A good deal of advanced medical imaging to spot cancer tumors, and help to diagnose coronary artery disease and other conditions, relies on injecting radioisotopes into the body whose location can be tracked. The most common is technetium-99m (Tc-99m), but it has been in short supply because there are only a few nuclear power stations around the world making it as a byproduct of highly-enriched uranium, but new technologies are maturing that can help avoid many of the radioisotope sourcing issues that exist to prevent nuclear weapon proliferation and guarantee safety.
The FDA and the Nuclear Regulatory Commission (NRC) of the United States has just put out some pretty big news, approving the compact RadioGenix System from NorthStar, a Beloit, Wisconsin firm, to produce technetium-99m from non-uranium sourced molybdenum-99 (Mo-99).
This is the first time in at least 30 years that America will have its own source of Tc-99m, as it was previously available only from Canada, Poland, South Africa, and a few other places. Delivering the radioactive material from afar is a logistical nightmare that drives up the cost of the radioisotope by the time it reaches a U.S. imaging center.
The RadioGenix System produces Mo-99, which then decays into Tc-99m, and then uses ozone to sterilize the radioisotope and prepare the final product, sodium pertechnetate Tc-99m injection. We don’t have details on exactly how Mo-99 itself is produced, but that may very well be a secret that neither NorthStar nor the Nuclear Regulatory Commission want to be out there.
Flashbacks: Lantheus Announces First Technetium-99m Isotope Generator from Low Enriched Uranium…; Project Aims for Medical Isotope Production Without Use of Nuclear Reactors…; New Radioisotope Supplier to Fill Gaping Hole in Market…; New South African Source for Molybdenum-99 to Soothe Supply Worries in Medical Radioisotope Market…
Product page: RadioGenix System…
Via: FDA