Administrative Core

行政核心

• 批准号: 10715494
• 负责人: Wilbur A Lam
• 金额: $ 20.6万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-18 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10715494
• 关键词: Acceleration; Adoption; Authorization documentation; Beds; Biomedical Engineering; COVID-19; COVID-19 diagnostic; COVID-19 pandemic; Cellular Phone; Charge; Child health care; Clinical; Clinical Research; Collaborations; Communication; Communities; Companions; Complex; Consultations; Country; Coupled; Data; Dedications; Development; Diagnostic; Disease; Doctor of Philosophy; Ecosystem; Electronics; Engineering; Ensure; Equilibrium; Evaluation; Fostering; Funding; Head; Healthcare; Home; Hospitals; Human; Infrastructure; Institution; International; Knowledge; Laboratories; Leadership; Learning; Medical; Medical Technology; Microfluidics; Mission; Monkeypox; Nanotechnology; Nature; Needs Assessment; Patients; Pediatric Hospitals; Point of Care Technology; Positioning Attribute; Process; Protocols documentation; Public Health; RADx; Readiness; Role; Services; Side; Site; Societies; Structure; Swab; System; Technology; Technology Assessment; Testing; Translating; Translations; Underserved Population; United States National Institutes of Health; Validation; authority; biobank; clinical application; clinical infrastructure; clinical practice; commercialization; design; diagnostic platform; diagnostic technologies; experience; health equity; implementation design; improved; innovation; manufacture; manufacturing scale-up; meetings; microchip; microsystems; mobile application; new pandemic; novel; organizational structure; pediatrician; portability; pre-clinical; programs; prototype; response; sensor; smartphone application; translational diagnostics; usability; user centered design; validation studies

Administrative Core PROJECT SUMMARY/ABSTRACT Since the advent of POC diagnostics several decades ago, one class of novel medical technologies that has shown promise for POC applications is microsystems diagnostics, that is, microchip-enabled tests ranging from microelectromechanical systems (MEMs)-based sensors, microfluidics, to smartphone-based systems. Notable for their small size, low power requirements, and high sensitivity, microsystems provide portability that is vital for POC testing. Since 2018, the Atlanta Center for Microsystems Engineered POC Technologies (ACME POCT) has assisted inventors who have developed microsystems-based POC technologies in defining their specific clinical needs, conducting clinical validation, and refining their technology, with the objective of accelerating the path to translation and clinical adoption. The ACME POCT uniquely leverages Atlanta’s nationally top-ranked clinical programs at Emory’s hospitals and Children’s Healthcare of Atlanta (CHOA), one of the nation’s largest pediatric hospital systems, as well the internationally acclaimed microsystems expertise at Georgia Tech, which includes the Institute for Electronics and Nanotechnology (IEN). The PIs of the ACME POCT uniquely balance the engineering and clinical sides of the Center and comprise Wilbur Lam, MD, PhD, a pediatrician at Emory/CHOA and a Georgia Tech bioengineer with a personal track record in microfluidics and POC diagnostic development and commercialization; Oliver Brand, PhD, a renowned microsystems engineer and head of Georgia Tech’s IEN; and Greg Martin, MD, MSc, an internationally known clinical pulmonologist/intensivist at Emory with system-level clinical research leadership experience. Over the last 4 years, the ACME POCT has applied a “disease inclusive” approach by fostering the development of 22 microsystems-based POC technologies for all clinical applications. As the COVID-19 pandemic emerged and the NIH established the Rapid Acceleration of Diagnostics (RADx) initiative to assess, validate, and scale-up production of POC COVID-19 diagnostics for the entire country, the ACME POCT served as the national Test Verification Core. As such, the ACME POCT established itself as a center of excellence in diagnostics evaluation by developing an efficient yet comprehensive test verification strategy by progressively assessing technologies in various laboratory then clinical settings, with parallel assessments of usability and regulatory strategy. Importantly, our Atlanta bio-innovation ecosystem has also flourished, including the launch of an Emory-based center that is dedicated to developing POC tests for achieving health equity among underserved populations, and a program that develops clinical mobile apps, often as companion technologies for POC diagnostics. With our distinctive role in RADx combined with our uniquely enhanced expertise, ecosystem and infrastructures, the ACME POCT is now especially well positioned to apply our lessons learned from RADx towards assisting microsystems POC diagnostics for all clinical applications via a “hands on” and pro-active approach.

行政核心项目概要/摘要 自从几十年前POC诊断的出现以来，一类新的医疗技术， 微系统诊断是POC应用前景看好的一个领域，即微芯片测试，范围从 从基于微机电系统（MEMS）的传感器、微流体到基于智能手机的系统。显著 由于微型系统体积小、功耗要求低、灵敏度高，因此它具有可移植性，这对于 POC测试自2018年以来，亚特兰大微系统工程POC技术中心（ACME POCT） 帮助开发了基于微系统的POC技术的发明者定义他们的 具体的临床需求，进行临床验证，并完善其技术，目的是 加快转化和临床应用的步伐。ACME POCT独特地利用了亚特兰大的 埃默里医院和亚特兰大儿童保健中心（CHOA）的全国顶级临床项目， 美国最大的儿科医院系统，以及国际知名的微系统专业知识 在格鲁吉亚理工学院，其中包括电子和纳米技术研究所（IEN）。ACME的PI POCT独特地平衡了中心的工程和临床方面，包括Wilbur Lam，MD， 博士，埃默里/CHOA的儿科医生和格鲁吉亚理工学院的生物工程师， 微流体和POC诊断开发和商业化;奥利弗品牌，博士，一个著名的 微系统工程师和格鲁吉亚理工学院的IEN负责人;和格雷格马丁，医学博士，理学硕士，国际 Emory知名临床肺病学家/重症监护医师，具有系统级临床研究领导经验。 在过去的4年里，ACME POCT采用了“疾病包容”的方法， 为所有临床应用开发22种基于微系统的POC技术。随着COVID-19 大流行出现，NIH建立了快速诊断加速（RADx）倡议， 验证并扩大全国POC COVID-19诊断试剂的生产，ACME POCT 作为国家测试验证中心。因此，ACME POCT确立了自己作为 通过制定有效而全面的测试验证策略， 在各种实验室和临床环境中逐步评估技术，并进行平行评估 可用性和监管策略。重要的是，我们的亚特兰大生物创新生态系统也蓬勃发展， 包括推出一个位于埃默里的中心，致力于开发POC测试，以实现健康 在服务不足的人群中实现公平，以及开发临床移动的应用程序的计划，通常作为配套产品 POC诊断技术。凭借我们在RADx中的独特作用， 专业知识，生态系统和基础设施，ACME POCT现在特别适合应用于 我们从RADx中学到的经验教训有助于微系统POC诊断用于所有临床应用 通过“动手”和积极主动的方法。