Health and Human Services Department sponsoring development of two radiation exposure tests

The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) announced Tuesday that it would sponsor the development of radiation exposure tests.

The Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, established a $25 million contract with the Menlo Park, California-based SRI International to support the development of its biodosimetry diagnostic test. The test can be used in doctors’ offices with results in approximately 30 minutes and will likely only require a few drops of blood to get results.

A two-year, $24 million contract between BARDA and Asell, Inc. of Owings Mills, Maryland will support the development of a biodosimetry test for clinical health care labs. This high-throughput diagnostic test is being developed to determine radiation levels more than 14 days after the initial dose.

“Dangerous radiation injuries are not always immediately apparent,” BARDA Director Rick Bright said. “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.”

The recent agreements support the clinical studies that the companies will use to apply for U.S. Food and Drug Administration (FDA) marketing authorization and will also allow them to seek Emergency Use Authorization from the FDA if a nuclear or radiological incident occurs before the tests receive marketing authorization.

Following their development, BARDA may purchase the diagnostics for the Strategic National Stockpile.