Multiplexed Multi-omics Biomarker Panel From Minimally Invasive Biomatrix

Multi-omics technologies are increasingly pivotal for diagnosing complex diseases such as PTSD, traumatic brain injury, cancer, and organ damage. Despite rapid research progress in utilizing multi-omics for evaluating and diagnosing these diseases, dedicated point-of-care platforms to support these findings are yet to be developed. Consequently, there is a pressing need for sample-to-answer platforms capable of processing minimally invasive sample types and delivering metabolomic, proteomic, transcriptomic, and genomic data in a clinical setting. This Phase II project aims to develop a rapid, sensitive, low-cost, easy-to-use, and portable multi-omic platform for point-of-care diagnostics. The proposed novel in vitro diagnostic platform comprises a consumable fluidic cartridge designed to process whole blood into plasma, coupled with an electrochemical sensor array for comprehensive multi-omic analysis. Building upon the Phase I proof-of-concept, which demonstrated successful whole blood sample preparation and quantification of key metabolites, proteins, miRNAs, and methylated DNA, our Phase II efforts will focus on integrating sample-to-answer components that enable direct multi-omic readouts from whole blood. A critical aspect of our work involves benchmarking our multi-omic platform against gold standard analysis techniques. Successful completion of Phase II objectives will yield an advanced prototype of the first multi-omic point-of-care in vitro diagnostic (IVD) device. Subsequent Phase III efforts will concentrate on prototype manufacturing and progressing toward FDA approval, ultimately paving the way for transformative clinical applications of this technology.