Trace-Ability, a Los Angeles-based radiopharmaceutical company, announced that the FDA has approved the first use of its solution, Tracer-QC, for release testing Ammonia N 13 Injection at Massachusetts General Hospital (MGH) in Boston.
Tracer-QC automates the PET tracer release testing process, which the company says is known for its complexity.
“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,” Arkadij Elizarov, CEO of Trace-Ability, said in a prepared statement. “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.”
“Our goal is to help the industry transition to a more streamlined PET drug production and quality control workflow," Daniel Yokell, associate director for radiopharmacy and regulatory affairs at the Gordon Center for Medical Imaging at MGH, said in the same statement. “In turn we can hopefully expand patient access to these critical diagnostic procedures outside of large academic medical centers.”