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United States : HHS sponsors development of two tests for radiation exposure.

The U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR) is advancing the development of two tests to determine how much radiation peoples bodies have absorbed, including a point-of-care test, which could help doctors better determine whether patients need treatment soon after a radiation exposure.

Dangerous radiation injuries are not always immediately apparent, explained BARDA Director Rick Bright, Ph.D. Biodosimetry tests to measure absorbed radiation are critical in ensuring that people receive the appropriate medical care following radiation exposure and are an important component of our preparedness against national security threats.

In a large-scale nuclear or radiological emergency, doctors will 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.

A 26-month, $25 million contract with the Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, and SRI International based in Menlo Park, California, will advance the development of its biodosimetry diagnostic test to be performed in doctors offices with results in approximately 30 minutes.

With radiation injuries, a person can appear healthy initially, yet several days later symptoms may become evident. If successful, the test being developing could help physicians determine whether patients have absorbed a dose of radiation requiring urgent care. Studies to date show that the test would require only a few drops of blood to produce results.

In addition, a 2-year, $24 million contract between BARDA and Asell, Inc. of Owings Mills, Maryland, will advance the development of a biodosimetry test for use in clinical health care labs. While other laboratory tests in development may be able to determine an absorbed dose for about one week post-exposure, the high-throughput diagnostic test is being developed to determine how much radiation a patients body has absorbed more than 14 days after the initial dose.

BARDA will use authority granted under the Project BioShield Act of 2004 to support the tests late-stage development and potentially purchase the diagnostics for the Strategic National Stockpile.

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 additional biodosimetry tests, BARDA has supported 27 products using Project BioShield.

Todays agreements support the clinical studies that the companies will use when applying for U.S. Food and Drug Administration marketing authorization 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 marketing authorization of the tests.

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 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. 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.

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Publication:Mena Report
Date:Oct 4, 2017
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