New imaging agent production system predicted to reduce shortage risk
A Beloit company’s system for producing a crucial medical imaging agent will reduce the risk of shortages and strengthen national security, according to FDA Commissioner Scott Gottlieb.
NorthStar Medical Radioisotopes recently got approval from the FDA for its RadioGenix System. This system is used to extract technetium-99, a commonly used imaging agent, from the company’s non-uranium based molybdenum-99.
“Prior to today, the production process for Tc-99m involved shipping enriched uranium out of the U.S. for irradiation,” Gottlieb said in a recent statement he made “to acknowledge the role the FDA played in the groundbreaking effort to develop a new imaging technology.”
“All of the reactors that produced this source material were located outside of the U.S. creating a complicated, at times uncertain, and potentially risky supply chain,” he said.
Technetium-99 is “the gold standard medical imaging isotope for cardiovascular diseases,” adds Stephen Merrick, who came on as chief operating officer more than two years ago.
“The beauty of Tc-99m is it gives great quality pictures, and leaves very little burden of radioactivity in the patient,” he told WisBusiness.com. “It is an extremely cost-effective form of imaging.”
Tc-99m is used in about two-thirds of of all diagnostic medical isotope procedures in the United States, according to the National Center for Biotechnology Information.
With this approval, NorthStar can now sell both the RadioGenix system and molybdenum-99, or Mo-99, to radiopharmacies.
After years of working toward approval, the company sent its final submission to the FDA last May, and approval came through in early February.
“As a result of this approval, we are the only company in the states that produces Mo-99,” said George Messina, company CEO. He stressed this new source of domestic production will stabilize the country’s supply of this crucial material.
The medical community has had serious supply issues over the last few months, but the market hasn’t moved toward alternatives, Merrick said. That’s because “there aren’t any.”
He adds, "That’s why this is so important.”
The material itself is much more stable than alternatives, which are shipped in from overseas after being manufactured in nuclear reactors using enriched uranium. Messina says this is a major benefit, as NorthStar’s production of Mo-99 doesn’t generate the kind of waste that comes with uranium production.
“Our waste is extremely benign… easy and cheap to dispose of,” he said. “Our material is a stable isotope -- it’s not radioactive. It’s as stable as a rock in your backyard.”
And shipping in unstable alternatives can lead to major waste due to decay.
NorthStar will be selling Mo-99 and the Tc99 manufacturing system to its 350 radiopharmacy customers in the next couple of months, gradually growing the amount of Mo-99 being produced.
The company currently has 130 employees on payroll, and is looking to fill 20 more positions.
“From there, as we start to expand production, more hiring will take place,” Messina added.
Expansion is planned for the product line as well, with as many as six other radioisotopes coming down the pipeline over the next few years.
--By Alex Moe