Bayer has reported that iodine 124 evuzamitide met both primary endpoints in the Phase III REVEAL study, demonstrating sufficient sensitivity and specificity for cardiac amyloidosis PET imaging by visual scan interpretation — results that could support the first FDA-approved diagnostic agent specifically labeled for the condition.
The long-standing diagnostic need
Cardiac amyloidosis is caused by the accumulation of misfolded proteins in heart tissue, progressively impairing cardiac function and leading to heart failure, frequent hospitalization, and early mortality. Despite growing clinical awareness, the disease carries a diagnostic delay of roughly two to four years from symptom onset, with patients typically consulting multiple specialists and undergoing several imaging procedures before receiving an accurate diagnosis.