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.
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.
The base contract is expected to be awarded in late FY 2015 or early FY 2016. Options for manufacturing and an initial resupply of tests, reagents and other items that outdate are expected to be excised following approval of the Radiation Biodosimetry HT Test by the FDA and at the discretion of the government.
Further details are available via Solicitation Number: CBRN-BAA-15-100-SOL-00010. Responses are due Dec 15, 2014.