18F Flutemetamol (GE HealthCare) Beta Amyloid studies positive
GE Healthcare announced pooled results from Phase III brain autopsy and biopsy studies on the investigational PET amyloid imaging agent, [18F]flutemetamol, which showed a strong concordance between [18F]flutemetamol images and Alzheimer's disease-associated beta amyloid brain pathology.For patients from four separate biopsy studies [18F]flutemetamol detected beta amyloid with a median sensitivity ranging from 75-100 percent and specificity ranging from 99-100 percent. A similar range was also found for autopsied subjects. Further, the visual assessment of all images showed a high level of agreement among readers.
The data was presented at the 16th Congress of the European Federation of Neurological Societies (EFNS) in Stockholm, Sweden, and provide support for an application for regulatory approval of [18F]flutemetamol, which is intended to be filed in the US and EU later this year.