A multi-site study confirms the use of undiluted EDTA blood for the SeptiCyte RAPID sepsis assay
SEATTLE and BRISBANE, Australia, Nov. 3, 2022 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the presentation of an abstract at the Association for Molecular Pathology 2022 Annual Meeting in Phoenix. The abstract, entitled, "Multi-site validation of EDTA blood as a sample type for SeptiCyte® RAPID CE-IVD, a near-patient diagnostic test for sepsis on the Biocartis Idylla™ System," will be presented as a poster on Saturday, November 5, 2022 from 9:15 – 10:15 a.m. PDT.
The multi-site study was conducted at University Hospital Bonn in Germany and Hospital Foch in Suresnes, France. It investigated Immunexpress' sepsis diagnostic tool SeptiCyte RAPID CE-IVD in 46 clinically confirmed sepsis and non-sepsis patients. A high degree of correlation (R2 = 0.95) was observed when comparing the SeptiScore® values observed in these patients, processed either from undiluted EDTA blood collection tubes or from a PAXgene® blood RNA tubes. The reproducibility of the EDTA blood result was further assessed by running a subset of the samples in triplicate.
"These data validate the use of undiluted EDTA-anticoagulated blood as an additional sample type for the SeptiCyte® RAPID CE-IVD assay. The ability to process EDTA-anticoagulated blood without further preparation steps makes the assay extremely accessible to all clinical and laboratory settings and work- flows, moreover since only a small blood volume of 240µL whole blood is required," said Dr. Marijo Parcina, investigator and Associate Professor at the Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn.
Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress, added, "These results further expand the clinical utility of our SeptiCyte® RAPID assay. Because hematology testing is generally performed on EDTA blood, this sample type is universally collected in hospital settings, is often the first to be drawn, and thus enables the quantification of a sepsis probability in suspected patients at the moment potentially life-saving clinical decisions must be made."
SeptiCyte® RAPID EDTA blood compatible cartridges may be purchased in Europe via our distribution partner Biocartis. Immunexpress expects SeptiCyte® RAPID EDTA cartridges will be available in the United States by June 2023.
About SeptiCyte® RAPID
SeptiCyte® RAPID is a sample-to-answer, cartridge-based, molecular test for sepsis using reverse transcription polymerase chain reaction (PCR) which quantifies 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 in patients suspected of sepsis. SeptiCyte® RAPID generates a score (SeptiScore®) that falls within four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte® RAPID is intended for in-vitro diagnostic use and is used on the Biocartis Idylla™ System.
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 out of 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 to guide the physician in optimizing patient management decisions. SeptiCyte® RAPID is a lab test for sepsis that combines SeptiCyte® technology with the Biocartis' Idylla™ platform*, empowering clinicians to swiftly differentiate infection positive (sepsis) from infection negative systemic inflammation in patients suspected of sepsis; diagnosing bacterial sepsis, viral sepsis, or fungal infections. This powerful combination of technologies enhances certainty for early sepsis diagnosis, to improve clinical outcomes and lower healthcare costs.
In March 2020, Immunexpress received CE Marking of SeptiCyte® RAPID and announced a commercialization partnership with Biocartis in Europe. In November 2021, Immunexpress received FDA clearance for SeptiCyte® RAPID.
For more information, visit http://www.septicyte.com and http://www.immunexpress.com/. Follow Immunexpress on Twitter and LinkedIn.
Media Contact:
Maddie Stabinski
Russo Partners, LLC
Madeline.stabinski@russopartnersllc.com
SOURCE Immunexpress, Inc.
