A new radiotracer called 124I-evuzamitide could transform how doctors detect cardiac amyloidosis. In the phase 3 REVEAL trial, the PET/CT agent showed 93.5% sensitivity and 86% specificity — and spotted early disease far more often than the current standard, bone scintigraphy. Bayer plans to submit it for FDA approval.
Cardiac amyloidosis (ATTR-CM) is notoriously hard to catch early — its symptoms mimic more common conditions, and existing imaging tools miss a significant chunk of early cases. That could be about to change. At the Heart Failure Society of America Annual Scientific Meeting, researchers presented phase 3 data on 124I-evuzamitide, an investigational PET/CT radiotracer that binds directly to amyloid deposits wherever they are in the body.
In the REVEAL trial — a prospective, multicenter, single-arm study of 170 patients with suspected ATTR-CM — the tracer demonstrated strong diagnostic performance and, crucially, outperformed bone scintigraphy in identifying early, low-burden disease (93% vs. 68%). It also detected both AL and ATTR amyloidosis with similar accuracy, making it a true pan-amyloid imaging tool. Eight patients who tested negative on bone scintigraphy were found positive on evuzamitide PET and subsequently started therapy. Bayer has announced plans to seek FDA approval.
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Why it matters: Early diagnosis of ATTR-CM is critical because current disease-modifying therapies work best before significant amyloid burden accumulates. A single, noninvasive test that reliably identifies and quantifies amyloid — and can potentially track treatment response over time — could be a meaningful step forward for both clinicians and patients.
