Automated molecular diagnosis on fine needle aspirates (FNA)

癌细胞的分子分析对于建立诊断和指导是必不可少的。 治疗。传统的组织活检在提供有关组织结构的关键信息的同时，也与 发病率高，费用高，因此不能像临床所希望的那样频繁地进行。一个 切割核心活检枪的替代方法是细针抽吸(FNAs)，这可以通过 最小限度的干预，并允许更少的侵入性和/或对小病变的重复采样。然而， 使用常规细胞学和免疫组织化学方法对FNA标本进行检查仍然具有挑战性。至 为了解决这些障碍，Aikii BiosSystems寻求实现FNA样本的当天诊断检查 使用专有的“快速”分析和自动图像细胞仪。Aikii技术的关键组件 是我们专有的细胞周期方法(FAST)，它建立并扩展了以前的检测功能(4- 通道多路复用)到20-40多个生物标志物；它与我们的图像细胞仪相结合，这是一台独立的 诊断平台能够在&lt；2小时内实现癌细胞自动分类。在初始基础上构建 开发和临床前验证，在目标1中，我们将在&gt；15癌症中验证快速抗体探针 标记物，将样本处理与Aikii的细胞仪系统集成，并使用 设备。在目标2中，我们将评估用于快速、当天分析的集成技术的好处 临床标本，特别是淋巴瘤FNA标本(n=40)用FAST-Linker修饰抗体染色 探测器。当Aikii的系统可靠地检测到淋巴瘤并对其进行分类时，第一阶段将被视为成功 细胞与黄金标准的比较。第一阶段的成功完成将为第二阶段奠定基础 应用于临床测试和制造细胞仪系统和商用墨盒 多发性癌症。该平台具有转变细胞诊断和病理工作流的潜力 通过快速、当天的微创FNAs分析；其强大的药效学分析 标志物具有开发新的、具有临床意义的生物标志物的潜力，这些生物标志物可以用于 推进药品开发。

Molecular analyses of cancer cells are essential in establishing diagnoses and guiding available treatments. Conventional tissue biopsies, while providing key information on tissue architecture, are associated with morbidity and high cost and therefore are not performed as frequently as would be clinically desirable. An alternative to cutting core biopsy guns are fine needle aspirations (FNAs), which can be performed with minimal intervention and allow for less invasive and/or repeated sampling from small lesions. However, workup of FNA specimens remains challenging using conventional cytology and immunohistochemistry. To address these barriers, Aikili Biosystems seeks to enable same-day diagnostic workup of FNA samples using a proprietary “FAST” assay and automated image cytometer. A key component of Aikili's technology is our proprietary cell cycling method (FAST), which builds upon and expands previous assay capabilities (4- channel multiplexing) to over 20-40 biomarkers; it is coupled with our image cytometer, a stand-alone diagnostic platform capable of automated cancer cell classification in <2 hours. Building upon initial development and pre-clinical validation, in Aim 1, we will validate FAST antibody probes in >15 cancer markers, integrate sample processing with Aikili's cytometry system and analyze associated images using the device. In Aim 2, we will evaluate the benefit of the integrated technology for rapid, same-day analysis of clinical samples, specifically lymphoma FNA samples (n = 40) stained with FAST-linker modified antibody probes. Phase I will be deemed successful when Aikili's system reliably detects and classifies lymphoma cells compared to gold standards. Successful completion of Phase I will lay the foundation for a Phase II application for clinical testing and manufacture of cytometry systems and commercial cartridges for multiple cancers. This platform has potential to transform cellular diagnostics and pathology workflows through rapid, same-day analyses of minimally invasive FNAs; its robust analyses of pharmacodynamic markers has potential to enable development of new, clinically meaningful biomarkers that can be used to advance drug development.