Telix Signs MOU with United Imaging to Standardize Theranostics Workflows Across U.S. Sites

Protocol-driven manufacturing consistency across multi-site theranostics programs is the operational challenge this MOU is designed to address. Telix Pharmaceuticals and United Imaging Healthcare North America have signed a Memorandum of Understanding to evaluate an integrated research collaboration in the U.S., with QA and regulatory implications that extend well beyond scanner selection.

The initial scope centers on TLX101-Px (Floretyrosine F 18), marketed under the provisional brand name Pixclara®, which has not yet received marketing authorization in any jurisdiction. Early workstreams will cover scanning protocol optimization, workflow support tool development and validation, and pilot programs aligned with high-impact clinical applications, a sequencing that maps directly onto process validation expectations under 21 CFR Part 211 and ICH Q10 quality system principles.

For QA directors, the collaboration's stated aim of enabling consistent, protocol-driven imaging performance across systems and sites is the operative phrase. Multi-site radiopharmaceutical programs routinely encounter variability at the scanner interface; standardized acquisition protocols tied to validated radiopharmaceutical workflows reduce that variability and strengthen the evidentiary basis for regulatory submissions. The framework also encompasses AI-enabled clinical decision support tools and connectivity infrastructure, both of which carry their own software validation obligations under 21 CFR Part 11 and applicable FDA guidance on AI/ML-based software as a medical device.

The partnership structure, an MOU with provisions for co-development, validation, and deployment, leaves room for expansion into additional Telix product candidates and markets, subject to mutual agreement. Regulatory affairs leads tracking the U.S. theranostics pipeline should note that any broadening of scope will require corresponding updates to validation packages and, where applicable, supplemental submissions tied to imaging platform specifications.

Pilot program outcomes and scanning protocol validation data will serve as the measurable checkpoints against which the collaboration's regulatory readiness can be assessed.

Source: Telix Pharmaceuticals via company press release, June 2, 2026.