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

活检在开发和监测个性化癌症治疗方面发挥着重要作用。电流 内脏肿瘤的活组织检查方法在保留肿瘤的分子谱方面是无效的， 在手术过程中和手术后发生的快速酶促反应。我们的方法是开发一个 自动活检装置，其（1）通过快速保存 生物标本，（2）通过自动化步骤确保过程的一致性，以获得和保存肿瘤 样品，以及（3）通过允许用户选择低温或化学方法来提供生物标志物评估的灵活性 保存。该提案描述了一种利用可互换药筒的装置概念， 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，我们将设计和制造原型装置，并通过测试评估其保存效果 它对大鼠和SCID小鼠的胰腺癌细胞系模型。我们计划用免疫组织化学， 病理学、蛋白质组学和基因组学，用于评价器械如何保留以下分子特征： 肿瘤组织成功完成后，第一阶段工作的结果将证明 我们的方法的可行性，并提供设计输入，以进一步开发用于临床使用的器械。

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.