Commercial Readiness for Direct-to-Digital Pathology

直接数字病理学的商业准备

• 批准号: 10678409
• 负责人: Michael John Levene
• 金额: $ 22.49万
• 依托单位: APPLIKATE TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10678409
• 关键词: 3-Dimensional; Address; Adult; Anxiety; Authorization documentation; Biopsy; Client; Clinical; Consultations; Contracts; Country; Data; Development; Devices; Diagnosis; Diagnostic; Diagnostic Errors; Documentation; Engineering; Equipment; Equipment and Supplies; Evaluation; Failure; Feedback; Funding; General Practitioners; Health Sciences; Hearing; Hematoxylin and Eosin Staining Method; Histology; Hospitals; Hour; Human; Image; Imaging Device; Immunohistochemistry; Instruction; Laboratories; Malignant Neoplasms; Manufacturer; Marketing; Molecular Analysis; Morphologic artifacts; Noise; Output; Pathologic; Pathologist; Pathology; Patient Care; Patients; Phase; Preparation; Privatization; Procedures; Prostatic Neoplasms; Qualifying; Readiness; Recording of previous events; Records; Remote Consultation; Research; Research Contracts; Research Design; Resolution; Risk; Risk Management; Savings; Scanning; Signal Transduction; Slice; Slide; Small Business Innovation Research Grant; Specimen; System; Technology; Testing; Thick; Tissue imaging; Tissues; Translating; United States National Institutes of Health; Validation; Wait Time; Waxes; Work; Workload; authority; breast cancer diagnosis; cancer diagnosis; cancer subtypes; clinical development; clinical diagnostics; cost; design; digital imaging; digital pathology; digital platform; experience; falls; health economics; imaging platform; improved; interest; machine vision; malignant breast neoplasm; manufacture; medical schools; multiphoton microscopy; novel; preservation; pressure; prospective; response; stem; submicron; tissue processing; verification and validation; whole slide imaging

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.

项目摘要 Replikate Technologies开发了一种新型的多光子显微镜组织学（CHiMP）， 提供来自完整病理组织的直接数字化图像的组织处理和成像平台 标本，如活组织检查，而不需要蜡包埋，切片，或扫描载玻片。的 这项技术在癌症诊断中的应用将减少错误，降低成本，改善技术人员的配备， 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。 本阶段IIb SBIR提案的目的是支持风险管理和质量的发展 生产临床器械以及临床和非临床器械所需的系统管理 FDA上市前批准申请所需的验证测试。 CHiMP对于一般组织学具有许多优点，包括：病理学家熟悉的H& E样图像，但 上级图像质量，亚微米有效厚度，无载玻片制备中常见的伪影; 保留完整组织用于辅助分子分析和免疫组织化学的破坏性成像; 快速周转，图像在收到组织后几小时内准备就绪;大大降低了劳动力成本;真正的3D 前瞻性;以及用于远程咨询和机器视觉的数字化图像。病理学市场 设备和消耗品是20亿美元，数字病理扫描仪是10亿美元。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，但实际上通过降低 通过无缝集成到实验室工作流程中， 设备和用品的价值，同时通过显著节省劳动力降低医院的总体成本。 本提案的具体目标是：1）进行风险分析; 2）制定并实施质量管理体系， 管理系统; 3）收集FDA上市前提交和设施注册的数据。 这些目标的成功实现将使CHiMP能够进入临床诊断市场， 对患者护理和卫生经济学产生最大影响。