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.