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News
A new PET/CT imaging agent, 124I-evuzamitide, outperformed the current standard bone scintigraphy in detecting early cardiac amyloidosis, according to phase III REVEAL study results. The tracer detected both AL and ATTR amyloidosis with high sensitivity and specificity — without the need for a biopsy. Bayer plans to submit it for FDA approval.
Diagnosing cardiac amyloidosis early has long been a challenge — current bone scintigraphy imaging misses too many early cases, leaving patients without timely access to life-changing therapies. Now, a new PET/CT tracer called 124I-evuzamitide is changing that picture. Phase III REVEAL study results, presented at the Heart Failure Society of America (HFSA) 2026 annual meeting, showed the tracer detected cardiac amyloidosis with 93.5% sensitivity and 86.0% specificity — and crucially, it worked across both major subtypes (AL and ATTR) without requiring a biopsy.
Where evuzamitide really shines is in early, low-burden disease. It identified early ATTR in 93% of cases vs. just 68% with bone scintigraphy — a meaningful leap for patients who currently fall through the diagnostic cracks. The tracer also showed promise as a tool to quantify and track amyloid burden over time, potentially serving as a treatment response marker.
Why it matters: With multiple disease-modifying therapies now available for ATTR, catching the disease early is critical for better outcomes. Evuzamitide could fill a major diagnostic gap — and Bayer's planned FDA submission means this tool may soon be in clinicians' hands.
