FOR IMMEDIATE RELEASE
December 18, 2009
Contact: Gretchen Michael
BARDA Awards Contracts for Tests and Devices to Help the Nation Respond to a Radiological Emergency
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 U.S. government.
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BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides a comprehensive integrated portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing infrastructure building of the necessary vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health medical emergencies including chemical, biological, radiological, and nuclear threats, and pandemic influenza, and emerging infectious diseases. For additional information, visit www.hhs.gov/aspr.
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Last revised: May 7, 2011