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

细针抽吸活组织检查(FNAB)是一种在美国广泛使用的微创肿瘤取样方法。从历史上看，FNAB样本为显微镜检查提供了足够的材料；然而，分子靶向制剂(MTA)的成功开发和应用也将要求在FNAB样本中可靠地检测新的分子生物标记物。一个耐人寻味的可能性是识别信息丰富的体外生物标记物--可以从FNAB获得的活肿瘤细胞中获得的动态生物标记物。这些体外生物标记物有可能揭示单个肿瘤中信号通路的功能结构，从而产生分子图谱。我们和其他人已经成功地使用人工样本处理方法将FNAB样本用于此类研究，但这项技术的广泛应用将需要一个强大和可重复的实施平台。在这份合同建议书中，我们提出了一种创新的FNA活组织检查方法和仪器(SnapPath)，将独特地满足这一未得到满足的需求。这项提案是对PHS 2009-1(主题257)的极大响应，该提案对“保存肿瘤分子特征的活组织检查仪器和设备”表示了特别的兴趣，包括那些将“创建一个全新的诊断区域”和“实现实体肿瘤的个体化分子治疗”的设备。

Fine Needle Aspiration Biopsy (FNAB) is a minimally-invasive method for sampling human tumors that is widely used in the United States. Historically, FNAB samples have provided adequate material for microscopic examination; however, the successful development and use of molecularly targeted agents (MTAs) against cancer will also demand the robust and reliable detection of novel molecular biomarkers in FNAB samples. One intriguing possibility is the identification of informative ex vivo biomarkers- dynamic biomarkers that can be elicited from live tumor cells obtained by FNAB. These ex vivo biomarkers have the potential to reveal the functional architecture of signaling pathways in individual tumors thus producing a molecular profile. We, and others, have successfully utilized FNAB samples for such studies using manual sample processing methods, but widespread application of this technique will require a robust and reproducible platform for implementation. In this contract proposal, we present an innovative FNA biopsy approach and instrument (SnapPath¿) that will uniquely address this unmet need. This proposal is extremely responsive to PHS 2009-1 (Topic 257), which expresses particular interest in "biopsy instruments and devices that preserve molecular profiles in tumors", including those that will "create an entirely new diagnostic area" and "enable individualized molecular therapy of solid tumors."