SBIR-STTR Award

This Small Business Innovation Research (SBIR) Phase I project is focused on the development of a protein-based biosensor for immunity assessments in companion animals. The objective is to develop a prototype of a disposable biochip/fluidics cartridge and associated reader for a panel of canine diseases. A sandwich immunoassay on a biochip will be developed to measure antibody titer levels associated with canine diseases. In contrast to existing biochips, the fluorescent labels typically used will be replaced by magnetic nanobeads. These nanonbeads can be detected individually using an array of magnetic field sensors embedded in the biochip. The anticipated result of this project will be a biosensor that is simpler, more sensitive and less expensive than existing fluorescent-based biosensors. Moreover, the commercial biosensor may be readily adapted to detect biowarfare agents. There is growing evidence that the standard protocol of routine revaccinations of canines is often unnecessary because the animal still has protective immunity levels. Not only do over-vaccination create additional costs for dog owners, health risks exist with every vaccine - ranging from life-threatening conditions to conditions that degrade quality of life. The ability to use a biosensor to perform low-cost, real-time immunity assessments address the current over-vaccination problem by allowing veterinarians to provide tailored disease protection protocols. Immunity assessments are currently not part of the standard vaccination protocol because current immunity assessments solutions are either: 1) too costly, 2) take too long, 3) do not test a full vaccine panel, or 4) provide results that are difficult to interpret. This solution combines all of the key features necessary to be part of a veterinarian's immunity assessment protocol

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