Commercialization of a Microscale, Point-of-Use Radiosynthesis Device for the Development and Production of PET Probes

Positron Emission Tomography (PET) is a molecular imaging modality that utilizes radiolabeled molecules (probes) to target and measure biological processes. Basic scientists can use the same probes to examine microorganisms, cells, and mice as they do in patients to visualize and characterize the biology of disease, monitor its progression, and evaluate therapeutic efficacy. Although over 1,600 PET probes have been developed to help answer a variety of biological questions, only the glucose analog ([18F] FDG) is routinely used. This limitation exists because of the centralized radiopharmacy approach to PET probe production, with its complexity, high infrastructure cost, and necessity of specialized equipment and skilled personnel. A decentralized approach to PET probe development is required to give scientists the freedom to determine what probes they want to use to best solve the problems of their interest. This goal can be achieved by building a benchtop, PC-controlled, microfluidic chip-based commercial device for the on-demand production of PET probes. Phase I of this project will answer basic commercial feasibility questions about the underlying Electro-Wetting-On-Dielectric (EWOD) microfluidic chip technology, while Phase II will produce a commercial prototype of the device, complete with a PC-based control system that contains an inexpensive, disposable, probe-specific cartridge of the microfluidic chip and associated reagents. As an eventual product, a library of chips will be developed based on customer needs for different probes. Shifting to a point-of-research/point-of-care model is a transformational solution that removes the limitations imposed by the centralized model on probe production, cost, and diversity. By empowering scientists and clinicians to control the development and use of PET probes, they are able to focus on processes that they believe are most important for the environmental and biological sciences.