Positron Emission Tomography (PET) is a molecular imaging modality that utilizes radiolabeled molecules (?probes?) to target and measure biological processes. Researchers 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. Over 4000+ PET probes have been developed to help answer a variety of biological questions, but only the glucose analog [18F]FDG is routinely used for molecular imaging diagnostics in patient care. There is still an unmet need to develop additional probes which can annotate key aspects of disease, including those in which the diagnostics share common targets with drugs, to truly establish it as a key technology for realizing improved treatment and monitoring in personalized medicine. The clinical translation of next generation PET probes is in part hampered by the high cost and complexity of the infrastructure, specialized equipment, and skilled personnel required for synthesis. Overcoming these hindrances to PET probe development, optimization, and routine production is necessary to facilitate the entry of novel PET probes into clinical research and trials, and to select those with value as companion biomarkers. A decentralized approach to PET radiotracer development is required to give scientists and clinicians the freedom to determine the 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-based commercial device for the on-demand production of PET probes. Phase I of this project answered basic commercial feasibility questions about the underlying microfluidic chip technology. Phase II addressed technological challenges inherent in creating a commercial microscale radiosynthesizer so the synthesis of diverse PET probes for brain imaging can be performed in a simple and convenient manner at a low cost. This Phase IIB proposal aims to bring the prototype to a commercial design and synthesize novel neuro-probes with full quality control validation to prepare its use for the clinical manufacturing of PET probes under cGMP guidelines. Shifting to a point-of-research/point-of-care model is a transformational solution that removes the limitations imposed by the traditional model of PET probe production. To facilitate a paradigm shift in the enablement of novel PET probes for the clinical community, a fundamental change in production ideology and infrastructure re-imagining is required; an affordable, benchtop, self-shielded, compact, easy-to-use, microfluidic-based radiosynthesis platform for the on-demand production of PET probes will provide expanded access to PET for researchers and clinicians in academia and industry.

Public Health Relevance

Novel molecular imaging modalities to measure biochemical and cellular events in patients are needed in personalized medicine to transform the care of patients with brain disorders. The goal of this proposal is to develop an affordable, compact, microfluidic-based device to produce PET probes, thereby enabling scientists and clinicians to image diverse biological systems by eliminating barriers of cost and complexity that currently limit probe availability and diversity. The scientific yield from this may lead to improved therapies for the pathophysiology of brain disorders, significantly affecting public health.

National Institute of Health (NIH)
National Institute of Mental Health (NIMH)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
Application #
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Grabb, Margaret C
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Sofie Biosciences, Inc.
Culver City
United States
Zip Code
Wang, Jia; Chao, Philip H; Hanet, Sebastian et al. (2017) Performing multi-step chemical reactions in microliter-sized droplets by leveraging a simple passive transport mechanism. Lab Chip 17:4342-4355
Keng, Pei Yuin; van Dam, R Michael (2015) Digital Microfluidics: A New Paradigm for Radiochemistry. Mol Imaging 14:13-14