On-Site Multiplexed GMO Detector to Facilitate Traceability

转基因（GM）作物和其他食品被广泛使用，因为它们提高了生产力，改善了营养，减少了农业化学品的使用，以及其他好处。然而，由于未知的健康风险以及许多社会经济问题，它们的使用存在争议。因此，已经出台了管制转基因生物释放的立法，并要求对食品和饲料进行全面的可追溯性。这导致美国对测试转基因性状存在的新技术的需求日益增加。这在一个为规模、速度和效率而构建的系统中是具有挑战性的。我们建议开发一种新的方法，同时检测多个转基因性状。所提出的方法结合了一个便携式生物传感器，进行多分析物测量，连同一个基于纳米技术的检测系统，提供高信号放大，在环境温度下具有良好的稳定性。该系统旨在对食品和饲料进行筛查，以确定是否存在转基因物质、转基因的类型以及含量（%），并将对产品可追溯性、“身份保护”（IP）系统和消费者健康选择产生重大影响。该系统满足了这些领域对便携式、多分析物、定量设备的快速现场或现场应用的需求，这些领域要符合要求，需要在从生产到交付的多个阶段进行严格的分析测试。这种生物传感器还将用于检测用转基因饲料喂养的动物的牛奶和肉类中的转基因蛋白，以及用于种植转基因作物的土壤中的转基因蛋白。第一阶段的具体目标是证明我们的系统同时测量两种常见的转基因玉米蛋白的可行性，通过将其性能与基于实验室的测试进行比较来验证该检测方法，并展示基于纳米技术的检测系统的优势。第一阶段计划将提供一个概念验证系统，该系统将在第二阶段开发为原型便携式系统。用于现场快速筛查转基因产品的可靠、便携、定量方法将对简化可追溯性和知识产权、确保合规性以及阻止食品和饲料行业的欺诈（未经授权的转基因）产生重大影响。转基因食品市场是一个价值数十亿美元的产业，这是一个为我们的技术创造一个利基市场的绝佳机会，它比目前的方法更具优势。EIC通过内部制造、检测试剂盒、手持式检测阅读器和仪器的销售以及多分析物免疫分析技术的外部许可，为该技术提供了商业途径。 公共卫生相关性：该项目旨在开发一种快速识别食品中转基因生物（GMOs）的改进方法。该方法将能够以便携式格式同时对多种转基因生物进行快速现场测试，并将对改善食品安全和控制转基因材料的移动产生重大影响。

DESCRIPTION (provided by applicant): Genetically modified (GM) crops and other foods are widely used because of their increased productivity, improved nutrition, reduced use of agriculture chemicals, and other benefits. Their use is controversial, however, due to the unknown health risks, as well as many socio-economic concerns. Legislations regulating the release of GM organisms (GMOs) have therefore been introduced, and full traceability for food and feed is required. This has resulted in an increasing demand in the USA for new technologies to test for the presence of GM traits. This is challenging in a system built for scale, speed and efficiency. We propose to develop a novel method for the simultaneous detection of multiple GM traits. The proposed method combines a portable biosensor that performs multianalyte measurement, together with a nanotechnology-based detection system that provides high signal amplification with good stability at ambient temperatures. The system is designed for food and feed screening to determine if GM material is present, the type of GM, and how much (%), and will have significant impact on product traceability, "Identity Preservation" (IP) systems, and consumers health choices. The system addresses the need for portable, multianalyte, quantitative devices for rapid on-site or field applications in these areas, which to be compliant, require rigorous analytical testing at multiple stages from production to delivery. The biosensor will also have use in detecting GM proteins in the milk and meat of animals fed GM feed, and in soil used to grow GM crops. The specific aims of the Phase I are to demonstrate the feasibility of our system to simultaneously measure two common GM corn proteins, validate the assay by comparing its performance to lab-based tests, and demonstrate the advantages of the nanotechnology-based detection system. The Phase I program will provide a proof-of-concept system that will be developed in Phase II into a prototype portable system. Robust, portable, quantitative methods for rapidly screening GM product onsite will have a significant impact in streamlining traceability and IP, ensuring compliance, and discouraging fraud (unauthorized GMs) in the food and feed industry. The GM food market is a multi-billion dollar industry, and there is an excellent opportunity to create a niche for our technology, which has advantages over current methods. EIC has a commercial path for this technology through in-house manufacturing, sale of assays, hand- held assay readers and instruments, and out-licensing of our multianalyte immunoassay technology. PUBLIC HEALTH RELEVANCE: This project seeks to develop an improved method for rapidly identifying genetically modified organisms (GMOs) in food. The method will enable rapid onsite testing for multiple GMOs at the same time in a portable format, and will have significant impact on improving food safety and controlling the movement of GM material.