NRF-iThemba LABS and isoSolutions bring major boost to Canada's innovative diagnostic capabilities

Cape Town, South Africa and Vancouver, Canada – February 7, 2025 – The National Research Foundation’s iThemba Laboratory for Accelerator Based Sciences (NRF-iThemba LABS), in collaboration with Vancouver-based isoSolutions, announced the successful submission of a Drug Master File (DMF) for the 68Ge/68Ga Generator to Health Canada. This significant milestone marks a major advancement in the field of medical imaging, particularly in positron emission tomography (PET), and showcases the commitment of both organisations to improving diagnostic capabilities across Canada.

PET imaging is a nuclear medicine procedure that measures metabolic activity of the cells of body tissues. It is used to observe the biochemical changes in bodies of patients suffering from illnesses such as cancer and brain or heart conditions.

A product of NRF-iThemba LABS, the 68Ge/68Ga Generator is engineered to provide a reliable and efficient source of Gallium-68, a radiotracer widely used in oncological, cardiological, and neurological imaging applications. By facilitating the on-site production of Ga-68, the generator aims to enhance the accessibility of critical imaging technologies while streamlining workflows in clinical environments.

Key Benefits of the NRF-iThemba LABS 68Ge/68Ga Generator:

• Reliable supply: The generator ensures a consistent and on-demand supply of Ga-68 to address the growing needs of healthcare facilities for timely PET imaging.
• Operational efficiency: Designed for quick and effective production, the Ga-68 generator minimises patient wait times and optimises operational flow in diagnostic imaging centers.
• Cost-effectiveness: In-house radiotracer production enables the Ga-68 generator to offer a lower cost alternative which makes advanced diagnostic imaging more accessible to patients.

The review process by Health Canada paves the way for the commercialisation of the NRF-iThemba LABS’ 68Ge/68Ga Generator, with the potential for widespread adoption in diagnostic imaging facilities across the country.

As the producer, NRF-iThemba LABS has dedicated extensive resources to the research and development of the Ga-68 generator to ensure that it meets the highest standards of quality and regulatory compliance. isoSolutions, as the distributor, is committed to bringing innovative medical imaging solutions to healthcare providers across Canada, enhancing patient care through improved access to cutting-edge technologies.

“We are excited to partner with isoSolutions on this journey,” said Dr Deidre Prince, Manager of the Nuclear Medicine Department at NRF-iThemba LABS. “The 68Ge/68Ga Generator represents a significant leap forward in PET imaging technology, and we are eager to collaborate with Health Canada to bring this important tool to the market.”

Arun Singh, CEO of isoSolutions, added, “This DMF submission underscores our shared commitment to delivering high-quality imaging solutions that can transform patient care. We look forward to working closely with NRF-iThemba LABS and Health Canada to ensure the successful commercialisation of the NRF-iThemba LABS’ 68Ge/68Ga Generator.”

About NRF-iThemba LABS:

NRF-iThemba LABS is the premier research infrastructure platform for accelerator-based science and technology on the African continent. It harnesses the capabilities of accelerated particle beams beyond fundamental research through the routine production of radiopharmaceuticals for both the local and international markets. NRF-iThemba LABS is committed to empower healthcare providers with state-of-the-art diagnostic tools.

About isoSolutions:

isoSolutions is a global distributor of medical imaging and therapy products, dedicated to providing innovative solutions that improve diagnostic accuracy and patient outcomes. With a focus on collaboration and excellence, isoSolutions aims to support healthcare providers across Canada.