The U.S. National Nuclear Security Administration (NNSA) is carrying through with a pledge made earlier this year to provide $40 million more to support development of domestic commercial production of the medical isotope molybdenum-99.
The aim of the semiautonomous Department of Energy agency is to promote means of manufacturing that do not require reactors powered by highly enriched uranium, a proliferation-sensitive material that can be used in nuclear weapons.
On July 25, the NNSA issued a funding opportunity announcement for submission of applications that would lead to cooperative agreements to demonstrate and establish commercial-scale manufacturing of the isotope. The agency would provide up to four cost-matching agreements, each worth $10 million, an NNSA spokesman said Tuesday.
Applications are due 60 days from the date of the announcement. The NNSA expects to award the deals early next year.
“The applications will be evaluated based on the ability of the recipient to produce Mo-99 in the United States and establish the capability to deliver to the U.S. market at least 3,000 6-day curies of Mo-99 per week, steady state, without the use of HEU,” according to the funding announcement. “Any commercial entity which already has the capability to currently produce at least 3,000 6-day curies of Mo-99 per week, steady state, without the use of HEU, will be eliminated from consideration.”
The $40 million would come on top of $100 million the agency has already distributed for the same purpose. In each case, that involved an agreement for $25 million, to be matched by the recipients: NorthStar Medical Radioisotopes, which secured two awards worth $50 million for separate neutron-capture and accelerator-based production systems; SHINE Medical Technologies, for accelerator technology that would employ low-enriched uranium; and General Atomics, which has since abandoned its work with the University of Missouri and Nordion on selective gas technology.
The funding generally supports operations including acquisition of important equipment, facility and process design, and regulatory filings, the NNSA spokesman said.
The United States since 1989 has had no domestic production capacity for molybdenum-99, which decays into the isotope technetium-99m. That isotope is used extensively around the world for medical processes including cardiac stress tests and diagnosis of heart disease and cancers. The situation leaves the country at the mercy of foreign providers, which primarily use highly enriched uranium in production, according to the NNSA.
NorthStar and SHINE are among a number of companies competing to revive the U.S. production capability, hoping to meet a large portion or even all of the nation’s needs (enough for 40,000 procedures daily, the NNSA says).
SHINE, which is preparing to apply for a Nuclear Regulatory Commission license for operation of its production facility in Janesville, Wis., said this week it is considering applying for a cooperative agreement but has not applied.
Corvallis, Ore.-based Northwest Medical Isotopes, which in May received an NRC construction permit for a production facility in Missouri, plans next month to apply to the NNSA, Chief Operating Officer and Vice President Carolyn Haass said by email. “Otherwise, we are plugging along on our final facility design and development of the operating agreement.”
Lynchburg, Va.-based BWX Technologies, a major Energy Department contractor keen to enter the molybdenum-99 market, “evaluates opportunities like this on a case-by-case basis,” but does not disclose whether it is pursuing such agreements, according to spokesman Jud Simmons. Earlier this month, BWXT completed its acquisition of the Nordion medical isotope business from Sotera Health.
NorthStar, of Beloit, Wis., and another prospective isotope producer, Coqui RadioPharmaceuticals, did not respond by deadline to requests for comments on their plans.
However, NorthStar said in May it intended to file at least one application. The company in July received approval from the U.S. Food and Drug Administration for production of its RadioGenix System at its Beloit plant, which would process molybdenum-99 without highly enriched uranium.
