NEW YORK ─ Molecular diagnostics firm Immunexpress said Tuesday that it has been awarded a grant of up to $599,549 by the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) to develop its host response sepsis test, SeptiCyte Rapid, as a triage tool to help identify SARS-CoV-2 patients with an elevated risk for viral or secondary bacterial sepsis.
SeptiCyte Rapid is a gene expression assay that uses reverse-transcription PCR to quantify the relative expression levels of host response genes isolated from whole blood.
With the BARDA funding, Seattle-based Immunexpress expects to validate its test as a triage tool and pursue US Food and Drug Administration Emergency Use Authorization.
"The COVID-19 pandemic has exacerbated the need for rapid identification and triage of COVID-19 patients at risk of sepsis," Rolland Carlson, CEO of Immunexpress, said in a statement. "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."
Immunexpress received the CE-IVD mark for SeptiCyte Rapid in March and announced a long-term commercialization partnership with Mechelen, Belgium-based Biocartis in Europe. The diagnostic test runs on the Biocartis Idylla system.