PSMA-PET imaging

Telix Pharmaceuticals has dosed the first U.S. patient in its Phase 3 BiPASS trial, evaluating PSMA-PET imaging agents for prostate cancer diagnosis. The study aims to assess if combining MRI with Illuccix®/Gozellix® PSMA-PET imaging can improve accuracy and reduce the need for invasive biopsies, which are often negative. This trial seeks marketing authorization for pre-biopsy PSMA-PET imaging, potentially offering a less invasive diagnostic pathway for many patients.

Telix’s Gozellix receives Transitional Pass-Through (TPT) status from CMS, enabling separate reimbursement under HOPPS and eliminating 20% patient coinsurance starting October 1, 2025. Gozellix offers longer shelf life, broader distribution, and flexible production, improving PSMA-PET imaging accessibility for prostate cancer. While it advances diagnostics, potential risks include image misinterpretation, radiation exposure, and variable performance based on PSA levels. TPT status may significantly boost Telix’s market position.