# Combined Biomarker and EMR Data for Heterogeneous Treatment Effects and Surrogate Endpoints in Sepsis

> **NIH NIH R44** · PRENOSIS, INC. · 2024 · $1,161,624

## Abstract

Principal Investigator/Program Director (Last, first, middle): Reddy, Jr., Bobby
Project Summary:
Sepsis is a poorly understood clinical syndrome characterized by dysregulated host response to infection. The
complexity and heterogeneity of the host response has frustrated attempts at developing effective treatments.
In partnership with 6 U.S. hospitals, Prenosis amassed NOSIS, one of the world’s largest datasets and biobanks
that combines biomarker and clinical data for patients suspected of infection, housing over 60,000 plasma or
serum samples from over 12,000 patients. We also curated a dataset of dense time-series data from each
patient’s Electronic Medical Record (EMR), including demographics, vitals, lab results, interventions, outcomes,
and many other parameters.
In this project, Prenosis will build upon previous work to conduct targeted analyses of the individual treatment
effects of corticosteroids on septic patient outcomes. Using propensity score matching on patient baseline data
(their biomarker/EMR profile at the time they were suspected of serious infection), we have identified 1,350 pairs
of treatment and control patients whose samples have already been collected and stored in the biobank. We will
leverage our existing pipeline to measure the 40 core biomarkers on 8,100 samples for these 2,700 patients: the
pre-treatment sample closest to the time at which the treatment patient received steroids, the sample closest to
24 hours after the treatment patient received steroids, and the patients’ final samples to understand how
treatment impacted biomarker profile and how these changes are associated with clinical outcomes of interest.
These data and analyses will serve as the basis for at least three immediately commercializable products. First,
elucidating which patients are likely to benefit or suffer from treatment with corticosteroids will improve diagnostic
and clinical decision support products that are deployable within Prenosis’ existing ImmunixTM platform. Second,
this will demonstrate the NOSIS dataset is a powerful platform for predictive enrichment of clinical trials.
Estimating individual treatment effects in NOSIS identifies the optimal patient subpopulations to be recruited for
clinical trials, which would otherwise fail. Third, understanding treatment effects on biomarker profile and
corresponding association with clinical outcomes will establish the NOSIS host response profile as effective
surrogate endpoints for clinical trials.

## Key facts

- **NIH application ID:** 10845463
- **Project number:** 5R44GM149065-02
- **Recipient organization:** PRENOSIS, INC.
- **Principal Investigator:** Bobby Reddy
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,161,624
- **Award type:** 5
- **Project period:** 2023-06-01 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10845463

## Citation

> US National Institutes of Health, RePORTER application 10845463, Combined Biomarker and EMR Data for Heterogeneous Treatment Effects and Surrogate Endpoints in Sepsis (5R44GM149065-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10845463. Licensed CC0.

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