# Research and Development of a Hand-held, Rapid, Point-of-Care Radiation Biodosimetry Triage Device and Integration of Soluble and Cell-surface Radiation Injury Biomarker Assays

> **NIH NIH U01** · ASELL, LLC · 2022 · $101,546

## Abstract

NIH-NIAID RFA-A1-18-045
Project Summary/Abstract
The overall goal of this project is to advance our nation's ability to protect public health in the
event of a large-scale, radiation/nuclear event by developing a single mobile point of care (POC)
diagnostic device that will fill three identified gaps in our country's current radiation triage
assessment capabilities. First, it will distinguish the worried-well from individuals exposed to
radiation doses at a threshold of 2Gy; second, it will provide an assessment of hematopoietic
acute radiation syndrome (H-ARS) severity risk, as well as a radiation dose estimate beyond
2Gy; and third, it will allow the detection and quantification of soluble (Specific Aim 1, SA1) and
cell-surface associated (Specific Aim 2, SA2) blood- and organ-specific radiation damage
biomarkers to provide critical information about major organ and physiological system
damage/failure. The thrust of this proposal will be on developing and demonstrating the ability to
detect radiation damage biomarkers on an innovative handheld device. The device is comprised
of a well-vetted POC blood cell analyzer capable of performing a 5-part leukocyte differential
analysis in field-settings using an innovative lensless microscopy technology. The device
utilizes a fingerstick of whole blood and provides results in under 8 minutes. Here, we will
further expand these capabilities to allow for the immunoassay-based analysis of blood/plasma
radiation damage biomarkers. We initially will demonstrate the ability to detect and quantify
three soluble biomarkers of radiation damage in human blood samples; serum amyloid-A,
salivary α-amylase, and Fms-related tyrosine kinase 3 ligand, representing markers of
inflammation, salivary gland damage, and bone marrow progenitor cell distribution, respectively;
thereby demonstrating the utility of the system for multiple systems damage assessment. Our
immunoassay for soluble biomarkers will use a highly sensitive microsphere-complex formation
format that also allows for multiplex capabilities. In addition, we will demonstrate the ability to
detect a number of cell surface specific radiation damage biomarkers on our device. Lastly, we
will integrate into the device two biodosimetry-specific algorithms to allow the conversion of
blood cell enumeration data into indicators of radiation injury, dose exposure, and a prediction of
the risk of development of H-ARS (Specific Aim 3, SA3). By providing a single portable
diagnostic device capable of addressing many of the gaps that have been identified by NIAID in
our country's ability to respond to severe radiation incidents we will significantly advance
radiation triage public health responsiveness, as well as provide for the potential to revolutionize
POC immunodiagnostics.

## Key facts

- **NIH application ID:** 10596303
- **Project number:** 3U01AI148316-03S1
- **Recipient organization:** ASELL, LLC
- **Principal Investigator:** Richard Joseph Kowalski
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $101,546
- **Award type:** 3
- **Project period:** 2020-02-01 → 2025-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10596303

## Citation

> US National Institutes of Health, RePORTER application 10596303, Research and Development of a Hand-held, Rapid, Point-of-Care Radiation Biodosimetry Triage Device and Integration of Soluble and Cell-surface Radiation Injury Biomarker Assays (3U01AI148316-03S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10596303. Licensed CC0.

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