The US Food and Drug Administration (FDA) has approved NorthStar Medical Radioisotopes’ RadioGenix System for the production of a common medical isotope called technetium-99 (Tc-99m) from the firm’s non-uranium based molybdenum-99 (Mo-99).
Tc-99m is used in more than 80% of routine diagnostic imaging procedures to detect various conditions such as cancer and heart diseases. The imaging agent, however, comes with a limited shelf life and requires stable supply.
Tc-99m production currently requires shipping of enriched uranium out of the country for irradiation, resulting in unreliable and risky supply chain as foreign facilities are vulnerable to unexpected shutdowns or closures.
Such frequent occurrences or threat of disruptions has reportedly led to the adoption of alternative isotopes that are expensive or of a higher dose.
According to the FDA, the newly approved system will improve patient lives, as well as minimise the drug shortage risk by offering a local manufacturing capacity that is comparatively less prone to disruptions.
In a statement, FDA commissioner Scott Gottlieb said: “The goal was to eliminate the export of highly enriched uranium (HEU) from the US for the purposes of medical isotope production and ensure a reliable domestic supply of the isotope.
“Since 2009, the Department of Energy’s National Nuclear Security Administration has signed cooperative agreements with several private-sector companies to develop domestic production of Mo-99 without the use of HEU.”
Said to be the first US producer of Mo-99 in more than 25 years, NorthStar Medical says that RadioGenix System performs automated, on-site separation and preparation of US Pharmacopeia (USP) Sodium Pertechnetate Tc 99m Injection from Mo-99.
The firm expects that the system’s separation capabilities can be used in the future at the point-of-care to additional radioisotopes such as therapeutic actinium-225 / bismuth-213 isotopes.