Seattle, WA /PRNewswire/ - Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today the launch of new SeptiCyte RAPID® EDTA blood compatible cartridges for the European market. The updated SeptiCyte® RAPID CE-IVD cartridge adds undiluted EDTA blood as a validated sample type, representing a significant development milestone for this proprietary, first to market host response technology. EDTA blood collection tubes are used routinely in clinical settings for hematology procedures around the world. A multi-site European validation study conducted by Immunexpress achieved high correlation (R2 > 0.9) between whole blood samples from suspected sepsis patients collected in PAXgene® blood RNA or EDTA blood collection tubes across the full SeptiScore® range. Validation of the updated SeptiCyte® RAPID cartridge for the US market is underway with FDA 510(k) studies expected to complete in Q4 2022.
Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress, commented: "The addition of undiluted EDTA blood as a validated sample type for SeptiCyte RAPID CE-IVD addresses a meaningful hurdle, accelerating the clinical adoption for clinical laboratories worldwide. We are excited to launch the new SeptiCyte RAPID® EDTA blood compatible cartridges and anticipate broader and faster adoption of our SeptiCyte® RAPID test, which we believe is poised to transform patient care, lower associated medical costs, and decrease the burden on the healthcare system."
SeptiCyte® RAPID EDTA blood compatible cartridges will be sold in Europe via our distribution partner Biocartis.
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.
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.
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