Point-of-care Monitoring of the Host-Pathogen Interaction during Infection

MBio Diagnostics proposes to deliver a point-of-care (POC) technology for monitoring host-pathogen interactions during acute severe infection. The system will deliver a quantitative panel of biomarker immunoassay results using a portable, inexpensive, easy-to-use cartridge and reader. Results will be returned in 30 minutes or less and will require minimal (< 50 µL) blood samples. Initial panels focus on known, clinically relevant host response markers (PCT, CRP, IL-6, IP10), but the device will be readily adaptable to emerging biomarker panels as well. The program has two major tasks. Task 1 will be to develop and deliver a novel 4-plex biomarker cartridge-based assay along with a preliminary clinical sample validation dataset. Task 2 will be to deliver prototype readers that incorporate on-board computer, graphical user interface, and battery functionality. A successful Phase II will deliver an assay cartridge and reader system ready for scale-up and regulatory validations.