# Development of a minimally invasive biomarker assay to detect delayed radiation injury

> **NIH NIH U01** · UNIV OF ARKANSAS FOR MED SCIS · 2021 · $459,161

## Abstract

PROJECT SUMMARY/ABSTRACT
Although the general population continues to be at risk of exposure to ionizing radiation because of nuclear
warfare, terrorism, or radiological accidents, there are currently no biomarker assays that are predictive of
radiation-induced late injury in specific organs. In cases of heterogeneous exposures and for victims who
survive the acute effects, there will be a latent period of months to decades before serious symptoms manifest.
This proposal brings together an inter-disciplinary research team with expertise in radiation biology, animal
models of tissue injury, biomarker development, biostatistics and bioinformatics to identify analytically validated
rapid and minimally invasive assays that predict delayed radiation injury in different organ systems. Discovery
and validation of radiation biomarkers are based on the underlying premises that: 1) a signature of radiation
exposure is present in biofluids (plasma and urine) at some point prior to clinical diagnosis; and 2) early
diagnosis can result in improved clinical care and outcome. Using a discovery-validation study design, we
propose to identify metabolic biomarkers of radiation injury to three major organs at risk for delayed
complications: kidney, heart and brain (Specific Aim 1), and develop a kit-based assay along with a biomarker
scoring algorithm for assessing and predicting injury in these organs (Specific Aim 2). We will make use of our
established rat models of partial and total body irradiation to identify plasma and urine biomarkers that predict
the extent of injury in the kidney, heart and brain before clinical symptoms appear. For this purpose, we will
make use of male and female rats of an inbred and an outbred strain and expose rats to X-rays and a mixed
neutron/γ-ray beam. We will determine which matrix (plasma or urine) provides the best predictor for each of
the organ systems. We will validate rat biomarker panels in independent cohorts of rats and in banked samples
of non-human primates exposed to radiation. Biomarker panels will then be used to develop a prototype
metabolite kit in 96-well format and test its technical feasibility in accordance with good laboratory practice
guidelines. This prototype kit is required for the rapid future development of a field-deployable minimally
invasive biomarker assay that will identify individuals at risk. At the conclusion of these studies, we expect to
delineate minimally invasive, high specificity classification algorithms for predicting delayed radiation injuries in
kidney, heart and brain with >90% specificity, sensitivity, and positive predictive value. While here we focus on
radiation late effects, the standard operating procedures, assay parameters and decision analysis software
developed in this study will serve as a foundation for broader based implementation of minimally invasive
biomarkers in radiation risk assessment.

## Key facts

- **NIH application ID:** 10090564
- **Project number:** 5U01AI148308-02
- **Recipient organization:** UNIV OF ARKANSAS FOR MED SCIS
- **Principal Investigator:** Marjan Boerma
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $459,161
- **Award type:** 5
- **Project period:** 2020-02-01 → 2025-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10090564

## Citation

> US National Institutes of Health, RePORTER application 10090564, Development of a minimally invasive biomarker assay to detect delayed radiation injury (5U01AI148308-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10090564. Licensed CC0.

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