Using biodosimetry to enhance the public health response to a nuclear incident

Abstract

Radiation Biodosimetry is a continually developing clinical diagnostic field, which focuses on biological markers that proportionally change in relationship to the amount of ionizing radiation absorbed. Examples of host marker response include changes in white cell count, specific proteins in circulation, RNAs in white blood cells, or chromosome fidelity in affected lymphocytes. Measurements of radiation biomarkers correlate with the approximate radiation dose absorbed and indirectly provide an assessment of the likelihood of developing acute radiation syndrome. The aim of this review is to summarize four biodosimetry programs that are in advanced development, later pipeline stages with funding from the Biomedical Advanced Research and Development Authority (BARDA), an agency under the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS). With BARDA financial support, biodosimetry diagnostic assays in development will inform patient management, improve health and psychosocial outcomes, and save lives after a nuclear disaster. These tests include an SRI International developed rapid on-site screening test requiring only a finger stick of blood to triage those who have received little or no radiation from those who have received clinically significant levels of radiation and need further immediate patient management. In addition, multiple laboratory-based, high-throughput quantitative tests, currently under development by MRIGlobal, DxTerity, and ASELL, will more accurately define dose levels and possibly predict cellular and organ-damage and other longer-term effects of radiation. In the future, when clinical and analytical validation of these assays is complete, the data is reviewed by the FDA, and agency use status is obtained, rapid triage and laboratory-based biodosimetry test results will enable emergency medical teams to do the most good for the largest number of people after a nuclear blast.

Keywords:

• Biodosimetry
• nuclear detonation
• biomarkers
• proteomics
• gene expression

Disclosure statement

The authors have no conflicts of interest. The authors alone are responsible for the content and writing of the paper.

Additional information

Funding

The United States Department of Health and Human Service, Office of the Assistant Secretary of Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), Washington, DC supported the work.

Notes on contributors

L. K. Wathen

Paul S. Eder, Ph.D., is a Principal with Tunnell Government Services, a contractor that supports the Biomedical Advanced Research and Development Authority (BARDA) in the U.S. Department of Health and Human Services. As a biochemist, he advises the Detection, Diagnostics, and Devices Infrastructure (DDDI) Division within BARDA on in vitro diagnostics product development, and in particular has advised on biodosmietry assay development for the last seven years.

P. S. Eder

Gary Horwith, MD is a contractor with Tunnell Government Services, a company that supports the Biomedical Advanced Research and Development Authority (BARDA) in the U.S. Department of Health and Human Services. As an infectious diseases physician, he has been involved in the clinical development of vaccines, drugs, and devices for over thirty years, and is currently a senior subject matter expert in clinical development and pharmacovigilance.

G. Horwith

Lynne K. Wathen, Ph.D, is a contractor with Tunnell Government Services, supporting BARDA. As a radiation biologist and former biodosimetry team leader, she coaches medical countermeasure diagnostic development for medical and public health preparedness. She has over thirty years of experience developing therapeutics, vaccines, and diagnostics to change health outcomes.

R. L. Wallace

Rodney L. Wallace is Director of Detection, Diagnostic, & Devices Infrastructure Division (DDDI), Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), US Department of Health and Human Services (HHS). The DDDI division funds development of diagnostic systems and medical devices for use in treatment of casualties from pandemic Influenza, radiation/nuclear threats, biological agent threats, and chemical agent threats.