This Small Business Innovation Research Phase I project will develop a personal radiation biodosimetry platform for point-of-care assessment of radiation exposure. This utilizes a novel sensor array platform that will enable label-free biomarker quantification in a low-cost, active disposable format. This technology leverages the power and economies of scale of integrated circuits, built up over the previous fifty years for high-performance computation and imaging, for low-cost, bioelectronic applications. Thin-film bulk acoustic resonators (FBARs) are incorporated directly with silicon integrated circuits to form a dense biosensor array. Integration with a custom microchip enables parallel measurement of dozens of sensors in a few square millimeters. Combined with antibody immobilization, this enables multiplex protein assays in real time through a simple digital interface. Phase I of this effort will demonstrate a sensitive bioelectronic assay for the established radiation exposure marker gamma-H2A.X to assess feasibility of the technology for biodosimetry applications. This effort includes the development of a lysate-based gamma-H2A.X immunosorbent assay, adaptation of this assay to the sensor platform, and demonstration of the integrated biodosimetry device.
The broader impact/commercial potential of this project is the disruptive improvement of existing radiation biodosimetry solutions. Current strategies for minimally-invasive biodosimetry rely on the establishment of centralized testing centers with high-throughput assay processing. Samples must be collected and transported to a testing center, with transportation networks often compromised alongside a radiation release event. A point-of-care biodosimetry platform would allow on-site dose quantitation for appropriate medical triage and emergency management. This is a critical and unmet need for the preparation and response to a nuclear release event. As a commercial product, the device would be purchased for pre-deployment to areas at risk for nuclear release and radiation exposure, including urban centers, nuclear reactor sites, hospitals, and local clinics. Potential customers include federal, state, and municipal authorities, commercial nuclear reactor operators, hospitals, and medical clinics. A successful product implementation will extend the reach of current biodosimetry test networks outward from central laboratories directly to emergency response sites. In the long term, the underlying technology employed here will lay the foundation for a host of multiplexed point-of-care applications, with clear clinical and commercial opportunities in infectious disease, cancer diagnostics, autoimmune disease monitoring, trauma response, and in-the-field medical testing.
This Small Business Innovation Research (SBIR) Phase I project, entitled "Personal radiation biodosimetry using thin-film bulk acoustic resonators," targeted the development of a personal radiation biodosimetry platform for point-of-care assessment of radiation exposure. Bialanx is developing an entirely new approach to radiation biodosimetry based on the integration of a novel semiconductor sensor platform and established radiation biomarkers, which together bring quantitative, multiplex biomarker quantification to a hand-held form factor. The introduction of a point-of-care radiation biodosimetry device would constitute a disruptive improvement over existing solutions, extending the reach of current test networks outward from central laboratories directly to nuclear reactor sites, large urban centers, hospitals, and local medical clinics. The SBIR Phase I effort focused primarily on assay design, minimization of required sample preparation and sample volume, and hardware process development for assay integration. At the conclusion of the Phase I project, Bialanx has successfully demonstrated a sensitive bench-top biodosimetry immunoassay that reports radiation dose from minimally processed samples. The immunoassay has been validated with multiple sample types. As importantly, the test requires a very small volume of lysed whole blood, making it compatible with finger-stick blood collection and obviating additional sample preparation hardware. Significant progress has also been made toward adaptation of the sensor platform technology for use in aqueous applications, and Bialanx is well positioned to integrate these parts to demonstrate an integrated electronic assay platform for quantification of biodosimetry biomarkers. These are critical demonstrations of the bench-top assay that support further development and investigation. This additional effort will realize commercial proof-of-concept for point-of-care radiation biodosimetry, which continues to be an important and critically underserved application.
