The HHS Biomedical Advanced Research and Development Authority (BARDA)
is awarding nine contracts for the advanced research and development of
more effective tests and devices to determine the level of radiation a
person has absorbed after a nuclear or radiological incident. The
contracts total $35 million for the initial phase and up to $400 million
over five years.
The contracts are awarded to Arizona State University in Tempe, Ariz.;
Chromologic LLC in Pasadena, Calif.; Duke University in Durham, N.C.;
Meso Scale Diagnostics LLC in Gaithersburg, Md.; Northrop Grumman
Electronic Systems in Linthicum, Md.; SRI International in Menlo Park,
Calif; Stanford University, Stanford, Calif; the University of
Rochester, Rochester, N.Y., and Visca LLC in Troy, Mich.
Each contract awardee has identified particular physical or biological
characteristics, known as biomarkers, to indicate how much radiation a
person has absorbed.
In the first year of the contract, the contractors will conduct studies
to test the accuracy of the biomarkers as an indicator for the level of
absorbed radiation. In addition, they will determine if their proposed
devices measure these biomarkers effectively.
Upon successful completion of these studies, the contractors will
develop prototypes of portable devices that can be used in the field by
responders to test for radiation absorption. Knowing a more precise
measure of radiation exposure will help health care responders determine
the most appropriate treatment for patients exposed to damaging ionizing
radiation, which can destroy the body’s cells.
To develop these devices, contractors will use the U.S. Food and Drug
Administration (FDA) Investigational Device Exemption process. This
process allows the investigational device to be used in a clinical study
in order to collect safety and effectiveness data required to support a
pre-market approval application or a pre-market notification submission
to FDA. If the products are approved by the FDA in future years, the
products may become eligible for consideration and procurement by the
Source HHS Biomedical Advanced Research and Development Authority