Novel Approaches for Radiation Biodosimetry Assays and Devices Development (U01 Clinical Trial Not Allowed)

The purpose of this notice of funding opportunity (NOFO) is to support radiation research at all stages of development for the identification of biomarkers of injury and the development of assays or devices for the purpose of triage, including assessing absorbed dose or predicting health outcomes of acute or delayed injuries resulting from radiation exposure during a public health emergency. This NOFO will support the development of these approaches, with the goal of future regulatory approval. The focus of this NOFO is the development and validation of rapid, reliable, inexpensive, and easy-to-use techniques/assays and devices for use in all segments of the civilian population including geriatric, pediatric, and immune-compromised individuals. Thus, research activities ranging from immediate, early, and delayed changes in radiation-related biomarkers, studies exploring the biokinetics of the proposed biomarker signature, and studies to predict the acute or chronic health outcome in one or more organs are requested. The selection of radiation exposure type, dose level, and dose rates proposed for studies should be relevant to a radiological or nuclear incident and verified by appropriate dosimetry assessments. The ideal radiation signature will be measurable in a non-invasive or minimally invasive way (e.g., finger stick, urine, saliva, or skin scraping as opposed to spinal fluid or complex imaging) that will allow for repeated assays over time, is sensitive to incremental differences in radiation exposure, is specific over a wide range of radiation doses and dose rates and has utility for different qualities of radiation (high and low linear energy transfer).