Gozellix PSMA PET Prep Kit Approved by FDA
What happened
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.
Why it matters
- 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
Key numbers
- The FDA has approved Gozellix (TLX007-CDx), a new preparation kit for PSMA PET imaging in prostate cancer patients.
- - 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.
- Manufacturer Telix estimates the product's six-hour shelf life will allow delivery to up to 20% of U.S.
What happens next
- Manufacturer Telix estimates the product's six-hour shelf life will allow delivery to up to 20% of U.S.
- This logistical improvement is expected to benefit imaging operations, particularly those in mobile or remote settings where supply chain efficiency is critical.
Quick answers
What happened in 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.
Why does Gozellix PSMA PET Prep Kit Approved by FDA matter?
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
