Technology Core

摘要： 全球护理点(POC)测试市场预计将以每年12%的速度增长，到2030年将超过900亿美元。驱动因素 市场增长包括新出现的疾病威胁、不断增加的自我检测需求、成功的市场塑造 干预措施，低收入和中等收入国家对基本诊断的需求不断增加，以及 卫生保健权力下放。现在，POC每年要进行10多亿次新冠肺炎测试， 大流行检测反应表明：新一代高性能、负担得起的分子检测可以 制造、分发并快速适应新目标；广泛的用户群可以准确地在家中执行 检测；检测结果可以在需要时进行快速治疗。POCTRN网络对此作出了重大贡献 成功。尽管RADx取得了成功，COVID的PoC测试也迅速扩大，但仍存在一些重大障碍 仍然需要实现POC测试的潜力，特别是在癌症的早期检测方面。技术的使命 公平癌症护理点技术创新和转化中心(CITEC)的核心是 加入POCTRN，专门支持和加速高优先级PoC技术的开发和转换 旨在为服务不足的人群进行癌症筛查和早期检测。技术核心(TC)的首要目标 是确定和支持新的有价值的项目，以开发用于癌症筛查或早期癌症的POC技术 通过早期临床测试从原型检测。与传播核心合作，传播委员会将进行 评估以确定癌症筛查和早期发现的高优先级未满足的临床需求，并随后 发布共识PoC技术需求声明。CITEC将发布定向募集资金，以解决 这些需求。TC将支持专门为服务不足的社区设计的技术项目，包括 旨在应对与癌症健康差距和低资源环境(例如农村)相关的挑战和障碍 设置、基础设施有限的设置)。TC的第二个目标是协助受支持的PoC技术开发人员 完善他们的临床需求说明，包括目标测试规范，并完善和评估技术性能， 其技术的可用性和可制造性，目标是加快向翻译和临床过渡的道路 领养。技术委员会将创建CITEC核心技术实验室，拥有独特和全面的技术资源，以 支持POC成像技术、POC分子传感器和机器的设计、制造和快速优化 适合移动平台的基于学习的图像分析策略。翻译委员会的第三个目标是帮助翻译 临床验证和商业化前景看好的原型。TC将与临床核心密切合作，以确定 为临床评估做好准备的技术，并支持在相关临床环境中向评估过渡。技术委员会 将与POC测试开发人员合作，加快开发商业原型并成功开发的努力 商业化战略，利用德克萨斯医疗中心和巴西的资源。通过这些目标，TC 将与CITEC的其他核心合作，建立并支持POC技术的强大管道，以实现公平的癌症筛查 以及及早发现。

Abstract: The global market for point‐of‐care (POC) tests is projected to grow 12% annually, exceeding US$90B by 2030. Drivers of market growth include emerging disease threats, increasing demand for self‐testing, successful market shaping interventions, increasing demand for essential diagnostics in low‐ and middle‐income countries (LMICs), and a trend for health‐care decentralization. More than a billion COVID‐19 tests are now performed annually at the POC, and the pandemic testing response demonstrated that: a new generation of high performance, affordable molecular tests can be manufactured, distributed, and rapidly adapted for new targets; a broad segment of users can accurately perform home testing; and test results can enable rapid treatment when needed. The POCTRN network contributed significantly to these successes. Despite the success of RADx and the rapid scale of POC testing for COVID, a number of significant barriers still remain to achieve the potential of POC testing, especially for the early detection of cancer. The mission of The Technology Core of The Center for Innovation and Translation of Point‐of‐Care Technologies for Equitable Cancer Care (CITEC) is to join POCTRN in supporting and accelerating the development and translation of high priority POC technologies specifically designed for cancer screening and early detection for under‐served populations. The first aim of the Technology Core (TC) is to identify and support new meritorious projects to develop POC technologies for cancer screening or early cancer detection from prototype through early clinical testing. In collaboration with the Dissemination Core, the TC will conduct assessments to identify high priority unmet clinical needs for cancer screening and early detection, and, subsequently, publish consensus POC Technology Needs Statements. CITEC will issue targeted solicitations offering funding to address these needs. The TC will support technology projects specifically designed for underserved communities, including those designed to address challenges and barriers associated with cancer health disparities and low‐resource settings (e.g., rural settings, settings with limited infrastructure). The second aim of the TC is to assist supported POC technology developers to refine their clinical needs statement, including target test specifications, and refine and assess technical performance, usability, and manufacturability of their technology, with the objective of accelerating the path to translation and clinical adoption. The TC will create a CITEC Core Technology Laboratory with unique and comprehensive technical resources to support the design, fabrication and rapid optimization of POC imaging technologies, POC molecular sensors, and machine learning based image analysis strategies appropriate for mobile platforms. The third aim of the TC is to help translate promising prototypes to clinical validation and commercialization. The TC will work closely with the Clinical Core to identify technologies ready for clinical evaluation and to support the transition to evaluation in relevant clinical settings. The TC will work with POC test developers to accelerate efforts to develop commercial prototypes and to develop successful commercialization strategies, leveraging resources in the Texas Medical Center and in Brazil. Through these aims, the TC will work with other CITEC cores to build and support a robust pipeline of POC technologies for equitable cancer screening and early detection.