Ultra-Sensitive Point-of-Care Toxin Diagnostics

描述(由申请人提供)：拟议的第一阶段SBIR项目将支持Sandstone Diagnostics，Inc.证明商业护理点诊断系统的可行性，以快速检测临床样本中的微量毒素水平。意义：在疑似接触NIAID优先毒素的病例中，早期临床检测中毒对于改善预后至关重要。现有的临床诊断方法是不够的，而且由于从临床样本(例如全血)确认中毒所需的极端分析灵敏度，许多优先毒素仍然没有FDA批准的检测。创新：我们正在申请专利的系统独一无二地满足了这一需求，直接从临床样本中快速(约15分钟)和多路定量检测NIAID优先毒素，无需预先准备样本。到目前为止开发的检测方法包括肉毒杆菌神经毒素、志贺样毒素、蓖麻毒素、葡萄球菌肠毒素B和炭疽杆菌。我们已经证明，该系统的检测下限比现有的检测程序低10倍-100倍(例如，使用相同亲和试剂的肉毒杆菌小鼠生物检测和ELISA法)。方法：我们将通过以下方式论证商业采用的可行性：(1)开发适合于研究实验室强大操作的Alpha级原型仪器；(2)开发和包装通用塑料试剂盒和珠状试剂盒，供合作实验室使用该平台开发和测试新的检测方法；以及(3)将系统和试剂部署到美国农业部-奥尔巴尼，用于毒素分析的独立开发、测试和验证(第二阶段)。该系统将在第二阶段作为仅供研究使用的产品推出，同时我们的团队正在争取FDA 510(K)批准我们针对志贺毒素的铅分析试剂盒。公司：砂岩诊断公司于2012年4月在加利福尼亚州利弗莫尔成立。公司联合创始人沙夫和索默在桑迪亚国家实验室发明了这项正在申请专利的技术，用于护理点生物防御应用，包括为改进毒素诊断系统提供NIAID U01资金。该公司已经从Sandia获得了用于包括传染病在内的临床诊断应用的知识产权许可。商业市场和客户：鉴于该平台在强大、高性能临床测试方面的多功能性，最终产品将成为进入传染病市场的战略切入点。我们最初将把该产品作为生命科学和临床实验室的研究仪器进行销售。我们的最终目标是将该仪器和系列耗材推向医院、诊所和公共卫生实验室，用于常规的临床点临床诊断。

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 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.