The proposed Phase I SBIR project will support Sandstone Diagnostics, Inc. to demonstrate feasibility of a commercial point-of-care diagnostic system for rapid detection of trace toxin levels from clinical samples. Significance: Early clinica detection of intoxication is critical for improved prognosis in cases of suspected exposure to NIAID priority toxins. Existing clinical diagnostic approaches are inadequate, and there remain no FDA-cleared tests for many priority toxins due to the extreme analytical sensitivities required for confirmation of intoxication from clinical samples (e.g. whole blood). Innovation: Our patent-pending system uniquely addresses this need with rapid (~15 minute) and multiplexed quantitation of NIAID priority toxins directly from clinical samples with no upfront sample preparation. Assays developed to date include Botulinum Neurotoxin, Shiga-like toxin, Ricin, Staphylococcal Enterotoxin B, and Anthrax. We have proven that the system achieves 10x - 100x lower limits of detection than existing testing procedures (e.g. the mouse bioassay for Botulinum and ELISA protocols using identical affinity reagents.) Approach: We will demonstrate feasibility toward commercial adoption by: (1) developing an Alpha-level prototype instrument suitable for robust operation in a research laboratory, (2) developing and packaging universal plastic assay cartridges and bead reagent kits with which partnering laboratories will develop and test new assays using the platform, and (3) deploying the system and reagents to the USDA-Albany for independent development, testing, and validation of toxin assays (Phase II). The system will be launched as a research-use only product in Phase II while our team pursues FDA 510(k) clearance for our lead assay kit targeting Shiga toxin. Company: Sandstone Diagnostics, Inc. was founded in April 2012 in Livermore, CA. Company co-founders Schaff and Sommer invented the patent-pending technology at Sandia National Laboratories for point-of-care biodefense applications, including NIAID U01 funding for an improved toxin diagnostics system. The company has licensed the intellectual property from Sandia for clinical diagnostic applications including infectious disease. Commercial Market and Customers: The final product will serve as a strategic entry point to the infectious disease market given the platform's versatility for robust, high-performance clinical testing. We will initially market the product as research instrument for life science and clinical laboratories. Our ultimate goal is to market the instrument and line of consumables to hospitals, clinics, and public health laboratories for routine point-of-care clinical diagnostics.
The proposed product will enable ultra-sensitive quantitation of NIAID priority biotoxins directly from unprocessed clinical samples at the point-of-care. The versatile instrumentation also has broad applicability for diagnosis of other systemic diseases and conditions including infectious pathogens, heart disease, and cancer.