RUBY-FILL is intended for use in cardiac PET imaging under rest or pharmacologic stress conditions. Credit: moxumbic / Shutterstock.com.

Jubilant DraxImage (Jubilant Radiopharma) has secured approval from the US Food and Drug Administration (FDA) for its RUBY Rubidium Elution System and Rubidium Rb82 generator (RUBY-FILL) to be used in mobile settings.

RUBY-FILL is intended for use in cardiac PET imaging under rest or pharmacologic stress conditions for assessing regional myocardial perfusion in patients with suspected or existing coronary artery disease.

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The latest approval allows the company to expand cardiac PET use into smaller community hospitals, rural settings and areas where a full-time programme for cardiac PET is not available.

RUBY-FILL is a closed system designed to produce rubidium chloride injection for intravenous use.

The radioactive diagnostic agent Rubidium chloride injection is developed for positron emission tomography (PET) imaging of the myocardium.

Jubilant Radiopharma radiopharmaceuticals division president Sergio Calvo said: “The approval for mobile use with RUBY-FILL for cardiac PET is another example of Jubilant Radiopharma’s ongoing commitment to expand this imaging modality and increase patient access to this crucial test.”

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Jubilant Radiopharma partnered with healthcare providers throughout the US to establish and expand cardiac PET programmes after FDA approval in 2016.

Meanwhile, Jubilant Radiopharma collaborated with Evergreen Theragnostics for the preparation, sale and distribution of OCTEVY (Kit for Preparation of Ga 68 DOTATOC Injection) to customers throughout the US.

Currently, OCTEVY is under assessment by the FDA as a potential radioactive diagnostic agent for use with PET to localise somatostatin receptor-positive neuroendocrine tumours in paediatric and adult patients.

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