The NIAID/RNCP Biodosimetry Program: An Overview

Abstract

Established in 2004, the Radiation and Nuclear Countermeasures Program (RNCP), within the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health has the central mission to advance medical countermeasure mitigators/therapeutics, and biomarkers and technologies to assess, triage, and inform medical management of patients experiencing acute radiation syndrome and/or the delayed effects of acute radiation exposure. The RNCP biodosimetry mission space encompasses: (1) basic research to elucidate novel approaches for rapid and accurate assessment of radiation exposure, (2) studies to support advanced development for US Food and Drug Administration (FDA) clearance of promising triage or treatment devices/approaches, (3) characterization of biomarkers and/or assays to determine degree of tissue or organ dose that can predict outcome of radiation injuries (i.e., organ failure, morbidity, and/or mortality), and (4) outreach efforts to facilitate interactions with researchers developing cutting edge biodosimetry approaches. Thus far, no biodosimetry device has been FDA cleared for use during a radiological/nuclear incident. At NIAID, advancement of radiation biomarkers and biodosimetry approaches is facilitated by a variety of funding mechanisms (grants, contracts, cooperative and interagency agreements, and Small Business Innovation Research awards), with the objective of advancing devices and assays toward clearance, as outlined in the FDA's Radiation Biodosimetry Medical Countermeasure Devices Guidance. The ultimate goal of the RNCP biodosimetry program is to develop and establish accurate and reliable biodosimetry tools that will improve radiation preparedness and ultimately save lives during a radiological or nuclear incident.

Keywords: Biodosimetry assays; Definitive dose; Mechanisms; Predictive biodosimetry; Resources; Triage.

Fig. 1.

RNCP outreach and engagement pipeline.

Fig. 2.

RNCP engagement and Biodosimetry portfolio from 2004 to present.

Fig. 3.

RNCP funding mechanisms to support biodosimetry advancement along the entire research continuum.

Fig. 4.

RNCP grants funded by the NIAID Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Program.

Fig. 5.

Representative dosimetry maps demonstrating effect on dose distribution from energy output, fluence, and filtration. a and b are images of dose distribution maps from the same cabinet style X-ray irradiator delivering a 4 Gy dose under two different energy output settings and with two different amounts of beam filtration, while c and d are dosimetry maps from a second cabinet style X-ray unit delivering the same dose but under different energy and beam conditions.