SBIR Phase II: Biosensor for Rapid Whole Blood Assays using Magnetic Labels and Giant Magnetoresistive Sensors

This Small Business Innovation Research (SBIR) Phase II project advances the general state of diagnostics research in the veterinary and security/defense markets using whole-blood assays. This Phase II project will develop (1) an automated Open Assay Development Platform for rapid assay prototyping; (2) whole blood assays for canine immunity assessment and canine thyroid test (T4); and, (3) multiplexed, canine whole blood assays. The approach uses magnetic beads to label biomolecules captured onto a receptor-patterned microchip that contains an embedded array of magnetic microsensors. The magnetic microsensors are wire-like structures that display giant magnetoresistance (GMR). When coupled with controlled fluidic force discrimination - an innovation that greatly reduces unwanted background signal - rapid identification of biomolecules with high sensitivity and specificity is achieved. A prototype system has been developed for both immunoassays and nucleic acid assays, with immunoassays (1 ng/mL) saturating in less than 10 minutes and unmodified DNA detected at 10fm in less than 20 minutes. Seahawk is responding to the clinical and financial challenges veterinarians face by developing a multi-use, multiplexed instrument and associated disposable cartridges. This technology platform offers veterinarians superior performance (faster, more accurate, easier to use) and greater profitability than existing products. Initially, the platform will include cartridges for two applications: (1) individualized immunity assessment and (2) disease diagnostics, both specifically for dogs and cats. The system provides an in-clinic, quick turnaround, cost-effective and accurate test of an animal's immune system to determine what, if any, vaccine boosters need to be administered at that time. This provides the veterinarians with three key benefits: (1) improving the quality of care - providing revaccinations only when needed and tailored to each animal; (2) generating additional or replacement revenue due to changes in revaccination protocols; and, (3) replacing annual revaccinations as the impetus for customer compliance with scheduling office visits for physical exams.