# 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 · 2024 · $197,416

## Abstract

The goal of this project is to increase emergency preparedness to respond to a mass casualty
radiological/nuclear incident through the development of a biodosimetry triage device. Under the
parent NIAID U01 award, the ASELL team is developing CellRADx, a point-of-care biodosimetry
triage device that incorporates Complete Blood Count (CBC) with WBC differential, along with
the detection of extracellular and cell-surface biomarkers of radiation exposure. This triage
device will incorporate an exposure assessment algorithm also being advanced under the
parent award, that can utilize inputs from CBC differential measurements from any appropriate
source. To date, iterations of the CellRADx algorithm functionally based on the HARI algorithm
have shown promising performance at dose determination, especially in the later time periods.
Under this Administrative Supplement, ASELL proposes to improve the performance of the
algorithm based on feedback from the FDA and release of a new FDA guidance document on
the credibility of simulated data. The additional tasks proposed herein; therefore, are Algorithm
Performance Improvements, and demonstrating the credibility of our In Silico Acute Radiation
Blood Cell Depletion Model. Areas of algorithm improvement include: 1) use of alternative
algorithm equations, 2) incorporation of time effects into the algorithm, and 3) incorporation of
demographic effects into the algorithm. To address the practical limitations of available human
clinical data, ASELL will pursue use of an in silico hematopoietic cell depletion model to be used
in combination with retrospective real-world human data sources to build a “virtual clinical
cohort” for future clinical studies. ASELL intends to follow the recently released (November
2023) FDA Guidance “Assessing the Credibility of Computational Modeling and Simulation in
Medical Device Submissions.” These tasks will address regulatory inputs and collectively
strengthen development and validation of CellRADx as a qualitative biodosimetry tool for large-
scale radiation triage.

## Key facts

- **NIH application ID:** 11116405
- **Project number:** 3U01AI148316-05S1
- **Recipient organization:** ASELL, LLC
- **Principal Investigator:** Richard Joseph Kowalski
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $197,416
- **Award type:** 3
- **Project period:** 2020-02-01 → 2026-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11116405

## Citation

> US National Institutes of Health, RePORTER application 11116405, 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 (3U01AI148316-05S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11116405. Licensed CC0.

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