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

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力支持数字病理学。在过去的世纪中，病理学已经在组织的显微镜薄切片上进行，所述切片被染色并固定在玻璃显微镜载玻片上以供病理学家分析。这个过程是劳动密集型的，成本高，周转时间通常是一周。对于绝大多数活检程序，诊断结果在手术后几天甚至几周内都无法获得。目前用于活检样本的快速诊断和质量保证的床旁病理学技术是缓慢的、不准确的、对组织有破坏性的，并且需要多个受过训练的人员的存在，这阻止了它们被广泛使用。最近的技术进步允许物理显微镜载玻片的数字化，并实现完全数字化的病理学工作流程。然而，迄今为止，没有系统可以在成像之前通过整个漫长、费力的处理生命周期获取新鲜组织样本。 该项目将开发一个组织处理和成像平台，以便在组织切除后几分钟内实现从新鲜样本到数字图像的快速自动处理。这将提供更好的护理和患者结局，并为在病理学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第二阶段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，无需训练有素的人员现场。该项目将支持新策略的开发，以自动从具有广泛变化的表面形貌的样品中获取高质量的显微图像，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、无需手动的自动化样品处理，以提高单次分析多个样品的吞吐量。该项目将最终在验证和临床验证的集成系统。这个奖项反映了NSF的法定使命，并已被认为是值得通过评估使用基金会的智力价值和更广泛的影响审查标准的支持。

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.