GE presents newly approved molecular agent

December 3, 2008

GE Healthcare debuted at RSNA 2008 a recently FDA-approved molecular imaging agent that homes in on rare neuroendocrine tumors. The new agent, technically known as Iobenguane I 123 Injection, was approved earlier this year for use in diagnosis and during follow-up of patients with these tumors, if relapse or recurrence is suspected, according to GE, which began shipping the product in late October.

GE Healthcare debuted at RSNA 2008 a recently FDA-approved molecular imaging agent that homes in on rare neuroendocrine tumors. The new agent, technically known as Iobenguane I 123 Injection, was approved earlier this year for use in diagnosis and during follow-up of patients with these tumors, if relapse or recurrence is suspected, according to GE, which began shipping the product in late October.

The agent promises to have a major impact on the diagnosis of children with neuroblastoma, the most common extracranial solid tumor of young children up to five years of age. It will also provide reliable imaging data to aid in identifying primary and metastatic pheochromocytoma, a predominantly adult tumor that often presents diagnostic challenges. These two diseases can be difficult to detect at an early stage because symptoms may be nonspecific when the tumors are small.

GE Healthcare began developing AdreView in 2004. It was granted orphan drug status by the FDA in December 2006. In May 2008, AdreView received priority review status from the FDA.