New results were presented this weekend on a PET radiopharmaceutical being developed by Bayer for imaging cardiac amyloidosis. The tracer turned in promising results in a paper presented at ESC 2026 and published simultaneously in JAMA.
Cardiac amyloidosis occurs when abnormal proteins called amyloid fibrils build up in heart tissue, eventually leading to heart failure and death. It was once thought to be untreatable, but new pharmaceutical therapies have become available that slow disease progression and improve patient outcomes.
- But first you have to make a diagnosis, and that’s been the hard part. Multiple imaging modalities are often required, and patients with cardiac amyloidosis often experience diagnostic delays of one to two years or more.
Enter Bayer, which earlier this year acquired a pair of radiopharmaceuticals from Attralus, one for PET imaging and the other for SPECT. The PET agent is iodine-124 evuzamitide, a radiolabeled synthetic peptide that binds to the amyloid fibrils that characterize cardiac amyloidosis.
- The acquisition was a bit of a departure for Bayer, which until the purchase had focused its imaging business mostly on contrast agents for X-ray, CT, and MRI.
But the results presented over the weekend from the Phase III REVEAL trial indicate Bayer may have placed a good bet.
- Researchers enrolled 170 patients from 18 U.S. centers who got PET/CT scans with iodine-124 evuzamitide. Three physicians with experience in cardiac PET/CT reviewed the results.
The REVEAL investigators discovered…
- Iodine-124 evuzamitide had 94% sensitivity for cardiac amyloidosis, with 86% specificity.
- Positive predictive value was 85%, and negative predictive value was 94%.
- The radiotracer showed high diagnostic accuracy for both types of cardiac amyloidosis, light chain (AL) and transthyretin (ATTR) amyloidosis.
- The radiotracer was well tolerated by patients.
The findings indicate that iodine-124 evuzamitide has potential “as a reliable first-line test to exclude cardiac amyloidosis,” meaning it could rule out the need for invasive biopsy.
- What next for the tracer? Bayer said it would be discussing the REVEAL data as well as regulatory submissions with the FDA and other health authorities.
The Takeaway
New results from REVEAL indicate that Bayer’s iodine-124 evuzamitide PET radiotracer has the potential to fundamentally change the diagnosis of cardiac amyloidosis, historically one of the more challenging heart conditions to detect and manage.
