Eden Radioisotopes has filed a construction permit application with the Nuclear Regulatory Commission for a facility to produce medical radioisotopes, primarily molybdenum-99 and lutetium-177.

The United States has lacked a reliable domestic source of Mo-99 for diagnostic imaging for decades, and has invested in infrastructure in South Africa, the Netherlands, and Belgium to assist facilities in producing the isotope using HALEU targets. These reactors are old, and there have been disruptions to the supply chain due to unplanned outages for repairs. With a 66-hour half-life, Mo-99 cannot be stockpiled.

After more than a decade of global efforts led by the Department of Energy’s National Nuclear Security Administration, all four major medical producers of the radioisotope molybdenum-99 for the U.S. market are now using low-enriched uranium (LEU) in their production processes instead of high-enriched uranium (HEU), the latter of which presents risks of nuclear weapons proliferation.

The Nuclear Regulatory Commission has issued its final safety evaluation report (SER) related to the operating license application for SHINE Technologies' large-scale medical isotope production facility, known as The Chrysalis, in Janesville, Wis. The SER documents the results of NRC staff’s technical and safety review of SHINE’s application. SHINE announced the NRC’s decision on February 27.

A record of decision concerning the proposed issuance of the operating license will be published by the NRC at a future date.

The Monday session “Advancement in Medical Isotopes Production and Applications” of the 2020 ANS Virtual Winter Meeting was sponsored by the Isotopes & Radiation Division and co-chaired by Lin-Wen Hu of Massachusetts Institute of Technology and James Bowen of Pacific Northwest National Laboratory.

Radioisotopes produced from nuclear reactors and accelerators are widely used for medical diagnostics and cancer therapy. Technetium-99m (decay product of molybdenum-99), for example, is used in more than 80 percent of nuclear medicine diagnostic procedures. The session featured speakers who discussed the advancement and status of domestic production and applications of medical isotopes.

Shine Medical Technologies, which is building a medical isotope production facility in Janesville, Wis., said on May 11 that it expects to have an operating license issued by the Nuclear Regulatory Commission by October 2021. Shine’s application seeking approval to operate the facility, which will produce isotopes including molybdenum-99, was accepted and docketed by the NRC last October. Mo-99, the precursor to technetium-99m, is used in more than 40 million medical patient procedures every year.

Belgium’s National Institute of Radioelements (IRE) announced on April 30 that it has produced its first batch of commercial molybdenum-99 from low-enriched uranium (LEU) targets. The first batch of Mo-99, whose decay product, technetium-99m, is used in nuclear medicine for diagnostic imaging, was produced for the U.S. health market. IRE said that the conversion to LEU represents a key milestone for the institute in the global commitment to end the civilian use of highly enriched uranium (HEU) for the production of Mo-99.

The U.S. healthcare industry is warning that the COVID-19 pandemic may threaten supplies of the medical radioisotope molybdenum-99, whose decay product, technetium-99m, is considered the workhorse isotope in nuclear medicine for diagnostic imaging. The online magazine Radiology Business recently reported that the American Society of Nuclear Cardiology (ASNC) alerted its members on April 1 that it is monitoring supply shortages of Mo-99 “more closely than ever” during the pandemic.