Immunexpress, Debiopharm, and Biocartis entered a worldwide, exclusive, royalty-bearing license for SeptiCyte® Triage for sepsis diagnosis and prognosis. As part of the agreement Debiopharm will complete an equity investment in Immunexpress of A$2 million. The deal covers late-stage development and commercialization of this multiplex gene-expression assay for use in emergency and intensive care units (ICUs) or upon hospital admission to identify sepsis early, differentiate sepsis from other forms of inflammation, and determine sepsis severity.
Under the arrangement Debiopharm will fund the validation and FDA clearance of SeptiCyte Triage. Biocartis will subsequently fund the development and commercialization of the validated assay on its fully integrated molecular diagnostics platform. This platform, which includes an instrument, communication console, and single-use cartridges, can detect and quantify multiple DNA- or RNA-based biomarkers in a variety of patient sample types with minimal user intervention in less than 90 minutes, according to Biocartis.
“With accuracy significantly better than procalcitonin, bringing SeptiCyte Triage onto Biocartis’ revolutionary point-of-need multiplex qRT-PCR platform will enable clinicians to more quickly and accurately identify and triage patients suspected of sepsis,” notes Roslyn Brandon, president and CEO, Immunexpress.
The Immunexpress SeptiCyte technology quantifies specific and multiple molecular markers from the patient’s own immune system for earlier detection, severity assessment, and better timing and targeting of drug and other therapies. Results from Immunexpress clinical trials show that biomarkers of the patient’s immune response are more accurate and instructive than pathogen detection for early detection and improved management of sepsis. By translating and quantifying complex molecular signals in an objective score, SeptiCyte provides reports on disease probabilities.
Besides SeptiCyte Triage the SeptiCyte technology is the basis for SeptiCyte STAT and SeptiCyte RTT. Both are intended for use on the Biocartis platform in a variety of critical care hospital settings but will also be available for other standard hospital laboratory platforms.