Breast core-needle diagnostics in LMICs via millifluidics and direct-to-digital imaging: development and validation in Ghana

摘要 乳腺癌在全球范围内是一个越来越大的挑战，因为它在2009年底成为最普遍的恶性肿瘤。 2020.目前，70%以上的癌症死亡发生在低收入和中等收入国家（LMIC）。 组织学对许多癌症的诊断和疾病管理至关重要，尤其是乳腺癌， 目前使用的技术已经有100多年的历史。市场力量、技术 光学的进步和护理策略的创新为颠覆性创新打开了大门， 大大降低了成本和时间，并提高了可访问性，同时提供了等同的甚至上级的结果。 我们建议通过将两个已经发挥作用且互补的领域结合起来，为该领域的发展做出贡献 技术：1）组织毫流方法（在PI Seibel的实验室开发）用于手动空芯针活检 处理;和2）快速，低成本，直接数字化无载玻片成像解决方案（在PI Levenson的实验室开发）。 我们的目标是实现一个上下文适当的，自动化的工具，可以捕获诊断质量 对高质量乳腺癌诊断和分期至关重要的芯针活检的组织病理学图像， 程序的时间。其他项目目标包括实施创新的快速免疫荧光 近实时治疗指导的方法;以及开发用于患者分类甚至本地的AI工具 诊断支持，后者在Mahmood博士（BWH）的指导下，他是多类AI算法的领导者。 该项目成功的关键是在加纳库马西的地方实施和临床评价， Addai博士是和平与爱医院（成立于2002年）的顾问乳房外科医生和首席执行官。 她的小组将严格评估性能、可用性以及与服务环境的兼容性， 中心医院和远程卫星诊所;临床验证研究最终将至少包括 根据IRB批准的方案招募了数百名患者。更多的指导将由博士。 Dan米尔纳，美国临床病理学会（ASCP）的CMO，他在以下方面拥有丰富的经验： 全球健康为重点的倡议，以及我们的合作病理学家谁熟悉的问题， 与LMIC设置有关。反馈将为第二代自动化仪器的设计提供信息， 在这个项目结束时交付。

ABSTRACT Breast cancer is an increasing challenge globally as it became the most prevalent malignancy at the end of 2020. More than 70% of all cancer mortality now occurs in low- and middle-income countries (LMICs). Histology, critical to the diagnosis and disease management for many cancers notably including breast cancer, is currently performed using techniques that are more than 100 years old. Market forces, technological advances in optics, and innovation in care strategies are opening the door for disruptive innovation that could massively reduce costs and time and improve accessibility while provide equivalent or even superior results. We propose to contribute to the field's evolution by combining two already functioning and complementary technologies: 1) a tissue millifluidics approach (developed in PI Seibel's lab) for hands-off core needle biopsy handling; and 2) a rapid, low-cost, direct-to-digital slide-free imaging solution (developed in PI Levenson's lab). The goal is to implement a context-appropriate, automated instrument that can capture diagnostic-quality histopathology images from core-needle biopsies vital to high-quality breast-cancer diagnosis and staging, at time of procedure. Additional project goals include implementation of innovative rapid immunofluorescence methods for near-real-time therapy guidance; and development of AI tools for patient triage or even local diagnostic support, the latter under the direction of Dr. Mahmood (BWH), a leader in multiclass AI algorithms. Key to success of this project is local implementation and clinical evaluation in Kumasi, Ghana, under the direction of Dr. Addai, consultant breast surgeon and CEO of Peace and Love Hospitals (established in 2002). Her group will critically assess performance, usability, and compatibility with the service environment in both a central hospital and a remote satellite clinic; clinical validation studies will eventually encompass at least several hundred patients recruited under IRB-approved protocols. Additional guidance will be provided by Dr. Dan Milner, CMO of the American Society for Clinical Pathology (ASCP), who has extensive experience in global-health-focused initiatives, as well as by our collaborating pathologists who are familiar with issues relevant to LMIC settings. Feedback will inform the design of the second-generation automated instruments to be delivered near the end of this project.