(Released 5 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’ Office of the Assistant Secretary for Preparedness and Response (ASPR) will sponsor late-stage development of two tests, known as biodosimetry tests, that can determine how much radiation a person’s body has absorbed.
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.
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 20 products using Project BioShield.
Today’s agreements support the clinical studies required for the companies to apply for U.S. Food and Drug Administration 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.
As a division of ASPR, BARDA takes a comprehensive integrated portfolio approach to advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza and other emerging infectious diseases, and antimicrobial resistant pathogens.
ASPR partners with other federal agencies, in particular the National Institutes of Health, as well as private industry to develop medical products needed to mitigate the health effects of disasters and other public health emergencies. Potential products may transition from basic research and early clinical trials at NIH to BARDA for support of the advanced development necessary to support approval or licensure by the U.S. Food and Drug Administration.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
For more information on national public health and medical preparedness, visit www.phe.gov and to learn more about partnering with BARDA in developing medical products needed for public health emergencies visit www.medicalcountermeasures.gov.
HHS Press Office
Released by U.S. Department of Health & Human Services. Click here for source.