Commercial Readiness for Direct-to-Digital Pathology

项目摘要 Applikate Technologies开发了一种新的多光子显微镜(CHAMP)清除组织学 组织处理和成像平台，提供完整病理组织的直接数字图像 标本，如活组织检查，不需要蜡包埋、切片或扫描载玻片。这个 将这项技术应用于癌症诊断将减少差错，降低成本，改善技术人员配置 问题，并为等待听到他们是否患有癌症的患者提供当天的诊断。 此IIb阶段SBIR提案的目的是支持风险管理和质量的发展 临床设备制造所需的系统管理，以及临床和非临床设备 FDA上市前批准申请所需的验证测试。 黑猩猩在一般组织学上有许多优势，包括：病理医生熟悉的类似H&E的图像，但 卓越的图像质量，亚微米级的有效厚度，没有幻灯片准备常见的伪影； 为辅助分子分析和免疫组织化学保存完整组织的破坏性成像； 快速周转，在收到组织后几个小时内即可准备好图像；大大降低了劳动力成本；真正的3D 以及用于远程会诊和机器视觉的数字化图像。病理学的市场 设备和消耗品是20亿美元，数字病理扫描仪是10亿美元。黑猩猩不仅准备好 作为一个独特而强大的竞争对手进入这些市场，但实际上是通过降低 通过无缝集成到实验室工作流程并提高 设备和用品的价值，同时仍然通过大量节省劳动力来降低医院的总体成本。 本建议的具体目标是：1)进行风险分析；2)开发和实施质量 管理系统；3)为FDA上市前提交和设施注册收集数据。 这些目标的成功实现将使黑猩猩能够进入临床诊断市场。 对病人护理和医疗经济有最大的影响。

Project Summary Applikate Technologies has developed Clearing Histology with Multiphoton Microscopy (CHiMP), a novel tissue processing and imaging platform that provides direct-to-digital images from intact pathology tissue specimens, such as biopsies, without the need for wax embedding, slicing, or scanning of slides. The application of this technology to cancer diagnosis will reduce errors, lower costs, ameliorate technician staffing issues, and provide same-day diagnosis for patients waiting to hear if they have cancer. The aim of this Phase IIb SBIR proposal is to support the development of risk management and quality systems management required for the manufacture of clinical devices, as well as the clinical and non-clinical validation testing required for an application for premarket approval by the FDA. CHiMP has many advantages for general histology, including: H&E-like images familiar to pathologists but with superior image quality, sub-micron effective thickness, and without artifacts common to slide preparation; non- destructive imaging that preserves intact tissue for ancillary molecular analysis and immunohistochemistry; rapid turnaround, with images ready within a few hours of receiving tissue; greatly reduced labor costs; true 3D prospective; and digitized images for remote consultation and machine vision. The market for pathology equipment and consumables is $2B, and for digital pathology scanners it is $1B. CHiMP is poised to not only enter these markets as a unique and strong competitor, but to actually expand upon them by lowering the barrier to entry for digital pathology through seamless integration into the laboratory workflow and raising the value of equipment and supplies while still lowering overall costs to hospitals through significant labor savings. The specific aims of this proposal are to: 1) Perform risk analysis; 2)Develop and implement a Quality Management System; 3) Collect data for an FDA premarket submission and facility registration. Successful completion of these aims will enable CHiMP to enter the clinical diagnostic market, where it can have maximum impact on patient care and health economics.