ArticleMilitary medicine2026
Overcoming Clinical Validation Challenges for an In Vitro Diagnostic Biodosimetry Test.
Article in Military medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
Funding
Abstract
introductionIn the aftermath of a nuclear detonation or other mass-casualty radiological event, thousands to millions of people may be exposed to high levels of radiation. Effective triage tools are needed to identify those with potentially life-threatening exposure requiring emergency medical care. To ensure these tools will be available to support a mass-casualty radiation event, US Food and Drug Administration (FDA) authorization is required. However, currently, no FDA-authorized biodosimetry tests are available to support a mass-casualty radiological event, due largely to the significant challenges in developing regulatory strategies for biodosimetry tests. MATERIALS AND
methodsWe have developed a tool, called the CellRADx Software Application, to help address this mass-casualty triage need. CellRADx utilizes complete blood count (CBC) results from a single test, along with other inputs such as age and time post-exposure, to determine if an individual has absorbed more than 2 Gy of ionizing radiation. As part of the development of CellRADx, we have created a novel approach to facilitate the complete validation of the software device in compliance with FDA's medical device regulations. This novel approach employs a combination of real-world CBC data, an in silico radiation-induced cell depletion model, and nuclear event dose distribution models to validate clinical performance.
resultsPerformance of CellRADx across the general population has been demonstrated with high sensitivity (92%) and high specificity (78%). Additional subpopulations with potentially confounding conditions were also tested using this approach and have demonstrated similar performance results.
conclusionThe ability to validate a biodosimetry device using a method that can support FDA authorization is a key enabling development that will facilitate implementation of tools that can improve preparedness for a mass-casualty nuclear event and help save many lives.
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