SBIR Phase I: Hybrid Deformability and Fluorescence Cytometer for Biomarker Development and Validation

SBIR 第一阶段：用于生物标志物开发和验证的混合变形能力和荧光细胞仪

• 批准号: 1315895
• 负责人: Daniel Gossett
• 金额: $ 15万
• 依托单位: CytoVale, Inc
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1315895&HistoricalAwards=false
• 关键词: SBIR; Phase; Hybrid; Deformability; Fluorescence

This Small Business Innovation Research (SBIR) Phase I project will address the challenge of integrating two powerful single-cell analysis tools with the aim of developing and validating new biomarkers for malignancy. The deformability of invasive cells has long been hypothesized to confer their ability to migrate through tight tissue barriers and form metastases. Recently, this idea has been supported by mechanical measurements of cells either isolated from or directly in biological fluid specimens. This convergence of ideas from both biological and physical sciences represents a mechanical biomarker, and tools to be employed clinically to assay these properties are rapidly being developed. Cytovale?s technology measures cell deformability at a throughput of several thousand cells per second, comparable to the ubiquitous flow cytometer, which allows immediate measurement of cells directly in biological fluids. This technology has a demonstrated utility: highly sensitive detection of malignancy in cellularly heterogeneous clinical pleural effusions. Its integration with fluorescence in this project will provide a transformational research and clinical tool, well-aligned with the critical aims of improving patient care and reducing costs through automation, early detection of disease, and use of quantitative, novel biomarkers.The broader impact/commercial potential of this project is realized by appreciating the applicability of the technology across research and clinical settings. Even without integration with fluorescence (flow) cytometry the technology has demonstrated its utility as a sensitive detector of malignancy in clinical specimens, specifically, pleural effusions. However, cell mechanics is an attractive biomarker for invasiveness, and is likely conserved throughout cells found in many biological fluids, including urine and fine needle aspirates. The proposed activity will further enhance the technology?s diagnostic accuracy. The instruments developed by Cytovale will be placed in clinical cytology labs to complement gold standard cytological methods, performing high sensitivity screens of biological fluids and eliminating unnecessary, invasive, and costly follow-up procedures. The hybrid instrument will also be an especially powerful tool for exploring connections between cell mechanics and traditional markers, which greatly extends the number of research laboratories which would benefit from this enabling technology.

这个小企业创新研究（SBIR）一期项目将解决整合两种强大的单细胞分析工具的挑战，目的是开发和验证新的恶性肿瘤生物标志物。侵袭性细胞的可变形性长期以来一直被假设赋予它们通过紧密组织屏障迁移并形成转移的能力。最近，这一观点得到了从生物流体标本中分离或直接提取的细胞的机械测量的支持。这种生物科学和物理科学思想的融合代表了一种机械生物标志物，用于临床分析这些特性的工具正在迅速开发。Cytovale吗?S技术以每秒数千个细胞的吞吐量测量细胞的变形能力，可与无处不在的流式细胞仪相媲美，流式细胞仪可以直接测量生物液体中的细胞。该技术已被证明具有实用价值：在细胞异质性临床胸腔积液中高度敏感地检测恶性肿瘤。在这个项目中，它与荧光的结合将提供一种变革性的研究和临床工具，与通过自动化、疾病早期检测和使用定量的新型生物标志物来改善患者护理和降低成本的关键目标完全一致。通过评估该技术在研究和临床环境中的适用性，实现了该项目更广泛的影响/商业潜力。即使没有与荧光（流式）细胞术结合，该技术也证明了其在临床标本，特别是胸腔积液中作为恶性肿瘤敏感检测器的实用性。然而，细胞力学是一种有吸引力的侵入性生物标志物，并且可能在许多生物液体（包括尿液和细针抽吸液）中发现的细胞中都是保守的。拟议的活动会否进一步提升科技？S诊断准确性。Cytovale开发的仪器将用于临床细胞学实验室，以补充金标准细胞学方法，对生物液体进行高灵敏度筛选，并消除不必要的、侵入性的和昂贵的后续程序。混合仪器也将是一个特别强大的工具，用于探索细胞力学和传统标记之间的联系，这极大地扩展了研究实验室的数量，这些实验室将从这项使能技术中受益。