Ultra-Sensitive Point-of-Care Toxin Diagnostics

DESCRIPTION (provided by applicant): 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 ofNIAID 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