Contracts to Develop Field Tests for Radiation Exposures
The nine contracts worth up to $400 million have been awarded by the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority and can lead to prototype devices for responders.
Nine contracts worth up to $400 million have been awarded by the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop more effective tests and devices to measure how much radiation people absorb after a nuclear or radiological incident. The contracts' first phase will be worth $35 million; the $400 million covers five years.
Receiving contracts were Arizona State University in Tempe; 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; the University of Rochester in Rochester, N.Y., and Visca LLC in Troy, Mich.
HHS' Dec. 18 announcement said each organization has identified particular physical or biological characteristics, known as biomarkers, and will conduct studies to test the accuracy of those biomarkers as an indicator for the level of absorbed radiation and to determine whether their proposed devices measure the biomarkers effectively. If the studies show promise, the contractors will develop prototypes of portable test devices for responders to use in the field.
HHS said the contractors will use the U.S. Food and Drug Administration Investigational Device Exemption process, which allows an investigational device to be used in a clinical study to collect safety and effectiveness data required to support a pre-market approval application or pre-market notification submission to FDA.
The Pandemic and All Hazards Preparedness Act, enacted in December 2006, created BARDA within HHS and made it the hub of federal efforts to develop and acquire medical countermeasures to protect the U.S. civilian population against CBRN and naturally occurring threats to public health. Earlier this month, HHS and the American Medical Association co-hosted the 2009 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) stakeholders workshop/2009 BARDA industry day in Washington, D.C. Webcasts of select sessions from that event are available at this site.