LabLogic and Trace-Ability are proud to announce that the FDA funded validation project of Tracer-QC at the University of California, San Francisco (UCSF) has now been successfully completed.
Arkadij Elizarov, CEO at Trace-Ability 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 had to consider the various FDG formulations that may be used and how Tracer-QC would adapt.
I would like to thank the FDA for their continued support, as well as the teams at UCSF, LabLogic and Trace-Ability for their ongoing commitment to the project. I am now extremely excited to see Tracer-QC reach its full potential.”
Elvir Zahirovic, Sales Director at LabLogic Systems said “This news is huge for us. Ever since we launched the concept there has been significant interest from facilities all over the world. Obviously people were excited about the potential of implementing an automated, deskilled, reproducible and cost-effective QC solution. Understandably validation was the biggest concern for our potential customers.
Now we have successfully completed the validation project, the impetus is on the leaders of the facilities around the world to make the most of this revolutionary new product. I am sure that in years to come we will look back on this and view it as the beginning of a new era in the quality control of radiopharmaceuticals.”