Ultra-Sensitive Point-of-Care Toxin Diagnostics

超灵敏的护理点毒素诊断

• 批准号: 8707158
• 负责人: Gregory Sommer
• 金额: $ 14.92万
• 依托单位: SANDSTONE DIAGNOSTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2015-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8707158
• 关键词: Address; Adoption; Affinity; Animal Model; Animals; Anthrax disease; Antibodies; Benchmarking; Biological Assay; Biological Markers; Biological Sciences; Bontoxilysin; Clinical; Clinical Trials; Clinics and Hospitals; Communicable Diseases; Computer software; Detection; Development; Devices; Diagnosis; Diagnostic; Enzyme-Linked Immunosorbent Assay; Exposure to; FDA approved; Feces; Funding; Goals; Health care facility; Heart Diseases; Housing; Human Resources; Immunoassay; Infection; Infectious Agent; Intellectual Property; Intoxication; Laboratories; Laboratory Research; Lead; Legal patent; Licensing; Life; Malignant Neoplasms; Marketing; Mus; National Institute of Allergy and Infectious Disease; Optics; Pathogen detection; Performance; Phase; Plastics; Preparation; Primary Health Care; Procedures; Protocols documentation; Public Health; Reagent; Research; Research Personnel; Ricin; Sampling; Shiga Toxin; Shiga-Like Toxins; Small Business Innovation Research Grant; Speed; Staphylococcal Enterotoxin B; System; Systemic disease; Technology; Testing; Toxin; Validation; Whole Blood; Work; biodefense; botulinum; design; improved; innovation; instrument; instrumentation; meetings; novel; operation; outcome forecast; pathogen; point of care; point-of-care diagnostics; programs; prototype; public health relevance; rapid detection; research clinical testing; screening; tool; validation studies

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.

描述（由申请人提供）：拟议的第一阶段SBIR项目将支持Sandstone Diagnostics，Inc.以证明用于快速检测来自临床样品的痕量毒素水平的商业即时诊断系统的可行性。意义：在疑似暴露于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充分的，并且由于从临床样品（例如全血）确认中毒所需的极端分析灵敏度，对于许多优先毒素仍然没有FDA批准的测试。创新：我们正在申请专利的系统可直接从临床样本中快速（约15分钟）和多重定量NIAID优先毒素，无需预先样品制备，从而独特地满足了这一需求。迄今为止开发的检测方法包括肉毒神经毒素、志贺样毒素、蓖麻毒素、葡萄球菌肠毒素B和炭疽。我们已经证明，该系统的检测限比现有的测试程序（例如，使用相同的亲和试剂的肉毒杆菌和ELISA协议的小鼠生物测定）低10倍-100倍。方法：我们将通过以下方式证明商业采用的可行性：（1）开发适合于在研究实验室中稳健操作的阿尔法级原型仪器，（2）开发和包装通用塑料测定盒和珠试剂盒，合作实验室将使用该平台开发和测试新的测定，以及（3）将系统和试剂部署到USDA-Albany进行独立开发、测试，和毒素测定的验证（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，而我们的团队正在为我们的靶向滋贺毒素的铅测定试剂盒寻求FDA 510（k）许可。公司名称：Sandstone Diagnostics，Inc.成立于2012年4月在利弗莫尔，CA。公司联合创始人Schaff和Sommer在桑迪亚国家实验室发明了用于即时生物防御应用的专利申请技术，包括NIAID U 01资助改进的毒素诊断系统。该公司已从Sandia获得知识产权许可，用于包括传染病在内的临床诊断应用。商业市场和客户：最终产品将作为进入传染病市场的战略切入点，因为该平台具有强大的多功能性，可进行高性能的临床测试。我们将首先将该产品作为生命科学和临床实验室的研究仪器推向市场。我们的最终目标是将仪器和耗材系列推向医院、诊所和公共卫生实验室，用于常规的床旁临床诊断。