BARDA and Immunexpress Inc. expand partnership to evaluate a sepsis host-based laboratory diagnostic to triage COVID-19 patients
BARDA and Immunexpress Inc. are collaborating to determine the risk of sepsis in COVID-19 patients in the hospital emergency department or ICU. These studies will be used to support 510(k) Food and Drug Administration filing of the SeptiCyte® RAPID diagnostic test for sepsis, including virally induced sepsis caused by the SARS-CoV-2 virus. Immunexpress will evaluate its CE-marked Septicyte®RAPID assay as a sepsis triage tool for patients who show escalating signs of COVID-19 disease.
In light of the current COVID-19 pandemic and a surge of critically ill patients being admitted to hospitals, healthcare providers need technologies that can assist with rapid early identification of patients likely to progress to severe disease that need clinical intervention. Immunexpress has developed SeptiCyte® RAPID, a host-based gene expression assay to rapidly assess patients suspected of infection for their likelihood to progress to sepsis. SeptiCyte® RAPID will be validated for its ability to effectively triage COVID-19 patients for risk of viral sepsis.
The SeptiCyte® host response assay uses a novel gene signature for rapid assessment of a patient’s immune response to infection. The test uses an automated cartridge format on the Biocartis IdyllaTM molecular diagnostic platform and provides results in less than 90 minutes. The overall solution is expected to allow clinicians to detect patients at risk of increased disease severity in COVID-19 to facilitate appropriate resource allocation and early treatment for those with higher risk. This study is part of BARDA’s Rapidly Deployable Capabilities program to identify and pilot near-term innovative solutions for COVID-19.
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
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Immunexpress is a molecular diagnostic company 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.