Clinical Validation of a Point-of-Care Precision Medicine Endotyping Platform

Principal Investigator/Program Director (Last, first, middle): Reddy, Jr., Bobby Project Summary: Sepsis is a devastating and highly heterogeneous diseases that each encompass a wide range of etiologies, sites of infections, and a wide spectrum of pathophysiologic and biologic manifestations. This heterogeneity is a critical problem for the development of novel therapeutics. Prenosis has pioneered a biomarker-based, machine learning approach to endotype classification for characterizing host response to infection and deconvoluting disease heterogeneity. Endotypes are subgroups of patients with similar biologic processes or states, and the fields of sepsis and ARDS have identified biological endotyping as the leading approach to overcome the challenges heterogeneity poses to patient care and therapeutic development in acute care. The Prenosis host response maps and endotypes are built on the proprietary NOSIS dataset/biobank, which links clinical data to 91,000+ biospecimens from over 23,000 infection patients at 10 U.S. hospital sites. Patient plasma samples are assayed for 43 protein biomarkers and combined with clinical measurements (labs, vitals, etc.) extracted from patient EMRs using sophisticated AI to construct precision medicine maps that summarize patient pathophysiology at a particular moment in time. The Immunix platform brings together clinical data, novel host response biomarkers, and AI-enabled precision medicine tools in real time at the point of care. This combination is tremendously innovative. This is the approach that researchers and Key Opinion Leaders in sepsis and ARDS have been clamoring for and working toward. It is unquestionably an important step forward for the field, and it is no exaggeration to claim it has the potential to change the way clinical trials are run in acute care. Every component of this platform is complete and validated. This project is the final step in demonstrating the capabilities of the entire Immunix platform. The overall hypothesis of the current project is that the Prenosis Immunix platform, which includes the ImmunoScan Multiplex Rapid Test, can deploy precision medicine patient stratification solutions to the point of care in real time. The overall goal is to leverage the NOSIS biobank, Prenosis’ existing biomarker testing pipeline, and our network of hospital sites to validate ImmunoScan immunoassays and generate mapping functions to Luminex Immunoassays (Aim 1); validate a parsimonious model for point-of-care endotyping (Aim 2); and demonstrate in a prospective study the ability of Immunix to classify patients into host response endotypes in real time at the point of care (Aim 3). Successful completion of this project will show that the Immunix platform is fully capable of patient stratification and set the stage for running precision medicine clinical trials in acute care, a prospect whose innovation and significance cannot be overstated.