# Validation and early development of a blood-based rapid diagnostic test for sepsis endotypes

> **NIH NIH R44** · INFLAMMATIX, INC. · 2022 · $1,017,950

## Abstract

ABSTRACT
Sepsis, a systemic inflammatory condition, occurs as a complication of infection and in severe cases may be
associated with acute and life-threatening organ dysfunction. In the US alone, sepsis claims ~270,000 lives each
year among ~1.7 million patients diagnosed annually, and globally, sepsis-related mortality is estimated to
account for 20% of total deaths. Although improvements in the treatment protocol for sepsis and timely
administration of antibiotics have reduced mortality rates, not a single drug for sepsis has ever been successfully
brought to market, despite over 100 interventional trials, and it is treated today as 60 years ago: antibiotics and
supportive care. Sepsis is unusual in that a great deal of the immune response is actually adaptive (beneficial)
vs. disease-causing (maladaptive), so reversing the inflammatory response can cause the infection to go
unchecked. We believe that a treatment should reverse the maladaptive (organ-damaging) components of the
immune response, while keeping the adaptive (pathogen-fighting) components intact. We believe that to achieve
impactful progress, new approaches are required that harness immune sub-groups. In this project, we propose
a precision medicine approach to subdivide sepsis patients into treatable subclasses or “endotypes”
using a companion diagnostic test, HostDx-Endotypes. We anticipate that classifying sepsis patients into such
endotypes may allow us to identify improved treatment regimens, leading to the discovery of new targets or
pathways for endotype-specific therapies and/or repurposing of available drugs.
In Phase 1 work we already demonstrated proof-of-concept by identifying 3 sepsis endotypes (Inflammopathic,
Adaptive, and Coagulopathic) and validated across multiple external data sets. We have shown that our HostDx
Endotypes can stratify patients into novel, potentially treatable subgroups across 3 publications using several
retrospective cohorts, and two prospective cohorts. We have also demonstrated the clinical utility of this
paradigm with InSepTM, our robust classifier for acute infectious disease, based on our HostDx point of care test
system platform.
To bridge our proof-of-concept work to product development for HostDx-Endotypes, we will (Aim 1) employ
rigorous machine learning algorithms and processes to finalize and lock an optimal classifier; (Aim 2) apply an
innovative approach of drug repurposing to identify and rank-order endotype-specific drug candidates for clinical
studies on sepsis treatment, and (Aim 3) translate the final mRNA panel to Inflammatix’s qLAMP cartridge and
platform. At Phase II completion we will have produced the HostDx Endotypes research-ready cartridge, together
with a list of repurposed drugs for intended clinical trials, and will be ready to enter the formal product
development phase; we will have initiated the FDA pre-submission. Ultimately, the goal of this product will be to
definitively link a patient sepsis endotype with a ...

## Key facts

- **NIH application ID:** 10462722
- **Project number:** 5R44GM142428-02
- **Recipient organization:** INFLAMMATIX, INC.
- **Principal Investigator:** Timothy E Sweeney
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,017,950
- **Award type:** 5
- **Project period:** 2021-08-15 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10462722

## Citation

> US National Institutes of Health, RePORTER application 10462722, Validation and early development of a blood-based rapid diagnostic test for sepsis endotypes (5R44GM142428-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10462722. Licensed CC0.

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