Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME POCT)

ACME POCT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技术的发明者定义其特定的 临床需求，进行临床验证，并完善他们的技术，目的是加快 翻译和临床采用的途径。ACME POCT独特地利用了亚特兰大全国排名第一的 埃默里医院和亚特兰大儿童保健中心（CHOA）的临床项目， 儿科医院系统，以及格鲁吉亚技术， 包括电子和纳米技术研究所（IEN）。ACME POCT的PI唯一地平衡 该中心的工程和临床方面，包括威尔伯林，医学博士，博士，儿科医生在 Emory/CHOA和一位格鲁吉亚理工学院的生物工程师，在微流体和POC诊断方面有着个人记录 奥利弗品牌，博士，著名的微系统工程师和负责人， 格鲁吉亚理工学院的IEN; Greg Martin，MD，MSc，国际知名的临床肺病学家/重症监护医师， Emory，具有系统级临床研究领导经验。在过去的四年里，ACME POCT已经 通过促进22个基于微系统的POC的开发， 所有临床应用的技术。随着COVID-19大流行的出现和NIH建立了快速 加速诊断（RADx）计划，以评估，验证和扩大POC COVID-19的生产 ACME POCT作为全国测试验证核心，为整个国家提供诊断服务。因此， ACME POCT通过开发一种高效而又 通过逐步评估各实验室的技术， 临床环境，同时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，包括推出一个以埃默里为基础的中心，致力于 开发POC测试，以实现服务不足人群的健康公平，并制定一项计划， 临床移动的应用程序，通常作为POC诊断的配套技术。凭借我们在RADx中的独特角色 结合我们独特的增强型专业知识、生态系统和基础设施，ACME POCT现在 特别适合将我们从RADx中学到的经验教训应用于协助微系统POC 通过“动手”和主动的方法对所有临床应用进行诊断。

Overall ACME POCT 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.