FDA signs off on NorthStar’s Tc-99m, first nonuranium-based isotope for Dx imaging

The FDA and the U.S. Nuclear Regulatory Agency signed off on NorthStar’s Tc-99m to develop nonuranium-based isotopes for medical imaging. (FDA)

The FDA and the Nuclear Regulatory Agency have cleared the use of NorthStar Medical’s RadioGenix system to produce technetium-99m (Tc-99m), giving the U.S. its own source of the isotope for the first time in three decades, the agencies said.

The isotope, which is widely used in radiology as an imaging tracer, is a byproduct of highly enriched uranium, which has only been available recently from foreign supplies in Canada, Poland, South Africa and a handful of other sources. The limited supply and difficult logistics of importing radioactive materials into the U.S. have, in the past, resulted in shortages and high prices.

The RadioGenix system from NorthStar, based in Beloit, Wisconsin, produces technetium-99m from nonuranium-sourced molybdenum-99 (Mo-99). The Mo-99 decays into Tc-99m, and then ozone is used to sterilize the radioisotope and prepare the final product, the sodium pertechnetate Tc-99m injection.

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“This new technology was the result of a broad collaboration across the federal government and industry, and has the potential to benefit many patients as well as restore the U.S. ability to domestically supply a critical medical diagnostic tool for the first time in 30 years,” Scott Gottlieb, M.D., the FDA commissioner, said in a statement. “The system we’ve approved today will not only help save and improve the lives of patients, but will reduce the risk of drug shortages and strengthen our national security by creating a U.S.-based manufacturing capacity that is less vulnerable to supply disruptions.”

Tc-99 is used in more than 80% of routine medical imaging procedures, or about 50,000 procedures a day in the U.S., the agency said. Because the isotope has a limited shelf life, a stable supply chain is critical, Gottlieb added.

“We are extremely proud to pioneer domestic production of Mo-99 that is independent of uranium-based product,” George P. Messina, chairman and CEO of NorthStar, said in a statement. “The approval by the FDA will reduce the U.S. healthcare system’s reliance on fragile foreign supply … and the use of enriched uranium target material.”

The company said RadioGenix's technology has the potential to apply its separation capabilities at the point of care to other radioisotopes, including therapeutic isotopes such as actinium-225/bismuth-213, which will require FDA approval.