Gozellix PSMA PET Prep Kit Approved by FDA
The FDA has approved Gozellix (TLX007-CDx), a new preparation kit for PSMA PET imaging in prostate cancer patients. The product features an extended shelf life for gallium-based radiopharmaceuticals. This logistical improvement is expected to benefit imaging operations, particularly those in mobile or remote settings where supply chain efficiency is critical.
- The Centers for Medicare & Medicaid Services (CMS) has issued a permanent Healthcare Common Procedure Coding System (HCPCS) code, A9616, for Gozellix, effective October 1, 2025, a key step for provider billing and reimbursement. - Gozellix enters a competitive PSMA PET agent market that includes Pylarify from Lantheus and Posluma from Blue Earth Diagnostics. - Manufacturer Telix estimates the product's six-hour shelf life will allow delivery to up to 20% of U.S. PET scanners that are currently beyond the distribution reach of other PSMA imaging agents. - This is the second PSMA-PET imaging agent from Telix, which previously launched Illuccix, signaling a deep corporate focus on the growing prostate cancer imaging segment. - The approval addresses a market
