Bayer's investigational PET tracer shows high accuracy for cardiac amyloidosis
An investigational PET radiotracer could offer a new imaging approach for cardiac amyloidosis, which can be difficult to diagnose, according to new data presented during the 2026 European Society of Cardiology Congress.
Bayer announced results from the investigator-initiated REVEAL study Aug. 30 during the conference. The multicenter trial evaluated iodine 124 evuzamitide in 170 adults with suspected cardiac amyloidosis across 18 U.S. centers. The investigational tracer is designed to bind with amyloid and provide a direct imaging assessment of cardiac amyloid deposits.
Diagnosing cardiac amyloidosis has historically been challenging, making managing patients’ symptoms difficult as well. The condition results from amyloid protein accumulation in the heart, which can cause myocardial thickening and stiffness and degrade cardiac function. Delayed diagnosis is common, and patients often have to undergo multiple tests before receiving a definitive prognosis.
“For people with cardiac amyloidosis, obtaining an accurate diagnosis can be challenging,” REVEAL principal investigator Sharmila Dorbala, MD, MPH, director of nuclear cardiology at Brigham and Women’s Hospital, said in a statement. “These challenges can lead to delays, underdiagnosis or misdiagnosis in the course of the disease.”
For the study, participants received a single intravenous dose of iodine 124 evuzamitide followed by cardiac and partial-body PET/CT imaging three to five hours later. Readers evaluated whether cardiac tracer uptake was present or absent while blinded to clinical information.
According to the presentation, the study met its primary endpoints for sensitivity and specificity based on visual interpretation of PET scans by three independent readers. On the majority read, in which at least two of three readers agreed, the tracer demonstrated 94% sensitivity and 86% specificity for cardiac amyloidosis. Diagnostic performance remained strong when researchers evaluated the two major forms of the disease. For transthyretin amyloidosis, sensitivity was 96% and specificity was 86%, while the tracer achieved a sensitivity of 95% and specificity of 86% for light-chain amyloidosis.
The tracer’s safety profile was favorable as well. Among 170 participants, 32.4% experienced an adverse event within 30 days, although only one event, fatigue, was considered related to the tracer. No deaths or tracer-related adverse events leading to discontinuation occurred.
Iodine 124 evuzamitide has received the FDA Breakthrough Therapy designation and U.S. and European Union orphan drug status, but it remains investigational. Bayer soon plans to discuss the phase 3 results and a potential regulatory submission with the FDA and other health authorities.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.