The Biomedical Advanced Research and Development Authority (BARDA) is seeking capability statements from businesses to provide verification, validation, regulatory approval, manufacturing and acquisition services for high throughput biodosimetry devices.
The Radiation Biodosimetry High Throughput (HT) Test is intended to be run in clinical laboratories and produce a quantitative estimate of the actual absorbed radation dose a person received from 0 to 10 Gy. The result will be used in conjunction with signs, symptoms, and hematology to give the health care provider additional information to help in treating individuals after a radiological or nuclear incident.
The typical symptoms of radiation exposure in humans (dose range of 0.5 to 10 Gy) include nausea, vomiting, diarrhea, and peripheral blood lymphocyte depletion. The duration of initial or prodromal symptoms and the latent phase of radiation syndrome is anywhere from 1 hours to 2 weeks.
Without appropriate medical care, the median lethal dose of radiation, the LD50/60 (the dose that kills 50% of the exposed population within 60 days after exposure), is estimated to be 4.5 Gy. However, the likelihood of survival can be significantly increased with appropriate aggressive medical intervention and care.
For this effort, systems must be mature enough to enter into verification and validation activities consistent with FDA guidelines within the next year, with a minimum Technology Readiness Level of 6 at proposal submission.
Respondents must provide evidence that they have or have plans to achieve specified GMP instrument manufacturing capabilities, if the instrument being used for the assay is not currently commercially available.
Further details are available via Solicitation Number: CBRN-BAA-15-100-SOL-00010. The response deadline is Dec 15, 2014.