Immunexpress Awarded BARDA Contract to Develop SeptiCyte® RAPID for COVID-19 Patient Triage
SEATTLE, June 16, 2020 /PRNewswire/ -- Immunexpress, Inc., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, has been awarded a grant from the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), of up to $599,549 to develop and pursue U.S. Food and Drug Administration Emergency Use Authorization (EUA) for the host response sepsis test SeptiCyte® RAPID which has the potential to assess and triage patients with escalating signs of COVID-19 disease. With the funding from BARDA, Immunexpress expects to complete development work necessary to validate its role as a triage tool to help identify COVID-19 patients with an elevated risk for viral or secondary bacterial sepsis.
The ongoing COVID-19 pandemic underscores the unmet need for technologies that efficiently discriminate patients with mild infection from those that have an elevated risk for serious complications, including viral or secondary bacterial 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 SeptiCyte® 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 and appropriately assign limited resources.
"The COVID-19 pandemic has exacerbated the need for rapid identification and triage of COVID-19 patients at risk of sepsis," stated Rolland D. Carlson, Ph.D., Chief Executive Officer of Immunexpress. "Equipping clinicians with the best tools to manage patients quickly, safely and appropriately is the first step in addressing the high mortality rate associated with sepsis infection in COVID-19 patients."
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.
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).
Immunexpress is a molecular diagnostic company, founded in Australia and based out of Seattle, Washington, USA, committed to improving outcomes for patients suspected of sepsis. Immunexpress' SeptiCyte® technology can assess a patient's immune response by quantifying and analyzing gene expression signatures from whole blood, providing actionable results in about an hour to guide the physician in optimizing patient management decisions. SeptiCyte® RAPID 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. 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 long-term commercialization partnership with Biocartis in Europe.
*Immunexpress is licensed to use the Idylla™ trademark from Biocartis NV.
Russo Partners, LLC
1 Zhou, 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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SOURCE Immunexpress, Inc.