SBIR TOPIC 257, INSTRUMENTS AND DEVICES THAT PRESERVE MOLECULAR PROFILES IN TUMO

活检在个性化癌症治疗的发展和监测中起着至关重要的作用。当前 内脏肿瘤的活检方法在保留肿瘤的分子轮廓方面无效，因为 在手术过程中和之后发生的快速的酶反应。我们的方法是开发一种 自动活组织检查装置，(1)通过快速保存 生物标本，(2)通过自动化获取和保存肿瘤的步骤来确保过程的一致性 样品，以及(3)通过允许用户选择低温或化学来提供生物标志物评估的灵活性 保护。该提案描述了一种利用可互换墨盒的设备概念，该墨盒 使用低温或化学固定剂自动存储和保存活检样本。在这 项目，我们将设计和制造一个原型装置，并通过测试来评估其防腐效果 它用大鼠和SCID小鼠建立胰腺癌细胞系模型。我们计划使用免疫组织化学， 病理学、蛋白质组学和基因组学，用于评估该设备保存分子图谱的情况 肿瘤组织。成功完成后，这一阶段工作的结果将证明 验证了我们方法的可行性，并为进一步开发临床使用的设备提供了设计输入。

Biopsies play an essential role in developing and monitoring of personalized cancer treatments. Current biopsy methods for visceral tumors are ineffective at preserving the molecular profile of the tumor due to the rapid enzymatic reactions that take place during and after the procedure. Our approach is to develop an automated biopsy device that (1) Limits molecular profile degradation by rapidly preserving the biopspecimen, (2) ensures process consistency by automating the steps to obtain and preserve the tumor sample, and (3) provides biomarker assessment flexibility by allowing users to choose cryogenic or chemical preservation. This proposal describes a device concept that utilizes interchangeable cartridges that automatically store and preserve the biopsy sample using either cryogenic or chemical fixative. In this project, we will design and fabricate a prototype device and evaluate its preservation effectiveness by testing it on Rats and SCID mice with a pancreatic cancer cell line model. We plan to use immunohistochemistry, pathology, proteomics, and genomics for evaluating how well the device preserves the molecular profile of the tumor tissue. When successfully completed, the findings of this Phase-1 work will demonstrate the feasibility of our approach and provide the Design Inputs for further developing the device for clinical use.