TODAY'S BIG THREAT
Published 18 October 2016
In a large-scale nuclear or radiological emergency, such as a nuclear detonation, hundreds of thousands of people may need medical care for injuries or illness caused by high doses of radiation. To help save as many people as possible and better prepare the nation for the health impacts of such catastrophic emergencies, the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) will sponsor late-stage development of two tests, known as biodosimetry tests, which can determine how much radiation a person’s body has absorbed.
HHS says that in a large-scale emergency involving radiation, doctors would need information about how much radiation each survivor has absorbed to determine the type of treatment the person should receive to combat any radiation injuries to internal organs and blood cells.
Although devices are available to detect radiation externally, such as on skin, there are no biodosimetry tests approved to measure the amount of radiation absorbed into the body.
ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will use authority granted under the Project BioShield Act of 2004 to support the tests’ late-stage development and potentially purchase tests from one or more of the companies for the Strategic National Stockpile. BARDA will provide more than $22.4 million over two years to DxTerity Diagnostics based near Los Angeles and more than $21.3 million over four years, three months to MRIGlobal of Kansas City, Missouri.
HHS notes that under Project BioShield, the U.S. government can support the late-stage development and procurement of new medical countermeasures — drugs, vaccines, diagnostics, and medical supplies — to mitigate the health impacts associated with chemical, biological, radiological and nuclear threats. With these two biodosimetry tests, BARDA has sponsored development or purchased twenty products using Project BioShield.
The agreements with the two companies support the clinical studies required for the companies to apply for U.S. Food and Drug Administration (FDA) approval of the biodosimetry tests. The work also allows the companies to seek Emergency Use Authorization from FDA if a nuclear or radiological incident occurs prior to full approval of the tests.
Both biodosimetry tests are being designed for use in clinical health care labs and analyze blood samples to measure how genes respond to different amounts of radiation and are expected to generate results in about eight hours and can be used up to seven days after exposure. Both are high throughput tests with the potential to process 400,000 or more tests a week.