Radiotracer quality control system receives FDA validation

The FDA-funded validation project of Tracer-QC at the University of California, San Francisco, has now been successfully completed, according to LabLogic and Trace-Ability.

Trace-Ability ceo Arkadij Elizarov said: “We have been working tirelessly over the past three years to get to this stage. Tracer-QC has undergone considerable scrutiny to ensure that the system and the process is validated for each of the 11 quality control tests. During this period we have continually adapted and modified the system to ensure it meets the high standards set by the FDA.”

The FDA-funded project focused on validating the quality control test criteria for FDG, as well as the system itself and the workflow of Tracer-QC. “We also had to consider the various FDG formulations that may be used and how Tracer-QC would adapt,” Elizarov said.

LabLogic Systems sales director Elvir Zahirovic said: “Since we launched the concept there has been significant interest from facilities all over the world. People are excited about the potential of implementing an automated, de-skilled, reproducible and cost-effective QC solution. However, understandably validation is the biggest concern for our potential customers.

“After this successful validation, the impetus is on the leaders of the facilities around the world to make the most of this new product.”

Picture: Tracer-QC offers automated quality control of PET/SPECT radiotracers.

Published on page 13 of the September 2019 issue of RAD Magazine.

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