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 Applikate Technologies已开发了使用多光子显微镜（Chimp）的清除组织学，这是一种新型 组织加工和成像平台可从完整病理组织提供直接到数字的图像 标本，例如活检，无需蜡嵌片，切片或扫描幻灯片。这 将该技术应用于癌症诊断将减少错误，降低成本，改善技术人员人员配备 问题，并为等待听到癌症的患者提供当天诊断。 IIB SBIR建议的目的是支持风险管理和质量的发展 制造临床设备以及临床和非临床机构所需的系统管理 FDA申请申请申请所需的验证测试。 黑猩猩在一般组织学方面具有许多优势，包括：病理学家熟悉的H＆E样图像，但 优越的图像质量，亚微米有效厚度，并且没有伪像的伪像，以便滑动制备；非 破坏性成像，可保留完整的组织，用于辅助分子分析和免疫组织化学； 快速周转，在接收组织后的几个小时内准备就绪图像；大大降低了人工成本；正确3D 预期;以及数字化图像，用于远程咨询和机器视觉。病理市场 设备和消耗品为$ 2B，对于数字病理学扫描仪，其价格为$ 1B。黑猩猩不仅准备好 作为独特而强大的竞争对手进入这些市场，但要通过降低这些市场来实际扩展 通过无缝集成到实验室工作流程并提高了数字病理的进入障碍 设备和耗材的价值，同时通过大量劳动力节省降低医院的总体成本。 该提案的具体目的是：1）执行风险分析； 2）发展和实施质量 管理系统； 3）收集有关FDA前市场提交和设施注册的数据。 这些目标的成功完成将使黑猩猩能够进入临床诊断市场， 对患者护理和健康经济学有最大的影响。