{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,7]],"date-time":"2026-08-07T16:28:52Z","timestamp":1786120132649,"version":"build-2736575974"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"Supplement_1","funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["U01AI148316"],"award-info":[{"award-number":["U01AI148316"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100012399","name":"Biomedical Advanced Research and Development Authority","doi-asserted-by":"publisher","award":["75A50122C0050"],"award-info":[{"award-number":["75A50122C0050"]}],"id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>In 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>We 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\u2019s 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Performance 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/milmed\/usag100","type":"journal-article","created":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T12:41:50Z","timestamp":1772109710000},"page":"362-370","source":"Crossref","is-referenced-by-count":0,"title":["Overcoming Clinical Validation Challenges for an In Vitro Diagnostic Biodosimetry 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