FDA approves first use of Tracer-QC automated PET-QC solution
24 April 2018
The FDA have approved the Tracer-QC for [N-13] Ammonia release testing
LabLogic and Trace-Ability Inc. are pleased to announce the U.S. Food and Drug Administration (FDA) have allowed the first use of the Tracer-QC automated PET-QC solution for release testing of an imaging agent used in Positron Emission Tomography (PET) - [N-13] Ammonia for injection.
Massachusetts General Hospital (MGH) has led the way in adopting the innovative Tracer-QC solution. At the MGH the Tracer-QC was validated for performance of two of the release tests for [N-13] Ammonia, a well-known FDA-approved PET tracer used in cardiac imaging.
The Tracer-QC solution completely automates the traditional PET tracer release testing process, known for its complexity, subjectivity and high-skill requirements. This allows for substantial enhancements to efficiency, ease of compliance, and radiation safety.
Daniel Yokell, Associate Director for Radiopharmacy and Regulatory Affairs at the MGH Gordon Center said "Our goal is to help the industry transition to a more streamlined PET drug production and quality control workflow" and that "In turn we can hopefully expand patient access to these critical diagnostic procedures outside of large academic medical centers."
Arkadij Elizarov, CEO of Trace-Ability, praised the news and looked to the future for the innovative automated PET-QC solution "Despite the clear value of Tracer-QC confirmed by PET drug manufacturers, there has been some reluctance to adopt the technology due to its fundamental novelty and lack of precedent with the FDA. We appreciate the eagerness with which the MGH team participated in this project, which led to the first FDA approval of Tracer-QC use today. By addressing the major concern about Tracer-QC, this approval by the FDA paves the way for its adoption by the PET industry."