A nuclear option: FDA approves isotope generator

Jubilant Pharma announced U.S. Food and Drug Administration (FDA) approval for a rubidium-82 generator used to deliver patient doses of rubidium for imaging procedures. Named RUBY-FILL, the device is geared towards PET myocardial perfusion imaging and is expected to be available befor the end of the year.

With a potential shortage of a technetium-99 on the horizon, radiology departments are looking for alternative imaging isotopes. Rubidium-82 is one possibility; it can be used for similar chest imaging as technetium. However, like tech-99, it has a short half-life requiring a precursor isotope (strontium) be shipped to the clinic and processed onsite to produce the usable isotope. 

However, rubidium is not a 1:1 replacement for technetium. Rubidium is used in PET imaging, which can be expensive due to the equipment involved, while technetium is used in single photon emission CT (SPECT), a much cheaper modality.

Generators like RUBY-FILL use a process called elution to decay stable isotopes into ones with the short half-lives suitable for imaging. Rubidium is primarily used to evaluate heart function in patients with coronary artery disease.

“We are proud to bring to the US market a groundbreaking, state-of-the-art technology for myocardial perfusion imaging. RUBY-FILL expands DraxImage’s nuclear medicine portfolio and is a part of our commitment to provide healthcare providers and their patients with innovative healthcare solutions for those with suspected or existing coronary artery disease,” said GP Singh, CEO of Jubilant Pharma.