture positive cases (n=22, SeptiScore = 7.2 ± 2.0 [mean ± SD]) and that of pathogen negative non-sepsis (by sepsis retrospective review of event only, n=10) cases (SeptiScore = 5.6 ± 1.6) (p<0.05).
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.
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.
Russo Partners, LLC
Russo Partners, LLC
SOURCE Immunexpress, Inc.