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Final Phase 3 Results For General Electric Co's GE Healthcare Investigational Imaging Agent Flutemetamol Presented At Alzheimer’s Association International Conference
General Electric Co's GE Healthcare announced the final results from a phase 3 study of the investigational PET amyloid imaging agent. [18F]flutemetamol in terminally ill patients who had agreed to undergo postmortem brain autopsy.1 The data showed concordance (sensitivity and specificity) between [18F]flutemetamol PET images and beta amyloid brain histopathology. These data confirm the potential of [18F]flutemetamol as an imaging agent to detect beta amyloid plaque, a pathology associated with Alzheimer’s disease (AD), in living patients. The data were presented at the Alzheimer's Association International Conference 2012 (AAIC 2012) in Vancouver and support an application for regulatory approval of [18F]flutemetamol, which is intended to be filed later this year. [18F]Flutemetamol is a GE Healthcare PET imaging agent in development for the detection of beta amyloid deposits in the brain. The study presented at AAIC 2012 examined the autopsied brains of 68 subjects who had received [18F]flutemetamol imaging in life to detect the presence of brain beta amyloid pathology. The images were then evaluated visually by independent trained readers, and the flutemetamol retention in the brain was quantified using a standardized uptake value ratio (SUVR). The brains of subjects who subsequently died were evaluated histopathologically and compared to interpretations of flutemetamol PET scans. 18F]Flutemetamol showed the ability to detect beta amyloid with a majority read sensitivity.
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