A DNA-based Barcode System to Prevent Drug Counterfeiting

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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