A DNA-based Barcode System to Prevent Drug Counterfeiting

描述（由申请人提供）：近年来，伪造处方药的情况迅速增长。据世界卫生组织估计，假冒伪劣产品的成本每年超过400亿美元。假冒药品对消费者来说是危险的，不仅因为它们可能含有危险成分，而且因为它们延迟了患者需要的关键治疗。药品假冒不仅给药品生产商和经销商造成巨大的收入损失，而且还损害了品牌和消费者关系。由于制药公司的渠道尚未显示出改善的迹象，从防止假冒中获得的收入将直接有助于制药公司的利润。由于巨大的市场潜力和重大的公共卫生效益，已经开发了许多技术，试图解决这个日益关键的问题。虽然射频识别（RFID）技术被认为是最有希望实现这一目标的技术，但由于各种原因，它尚未被广泛部署到医药供应链管理中。医药行业分析师的广泛市场分析表明，尽管市场对遏制和降低药品假冒水平的愿望强烈，但它需要一种易于使用和实施，难以调和，需要比当前RFID技术更小的投资，检测准确，对药品没有影响的解决方案，并且对隐私问题和机密商业交易数据的所有权敏感。高恩普特生物公司(HTB)正在开发一种创新的基于DNA的条形码技术（EZCode），不仅可以满足制药行业的特定需求，还可以满足许多其他商业行业防止假冒的需求。EZCode技术生产了一种一次性或多次使用的微型DNA标签（EZTag），可以很容易地与托盘，箱子或瓶子/单元级别的运输药物相关联。在检测时，标签被插入手持设备（EZReader），这不仅会验证标签，但产生一个明确的代码表示标签上的信息。消费者、药品经销商和药店将使用EZReader来验证标签，从而验证药品。在本阶段的提案中，我们将开发EZCode技术的原型，包括原型EZTag和原型EZTag检测系统。如果成功，EZCode技术将为公共卫生带来重大利益。 公共卫生相关性：近年来，伪造处方药的现象十分普遍。据世界卫生组织估计，假冒伪劣产品的成本每年超过400亿美元。假冒药品对消费者来说是危险的，不仅因为它们可能含有危险成分，而且因为它们延迟了患者需要的关键治疗。药品造假也给药品制造商造成了巨大的收入损失。医药供应链市场正在寻找一种易于使用和实施的解决方案，难以调和，需要比当前RFID技术更小的投资，检测准确，对药物没有影响，对隐私问题和机密业务交易数据的所有权敏感。EZCode系统解决了这些未得到满足的需求，并有可能大大减少假冒药品的数量，改善公众健康。1

DESCRIPTION (provided by applicant): Counterfeiting of prescription medication has grown rapidly in recent years. The World Health Organization estimates that the cost of counterfeiting is more than $40 billion a year. Counterfeited drugs are dangerous to consumers not only because they might contain dangerous ingredients but also because they delay critical treatments that patients need. Drug counterfeiting not only results in huge revenue loss to drug manufacturers and distributers, but also damages the brand and consumer relationship. As the pharmaceutical companies' pipelines have yet to show sign of improvement, revenue recouped from preventing counterfeiting will contribute directly to the bottom lines of pharmaceutical companies. Because of the huge market potential and significant public health benefit, many technologies have been developed trying to address this increasingly critical issue. Although the radio frequency identification (RFID) technology has been seen as the most promising technology to achieve the goal, it has yet to be widely deployed to pharmaceutical supply chain management for various reasons. Extensive market analysis by analysts in the pharmaceutical industry indicates that although the market has strong desire to contain and reduce the level of drug counterfeiting, it demands a solution that are easy to use and implement, hard to temper with, requires smaller investment than the current RFID technology, accurate at detection, has no effect on drugs, and sensitive to privacy concerns and to ownership of confidential business transaction data. High Throughput Biology Inc. (HTB) is developing an innovative DNA-based barcode technology (EZCode) to address not only the specific needs of the pharmaceutical industry, but also the needs in many other commercial industries to prevent counterfeiting. The EZCode technology produces a single-use or multi-use miniature DNA-based tag (EZTag) that can be easily associated with shipped drugs at the pallet, case, or bottle/unit level. At detection time, a tag is inserted into a handheld device (EZReader), which will not only authenticate the tag but produce an unambiguous code representing the information on the tag. The consumers, drug distributers, and pharmacies will use the EZReader to authenticate the tags therefore verify the drugs. In this phase of the proposal, we will develop a prototype of the EZCode technology, including a prototype EZTag and a prototype EZTag detection system. If successful, the EZCode technology will bring significant benefit to public health. PUBLIC HEALTH RELEVANCE: Counterfeiting of prescription medication has become wide-spread in recent years. The World Health Organization estimates that the cost of counterfeiting is more than $40 billion a year. Counterfeited drugs are dangerous to consumers not only because they might contain dangerous ingredients but also because they delay critical treatments that patients need. Drug counterfeiting also results in huge revenue loss to drug manufacturers. The pharmaceutical supply chain market is looking for a solution that are easy to use and implement, hard to temper with, requires smaller investment than the current RFID technology, accurate at detection, has no effect on drugs, and sensitive to privacy concerns and to ownership of confidential business transaction data. The EZCode system addresses those unmet needs and has the potential to significantly reduce the amount of drug counterfeiting and improve public health. 1