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DOE/NNSA partnership with U.S. healthcare industry results in FDA approval of domestically-produced, non-uranium based Molybdenum-99

WASHINGTON – Efforts by the U.S. Department of Energy’s National Nuclear Security Administration (DOE/NNSA) to ensure a reliable supply of a vital medical isotope have paved the way for today’s announcement by the U.S. Food and Drug Administration (FDA) on the approval of the first domestically-produced, non-uranium based molybdenum-99 (Mo-99).

Last June, President Trump outlined an initiative to “revive and expand” the U.S. nuclear sector. Today’s announcement highlights DOE/NNSA’s support of a program to reduce dependence on foreign imports and bring new opportunity to the heartland. 

Mo-99 is the parent isotope of technetium‑99m (Tc-99m), the most widely used radioisotope in medical diagnostic imaging. This essential medical radioisotope is used in approximately 80 percent of nuclear diagnostic imaging procedures, or about 40,000 medical procedures in the United States every day. Tc-99m is used to diagnose heart disease, the spread of cancer, to study organ structure and function, and to perform other important medical applications including the cardiac “nuclear stress test.”

NNSA has successfully partnered with NorthStar Medical Radioisotopes for seven years to develop the RadioGenixTM System and NorthStar’s neutron capture process to produce Mo-99 without the use of uranium.

“The FDA’s approval of NorthStar’s technology to produce Mo-99 in the United States is a win-win for national security and healthcare,” said Steven C. Erhart, DOE’s Acting Under Secretary for Nuclear Security and NNSA Administrator. “The domestic production of this critical medical isotope without highly enriched uranium reduces global proliferation threats while also providing a more reliable supply to healthcare providers that need Mo-99 for diagnostic medical procedures every single day.”

Until now, the United States has had to rely on foreign producers to import 100 percent of its Mo-99 supply, some of which use highly enriched uranium (HEU) in their production processes. NNSA efforts to eliminate the use of weapons-grade uranium from the Mo-99 production process reduce the global proliferation threat.

The American Medical Isotopes Production Act (AMIPA) of 2012 directs DOE/NNSA to implement a technology-neutral program, in cooperation with non-Federal entities, to support projects in the United States for the production of Mo-99 without HEU for medical uses.

For more information on NNSA efforts to establish a reliable supply of Mo‑99 without the use of HEU, click here