Posted: 24 October 2025
Telix Pharmaceuticals has announced that its investigational PET imaging agent TLX250-CDx (Zircaix®, ⁸⁹Zr-DFO-girentuximab) has been included for the first time in international clinical guidelines for molecular imaging of renal masses.
Kevin Richardson, Chief Executive Officer, Precision Medicine at Telix, said, “The inclusion of TLX250-CDx in the SNMMI/EANM/ACNM guidelines represents a significant advancement for Telix and for precision oncology. Endorsement from this global multidisciplinary panel underscores the clinical value of our technology and will help accelerate its integration into patient care pathways worldwide.”
Released jointly by the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the European Association of Nuclear Medicine (EANM), and the American College of Nuclear Medicine (ACNM), the updated guidelines mark a pivotal moment in the adoption of antibody-based radiotracers for more accurate and non-invasive diagnosis of kidney cancer.
Published on the SNMMI website and in The Journal of Nuclear Medicine, the expert panel concluded that molecular imaging “offers the opportunity to more effectively characterise renal lesions and optimise patient management decisions.”
The panel noted that TLX250-CDx PET “appears to be a well-tolerated and accurate method for non-invasive identification of clear cell renal cell carcinoma (ccRCC),” supported by data from Telix’s Phase 3 ZIRCON trial. The study achieved a sensitivity of 86%, specificity of 87% and a positive predictive value of 93%, even in very small, hard-to-detect lesions. By targeting carbonic anhydrase IX (CAIX) — a protein expressed on more than 95% of ccRCC cells — TLX250-CDx provides high-contrast images and exceptional diagnostic precision.
Professor Brian Shuch, guideline author and Director of the Kidney Cancer Program at UCLA, said the inclusion of ⁸⁹Zr-girentuximab PET “reflects a shift toward precision medicine in renal cancer, providing clinicians with a more accurate tool for diagnosis to guide optimal, individualised treatment.”
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