NEW YORK (GenomeWeb) — Immunexpress said today that it has received a funding commitment of $744,739 from the US Department of Health and Human Services (HHS) for the development and commercialization of its SeptiCyte sample-to-result sepsis assay.
The RT-qPCR assay, which received US Food and Drug Administration 510(k) clearance in early 2017, is designed to rapidly differentiate infection-positive systemic inflammation — or sepsis — from infection-negative systemic inflammation — or systemic inflammatory response syndrome. About a year ago, Seattle-based Immunexpress signed an agreement to adapt SeptiCyte for use on Biocartis' Idylla platform, with an eye toward getting the test into point-of-care settings.
According to Immunexpress, HHS's Biomedical Advanced Research and Development Authority (BARDA) will provide the new funding through its Division of Research, Innovation, and Ventures (DRIVe) to help offset the estimated $3.2 million it will take to finalize and launch SeptiCyte. Immunexpress will be responsible for the remaining development costs, BARDA said.
"The support provided to Immunexpress by BARDA through DRIVe further validates the potential of our SeptiCyte technology and enables an accelerated development pathway for the product," Immunexpress CEO Rolland Carlson said in a statement. "With this support, we can provide our SeptiCyte technology, translated on the Biocartis Idylla platform, to ICUs and military field-hospitals around the world."