FDA Approves the RadioGenix System for Producing Technetium-99m

US medical community will now have a domestic source of Tc-99m through the use of the system that marks the first non-uranium process for the production of Mo-99 to prepare the Tc-99m

On 8 February 2018, the US Food and Drug Administration (FDA) and the Nuclear Regulatory Commission (NRC) took steps to ensure a stable and secure supply of a critical radioactive imaging product. The FDA approved the RadioGenix System, a unique system for producing Technetium-99m (Tc-99m), the most widely used radioisotope in medical imaging. The NRC is issuing guidance and will license the RadioGenix System to enable the Tc-99m it produces to be used for its medical purpose.

Tc-99m is a diagnostic agent that is used by healthcare professionals with FDA-approved imaging devices to detect potential diseases like cancer and coronary artery disease, as well as evaluating lung, liver, kidney and brain function. When used with the appropriate diagnostic scanner device, such as a SPECT imaging system, the Tc-99m emits signals that are captured and produces an image of internal organs to detect various medical problems and contribute to diagnosis and treatment decisions.

Tc-99m has been in use as a medical imaging diagnostic agent for decades and is used in more than 80% of nuclear medicine imaging procedures in the US. Before the current approval, Molybdenum-99, or Mo-99, the parent of Tc-99m, could only be produced from enriched uranium by several facilities outside of the US. This required a complicated supply chain that involved shipping enriched uranium from the US. This left the US vulnerable to possible shortages and/or supply chain issues. Because of frequent supply disruptions – or even the threat of disruptions – clinicians have shifted to alternative isotopes that may be more expensive or may expose patients to higher doses of radiation. This was the case during two supply disruptions in 2009 and 2010.

To address these challenges, the US Congress enacted the American Medical Isotopes Production Act of 2012, which contained provisions to eliminate the use of highly enriched uranium for medical isotope production and encouraged the development of US domestic supplies of Mo-99 and associated isotopes. As such, multiple US federal agencies – including the FDA, NRC, as well as the Department of Energy’s National Nuclear Security Administration and National Laboratories, among others – have been working together with industry for several years to develop a technology that helps to minimise the industry’s dependence on highly enriched uranium and brings the supply chain within the US. As a result of this collaboration, the US medical community will now have a domestic source of Tc-99m through the use of the RadioGenix System, which marks the first non-uranium process for the production of Mo-99 to prepare the Tc-99m.

As the regulatory authority responsible for overseeing the production, distribution, possession and use of radioactive materials and products containing radioactive materials, NRC is issuing guidance that will advise medical and commercial nuclear pharmacy users on the license amendments they will need to possess and use the RadioGenix System.

The latest actions granted approval for the RadioGenix System to produce sodium pertechnetate Tc-99m injection to be injected intravenously, instilled into the bladder or eye, or used with other FDA approved imaging drugs to examine specific tissues and organs.

This approval did not require new clinical studies because it relied on safety and efficacy information and data from an already FDA-approved Tc-99m generator.

The most common side effects of Tc-99m include allergic reactions, including anaphylaxis, that have been reported infrequently following the administration of sodium pertechnetate Tc-99m injection. Healthcare providers should monitor all patients for hypersensitivity reactions.

Sodium pertechnetate Tc-99m injection contributes to a patient’s long-term cumulative radiation exposure. Healthcare providers should ensure safe handling to protect patients and healthcare workers from unintentional radiation exposure in accordance with instructions for use in the product labelling.

The approval of RadioGenix System was granted to NorthStar Medical Radioisotopes.