Telix Pharmaceuticals has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for a new prostate-specific membrane antigen (PSMA)-PET cold kit for prostate cancer imaging.
Called TLX007-CDx, the kit enables more flexible production, including with gallium-68 (Ga-68) sourced from both newer high-activity generators and cyclotrons powered by ARTMS’ Quantm irradiation system and GE HealthCare’s FASTlab solid and liquid target production system.
The new kit is expected to further expand the availability, distribution, and scheduling flexibility of PSMA-PET imaging, Telix said.
![Pittsburgh Compound B (PiB) PET distribution volume ratio (DVR) images were projected onto fsaverage surfaces from FreeSurfer and surface smoothed, with PiB (amyloid) slope maps created using ordinary least squares regression (time as only factor) and mixed effects models for 154 participants run at each vertex (P < .01; model: longitudinal Geriatric Depression Scale score estimated by amyloid slope × time + [sex + education + age] × time). This map visualizes the results of the linear mixed-effects models (t score of the main variable, amyloid slope × time) such that regions with a greater t score (red) represent areas in which greater depressive symptoms are associated with greater amyloid accumulation (amyloid slope). Anatomical landmarks are provided: L refers to the left hemisphere, R refers to the right hemisphere, and additional labels indicate the anterior and posterior ends of the brain. Images available for republishing under Creative Commons license (CC BY 4.0 DEED, Attribution 4.0 International) and courtesy of JAMA Open Network.](https://img.auntminnie.com/files/base/smg/all/image/2024/08/PET_depression.66cf997f7e441.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
