SBIR Phase II: An automated digital pathology lab for rapid on-site processing and imaging of tissue biopsies

这项小企业创新研究（SBIR）二期项目的更广泛影响/商业潜力支持数字病理学。在过去的一个世纪里，病理学一直是在显微镜下薄薄的组织切片上进行的，这些组织切片被染色并安装在玻璃显微镜载玻片上供病理学家分析。这个过程是劳动密集型的，成本很高，周转时间通常是一周。对于绝大多数活检手术，诊断结果在手术后数天甚至数周内无法获得。目前用于快速诊断和质量保证活检样本的床边病理学技术速度慢、不准确、对组织有破坏性，并且需要多名训练有素的人员在场，这阻碍了它们的广泛应用。最近的技术进步使物理显微镜载玻片数字化，并实现完全数字化的病理工作流程。然而，迄今为止，没有一种系统可以在成像之前的整个漫长而费力的处理生命周期中采集新鲜的组织样本。该项目将开发一个组织处理和成像平台，以实现在组织去除后几分钟内从新鲜样品到数字图像的快速、自动化处理。这将提供更好的护理和患者的结果，并为在病理资源更有限的临床环境中提供护理提供新的机会。这个小型企业创新研究二期项目继续开发一个集成技术平台，使组织处理和数字成像的整个过程自动化，从而不需要训练有素的人员在现场。该项目将支持新策略的开发，以自动获取具有广泛不同表面地形的样品的高质量显微图像，同时提高速度和图像质量，以满足临床需求。新技术将支持并行、免提自动样品处理，以提高在一次会话中分析多个样品的吞吐量。该项目最终将对综合系统进行验证和临床验证。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/ commercial potential of this Small Business Innovation Research (SBIR) Phase II project supports digital pathology. For the past century, pathology has been performed on microscopically thin sections of tissues that are stained and mounted onto glass microscope slides for analysis by a pathologist. This process is labor-intensive, costly, and the turnaround time is typically one week. For the vast majority of biopsy procedures, the diagnostic result is not obtained for days or even weeks after the procedure. Current bedside pathology techniques for rapid diagnosis and quality assurance of biopsy samples are slow, inaccurate, destructive to the tissue, and require the presence of multiple trained personnel, which prevent them from being widely used. Recent technological advances allow digitizing of the physical microscope slides and enable a fully digital pathology workflow. However, to date no system can take a fresh tissue sample through the entire long, laborious processing lifecycle prior to imaging. This project will develop a tissue processing and imaging platform to enable fast, automated processing from the fresh sample to the digital image within minutes of tissue removal. This will provide better care and patient outcomes and enables new opportunities to provide care in clinical settings with more limited pathology resources. This Small Business Innovation Research Phase II project continues development of an integrated technology platform that automates the entire process of tissue processing and digital imaging, obviating the need for trained personnel to be on-site. This project will support the development of new strategies to automate the acquisition of high-quality microscopic images from samples with widely varying surface topographies, while simultaneously improving both speed and image quality to meet clinical needs. The new technologies will support parallel, hands-free automated sample processing to increase throughput for analysis of multiple samples in a single session. The project will culminate in verification and clinical validation of the integrated system.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.