Singapore, Sept. 30 -- Australia-based Telix Pharmaceuticals has announced that the United States (US) Food and Drug Administration (FDA) has granted Fast Track designation for the company's BiPASS(R) programme. BiPASS (Biopsy of the Prostate Avoidance Stratification Study) is evaluating gallium-68 (68Ga) PSMA-PET imaging in combination with MRI for the detection of prostate cancer prior to biopsy.

Biopsy can be stressful and painful for patients and may provide no meaningful diagnostic benefit, highlighting the importance of improved diagnostic tools earlier in the patient journey.

Telix recently completed enrollment in the Phase 3 BiPASS study of its proprietary 68Ga-PSMA-PET agents, Illuccix(R) and Gozellix(R) for pre-biopsy prostate...