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

细针穿刺活检（FNAB）是一种微创的人类肿瘤取样方法，在美国被广泛使用。从历史上看，FNAB样品为显微镜检查提供了足够的材料；然而，分子靶向药物（mta）的成功开发和使用还需要在FNAB样品中检测出强大可靠的新型分子生物标志物。一个有趣的可能性是鉴定信息丰富的体外生物标志物-动态生物标志物，可以从FNAB获得的活肿瘤细胞中提取。这些体外生物标志物有可能揭示单个肿瘤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利用人工样本处理方法利用FNAB样本进行此类研究，但该技术的广泛应用将需要一个强大且可重复的平台来实现。在这份合同提案中，我们提出了一种创新的FNA活检方法和仪器（SnapPath¿），将独特地解决这一未满足的需求。该提案非常符合PHS 2009-1 （Topic 257）的要求，PHS 2009-1表达了对“保存肿瘤分子谱的活检仪器和设备”的特别兴趣，包括那些将“创造一个全新的诊断领域”和“实现实体肿瘤的个体化分子治疗”的仪器和设备。

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."