The RadioGenix System was developed when the federal government and industry collaborated to move the technology forward. This technology has the potential to restore the U.S’s ability to domestically supply a critical medical diagnostic tool for the first time in 30 years.
The RadioGenix System a novel manufacturing system used to produce radioisotopes called Technetium-99m (Tc-99m), plays an important role in nuclear imaging studies for a wide range of uses including cancer and cardiology.
It is used in more than 80 percent of routine medical imaging procedures relied on by 50,000 Americans every day but because the imaging agent has a limited shelf life, a stable supply chain is critical and not always easy to obtain.
On February 8, 2018, the FDA https://www.fda.gov approval for the RadioGenix System was granted to Northstar Medical Radioisotopes https://www.northstarnm.com to help reduce the risk of drug shortages and strengthen security by creating a U.S based manufacturing capacity so the medical community is less vulnerable to supply disruptions.
Tc-99m involves shipping enriched uranium outside of the U.S. for irradiation and then shipping the material back to the U.S This has created a complicated at times uncertain and potentially risky supply chain.
The only solution was to ship the material back to the U.S in the form of Molybdenum-99 or referred to as Mo-99 but this has proven to be expensive. As a result, clinicians have shifted to alternative isotopes that may be more expensive or may expose patients to higher doses of radiation.
As FDA Commissioner Scott Gottlieb, MD, explains, “The FDA’s Center for Drug Evaluation and Research and the Center for Devices and Radiological Health, have worked closely with both industry and other U.S. government colleagues including the Nuclear Regulatory Commission (NRC)” https://www.nrc.gov to help solve the problem of how the U.S can effectively and in a safe manner use the RadioGenix System to produce radioisotopes.
The Commissioner announced, “The NRC will be issuing guidance to their licensees who want to possess and use the RadioGenix System with the goal to bring a secure, clean, and stable supply of the Tc-99m radioisotope to the medical community”.