TRACE-ABILITY INC — Department of Health and Human Services SBIR Phase II: 102

Description

Project SummaryPositron Emission TomographyPETis regarded as a standard of care in the management of multiple types of cancerAvailability of this procedure relies on a steady supply of a radioactive contrast agentFFluorodeoxy d glucoseFDGDue to the inherent short half lifeminmultiple batches of FDG are typically produced at multiple sites on daily basisQuality ControlQCof FDG remains the most laborskilland risk intensive part of the production processReliance of QC on manual operationsubjectivity and untraceable recordslimits the number of FDG batches that may be produced per day per facilitywhich in turn limits availability of PET imaging to cancer patientsTrace Ability has taken an unconventional approach to QC automationcalled Tracer QCwhich relies on optical measurements by a microplate reader for most of the QC testsThe innovation is in the disposable kit that enables multiple tests from a single sample on a single platform composed of a microplate reader and automated pipettorMost of the QC tests have been already enabled by Trace Ability relying on NCI Phase I SBIR and other fundingRadiochemical purity and chemical identity QC tests will be enabled during Phase II by integration of an HPLC component into the plate reader pipettor system in a seamless way which allows the user to use a single sample to obtain a single report onQC parametersThe integrated solution will then be validated for use in clinical FDG productionThe second component of the Phase II project will focus on setting up reliable production of disposable Tracer QC kits at commercial scaleUpon achievement of the above aimsTrace Ability will be in position to offer FDG manufacturers a fully automated QC solution that has been completely validatedThis is critical since production of shortlived PET tracers has extremely low tolerance for failureOptimized production processes will yield Tracer QC kits that are not only optimized for reliabilitybut also for costmaximizing the commercial potential of the Tracer QC business that relies on recurring kit revenues from the growing install baseFinallyhaving an FDG QC solution with on board HPLC enables expansion of Tracer QC to any other PET tracers without further revisions of the stationary hardwaremaking it a true scalable platformThe impact in the field of Oncology will be manifested in increased availability of FDG scans and facilitation of new tracer developmentUpon completion of the project Trace Ability plans to use the new platform to develop QC methods for more PET tracers such asFFDOPAbrain tumorsFFLTgeneral oncological tracerCCholineprostate tumorsGaDOTATOCendocrine tumors