# PredictSEP: A Predictive Diagnostic Assay for Sepsis

> **NIH NIH R43** · CFD RESEARCH CORPORATION · 2022 · $342,689

## Abstract

Abstract
Sepsis is the leading cause of death in hospitals caused by a dysregulated host immune response
to infection characterized by excessive neutrophil infiltration into vital organs, organ failure and
death. Although blood tests relying on identification of pathogens are widely utilized to decide on
treatment, they are severely limited by their ability to rapidly predict the onset, progression and
recovery from sepsis.
Hence, the goal of this proposal is to design, develop and demonstrate a rapid predictive assay
using the native dysfunctional environment of the neutrophil observed in sepsis. This
microfluidics-based assay provides quantitation of the neutrophil behavior for a predictive score
reflective of the prognosis of the patient. Phase I will focus on validating our assay within 60
minutes with a sample population comprised of sepsis patients, SIRS patients, and healthy
controls. Phase II will focus on building an instrumentation for the complete assay along with large
patient study and plans for FDA approval.

## Key facts

- **NIH application ID:** 10484762
- **Project number:** 1R43GM146559-01
- **Recipient organization:** CFD RESEARCH CORPORATION
- **Principal Investigator:** Ketan H Bhatt
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $342,689
- **Award type:** 1
- **Project period:** 2022-07-18 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10484762

## Citation

> US National Institutes of Health, RePORTER application 10484762, PredictSEP: A Predictive Diagnostic Assay for Sepsis (1R43GM146559-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10484762. Licensed CC0.

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