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

这项小型企业创新研究（SBIR）二期项目利用全血检测技术推进了兽医和安全/国防市场诊断研究的总体状况。该二期项目将开发(1)用于快速分析原型的自动化开放式分析开发平台；(2)犬免疫全血检测和甲状腺T4检测；(3)多路犬全血分析。该方法使用磁珠来标记捕获到的生物分子，这些生物分子被捕获到包含嵌入式磁微传感器阵列的受体图案微芯片上。磁性微传感器是显示巨磁阻（GMR）的线状结构。当与受控流体力识别相结合时-一种大大减少不必要背景信号的创新-实现了高灵敏度和特异性的生物分子快速识别。已经开发了一个用于免疫分析和核酸分析的原型系统，免疫分析（1 ng/mL）在不到10分钟内饱和，在10fm下不到20分钟检测到未修饰的DNA。海鹰通过开发一种多用途、多路复用的仪器和相关的一次性药盒来应对兽医面临的临床和财务挑战。该技术平台为兽医提供了比现有产品更优越的性能（更快、更准确、更容易使用）和更高的盈利能力。最初，该平台将包括两种应用的试剂盒：(1)个体化免疫评估和(2)疾病诊断，专门针对狗和猫。该系统提供了一种临床、快速周转、具有成本效益和准确的动物免疫系统测试，以确定当时需要施用何种疫苗增强剂（如果有的话）。这为兽医提供了三个关键的好处：(1)提高护理质量-仅在需要时为每只动物提供重新接种疫苗；(2)由于重新接种方案的改变而产生额外或替代收入；(3)取代每年重新接种疫苗作为客户遵守安排办公室体检的动力。

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.