Commercial Readiness for Direct-to-Digital Pathology

直接数字病理学的商业准备

• 批准号: 11000919
• 负责人: Michael John Levene
• 金额: $ 46.61万
• 依托单位: APPLIKATE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-01-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/11000919
• 关键词: Commercial; Readiness; Direct; Digital; Pathology

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.

项目概要 Applikate Technologies 开发了多光子显微镜透明组织学 (CHiMP)，这是一种新颖的 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，例如活检，无需蜡包埋、切片或扫描载玻片。这 该技术在癌症诊断中的应用将减少错误，降低成本，改善技术人员配备 问题，并为等待听诊的患者是否患有癌症提供当天诊断。 IIb SBIR 提案的目的是支持风险管理和质量的发展 临床设备制造以及临床和非临床所需的系统管理 FDA 上市前批准申请所需的验证测试。 CHiMP 对于普通组织学具有许多优势，包括： 病理学家熟悉的类似 H&E 的图像，但 卓越的图像质量、亚微米有效厚度，并且没有载玻片制备中常见的伪影；非 破坏性成像，保留完整组织用于辅助分子分析和免疫组织化学； 周转速度快，在收到组织后几个小时内即可准备好图像；大大降低了人工成本；真3D 预期;以及用于远程咨询和机器视觉的数字化图像。病理学市场 设备和消耗品为 $2B，数字病理扫描仪为 $1B。 CHiMP 不仅准备 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成本来扩展这些市场 通过无缝集成到实验室工作流程并提高数字病理学的进入门槛 设备和用品的价值，同时通过大量节省劳动力来降低医院的总体成本。 该提案的具体目标是： 1) 进行风险分析； 2）制定并实施质量 管理体系； 3) 收集 FDA 上市前提交和设施注册的数据。 成功完成这些目标将使 CHiMP 能够进入临床诊断市场，在那里它可以 对患者护理和卫生经济学产生最大影响。