A rapid solution-phase immunoassay for proteomics

描述（由申请人提供）：本文描述了“EVEIA”免疫测定的开发，其具有取代用于验证低丰度生物标志物的现有技术的潜力。蛋白质检测是现代医学的核心技术，因为几乎所有疾病（包括癌症）都可以通过监测人体中的蛋白质浓度（例如PSA，BRAC-1和2）来检测。然而，新发现的低丰度生物标志物的验证（由于人类基因组计划而迅速增长的列表）是当前技术没有很好服务的领域。EVEIA将成为生物标志物验证的首选平台，主要是通过显示低丰度蛋白质的有意义测量所需的上级灵敏度，而且还通过提供更简单的测定开发和比其他“高灵敏度”测定平台更容易使用。验证竞技场的成功也将为诊断市场带来机会。低丰度蛋白质很难测量，特别是在临床相关的情况下，如血浆或唾液。这种困难导致了在研究和临床领域中关于这些蛋白质的非生产性循环。由于难以确定难以测量的蛋白质的临床相关性，因此在临床实验室中几乎不需要测量此类蛋白质的仪器。相反，由于临床需求很少，因此确定这些低丰度蛋白质的临床相关性的压力很小。不幸的是，大多数新发现的蛋白质都是低丰度的。一种仪器或测定方法，使测量这些蛋白质更容易将加快研究和加强临床医学。本申请描述了EVEIA的基本、正在进行的开发，包括与现有高灵敏度检测方法的比较。Controlled Process Technologies（CPT）组建了一支拥有80多人年实验室和仪器开发经验的团队，拥有近100篇同行评审出版物和15多项已颁发专利。该团队拥有将EVEIA检测方法应用于研究和临床实验室的专业知识。作为专门应用于癌症医疗保健，EVEIA技术有可能通过允许验证和分析可用于人类癌症的诊断、监测和基础研究的低丰度蛋白质来极大地扩展可用生物标志物的群体。CPT正在开发一种蛋白质免疫测定和仪器，预计其灵敏度比现有商业仪器高出两到三个数量级，同时保持易用性和成本效益。这种仪器将允许研究和检测人类基因组计划发现的蛋白质生物标志物，这些蛋白质生物标志物通常浓度太低，无法通过现有技术轻易检测。因此，可能被忽视的生物标志物可以普遍用于医学诊断和研究。

DESCRIPTION (provided by applicant): Described herein is the development of the "EVEIA" immunoassay that has the potential to supplant existing techniques for the validation of low-abundance biomarkers. Protein assays are a core technology of modern medicine, as nearly all diseases (including cancer) can be detected by monitoring protein concentrations in the human body (e.g. PSA, BRAC-1&2). However, the validation of newly identified low-abundance biomarkers (a rapidly growing list due to the Human Genome Project) is an area that is not well-served by current technology. EVEIA will become the platform of choice for biomarker validation mainly by displaying the superior sensitivity necessary for meaningful measurements of low-abundance proteins, but also by providing simpler assay development and being easier to use than other "high sensitivity" assay platforms. Success in the validation arena should also lead to opportunities in the diagnostics market. Low-abundance proteins are hard to measure, especially in clinically relevant contexts such as plasma or saliva. This difficulty leads to a non-productive cycle in the research and clinical arenas in regards to such proteins. Since it is difficult to determine the clinical relevance of a protein that is difficult to measure, there is little demand for instruments to measure such proteins in the clinical laboratories. Conversely, with little clinical demand, there is little pressure to determine the clinical relevance of these low-abundance proteins. Unfortunately, most new protein discoveries can be expected to be found in low abundance. An instrument or assay that would make the measurement of such proteins easier would speed research and enhance clinical medicine. This application describes the basic, ongoing development of EVEIA, including comparisons with existing high-sensitivity assays. Controlled Process Technologies (CPT) has assembled a team with over 80 person-years of laboratory and instrument development experience, with authorship of nearly one hundred peer-reviewed publications and more than 15 issued patents. This team has the expertise to bring the EVEIA assay to the point that its applications in both the research and clinical laboratory are readily apparent. As specifically applied to cancer health-care, the EVEIA technology has the potential to greatly expand the population of available biomarkers by allowing the validation and analysis of low-abundance proteins that can be used for the diagnosis, monitoring, and basic research of human cancer. CPT is developing a protein immunoassay and instrumentation that is expected to have a level of sensitivity two to three orders of magnitude better than existing commercial instruments, while maintaining ease-of-use and cost benefits. Such an instrument will allow the study and detection of protein biomarkers discovered by the Human Genome Project that are normally found in concentrations too low for easy detection by current technology. Biomarkers that might be otherwise ignored could therefore become generally available for medical diagnosis and research.