EU approves NeuraCeq for PET Imaging of Amyloid plaque - Piramal Imaging

Piramal Imaging has announced that NeuraCeq (florbetaben 18F imaging system) has received marketing authorization from the European Commission for PET Imaging of Beta-Amyloid neuritic plaque density in the brain. Data from the pivotal Phase III autopsy study showed that PET imaging with NeuraCeq detects neuritic beta-amyloid in the brains of living subjects.

The visual subject-level PET reading proposed for routine clinical practice compared to histopathology for the first 31 brains demonstrated 100 percent sensitivity and 86 percent specificity. In a post-hoc analysis in a larger population with 74 autopsied subjects, the sensitivity of the visual assessment was 98 percent and specificity was 89 percent. NeuraCeq will be available in select European countries in the second and third quarters of 2014.