Immunexpress Receives CE Mark and Signs European Commercialization Partnership for SeptiCyte® RAPID
SeptiCyte® RAPID can swiftly differentiate infection positive (sepsis) from infection negative systemic inflammation in patients suspected of sepsis
Commercialization of SeptiCyte® to triage COVID-19 patients will be the focus of Biocartis partnership in Europe
SEATTLE and BRISBANE, Australia, March 26, 2020 /PRNewswire/ -- Immunexpress, Inc. a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced it has received CE Marking of SeptiCyte® RAPID for its host response technology. SeptiCyte® RAPID combines SeptiCyte® technology with the Biocartis Idylla™ platform, providing actionable results in about one hour to guide the physician to optimize patient management decisions.
The CE Marking of SeptiCyte® RAPID is a significant accomplishment for Immunexpress, enabling the company to market and sell the near-patient sample-to-answer test in European Union (EU) member countries and those harmonized with the EU IVD Directive (98/79/EC). Immunexpress plans to immediately initiate commercial operations in Europe, and announced a long-term commercialization partnership with Biocartis NV, an industry leader in the molecular diagnostic space. Biocartis currently has over 1,300 Idylla™ instruments installed throughout the world.
"Achieving the CE IVD registration and entering commercialization of Immunexpress' leading host response SeptiCyte technology represents a new and exciting phase for our company," said Rolland Carlson, Ph.D., Chief Executive Officer of Immunexpress. "We believe Biocartis, with its well established and growing customer base, will be highly effective in delivering to the European community a new and novel sepsis diagnostic tool, designed to enhance the certainty of early and rapid sepsis diagnosis, to improve clinical outcomes and to lower healthcare costs."
The ongoing COVID-19 pandemic underscores the unmet need for technologies that efficiently discriminate patients with mild infection from those that may develop serious complications related to sepsis, especially when critical medical resources are in short supply. In a recent study of the risk factors associated with COVID-19 mortality, sepsis was the most frequently observed complication1. The early diagnosis of bacterial and viral sepsis with SeptiCye® RAPID, including the immediate and overwhelming global need to triage COVID-19 patients with worsening prognoses, will ensure rapid initiation of sepsis management protocols increasing the potential to save lives.
Dr. Carlson continued, "Together with Biocartis, Immunexpress is committed to mitigating the constraints on hospitals that are affected by the COVID-19 pandemic. We are urgently working towards improving patient outcomes by swiftly triaging COVID-19 patients to receive the most appropriate treatment. Accurate diagnostic testing of sepsis is more important now than ever to enable physicians to make rapid clinical decisions in resource-constrained ICUs."
About SeptiCyte® RAPID
SeptiCyte® RAPID is a gene expression assay using reverse transcription polymerase chain reaction (PCR) to quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene® Blood RNA Tube. 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 one of three 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.
*Immunexpress is licensed to use the Idylla™ trademark from Biocartis NV.
1Zhou, F., et al. (2020) Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. The Lancet. DOI: https://doi.org/10.1016/S0140-6736(20)30566-3
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