SBIR Phase I: Development of a Device for Early Detection of Uterine Cancer Cells at the Point-of-Care

SBIR 第一阶段：开发用于床旁早期检测子宫癌细胞的设备

• 批准号: 1746384
• 负责人: Ramonita Díaz-Ayala
• 金额: $ 22.5万
• 依托单位: Bidea
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1746384&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Device; Early

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project, if successful, will be the implementation of an effective point-of-care (POC) test that will not only impact the lives of patients, but can reduce the costs to hospitals, health insurances companies, and government agencies. According to the National Institutes of Health, cancer cost the U.S. an estimated $219 billion in 2007, including $130 billion for lost productivity and $89 billion in direct medical costs. The proposed screening technology is expected to help gynecologists in hospitals or in private practice to provide a complete diagnosis in less time, reducing the number of visits and the endometrial cancer incidence through an early detection, especially in women over 50 years old. This would benefit the medical insurance by lowering the cost per patient with this type of cancer. If successful, the proposed non-label/real-time cancer diagnostic device will contribute to new scientific findings and engineering aspects in bio-sensing technology. The resulting device will also provide a non-invasive, fast, and accurate method to detect cancer for preclinical diagnosis. In addition, the research based on this technology will improve a range of equivalent studies that use similar systems and biological indicators. The proposed project is aimed to develop a POC technology for the sensitive detection of telomerase as a cancer measurable indicator in real-time. Telomerase is a distinctive enzyme whose presence in cells or tissues is used for screening, early cancer detection, prognosis and/or monitoring a residual cancer disease. The proposed technology is based on the detection of telomerase in cancer cells through the measuring of an in-situ elongation process of an immobilized label-free single strand DNA probe by means of sensitive electrochemical events occurring at the conductive gold microchip surface. For the development of this new sensing microchip device the team will use commercially available products. Silicon wafers have been used as substrate with gold as electrodes due to their reliability but these materials are expensive and the fabrication is labor intensive. Therefore, important diagnostic device parameters will be studied after incorporation of bare bio-sensing strips. Phase I of this project, is aimed at demonstrating the feasibility of the proposed technology as well as testing the reliability and robustness of the microchip biosensor using uterine cancer samples.

如果成功，该小企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力将是实施有效的护理点 (POC) 测试，这不仅会影响患者的生活，而且可以降低医院、健康保险公司和政府机构的成本。据美国国立卫生研究院统计，2007 年癌症给美国造成了 2190 亿美元的损失，其中包括 1300 亿美元的生产力损失和 890 亿美元的直接医疗费用。拟议的筛查技术有望帮助医院或私人诊所的妇科医生在更短的时间内提供完整的诊断，通过早期检测减少就诊次数和子宫内膜癌的发病率，特别是对于 50 岁以上的女性。这将降低每位患有此类癌症的患者的费用，从而使医疗保险受益。如果成功，拟议的非标签/实时癌症诊断设备将有助于生物传感技术领域的新科学发现和工程方面。由此产生的设备还将提供一种非侵入性、快速且准确的方法来检测癌症以进行临床前诊断。此外，基于该技术的研究将改进一系列使用类似系统和生物指标的等效研究。拟议项目旨在开发一种 POC 技术，用于实时灵敏地检测端粒酶作为癌症可测量指标。端粒酶是一种独特的酶，其存在于细胞或组织中，用于筛查、早期癌症检测、预后和/或监测残留癌症疾病。所提出的技术基于通过导电金微芯片表面发生的敏感电化学事件测量固定化无标记单链DNA探针的原位延伸过程来检测癌细胞中的端粒酶。为了开发这种新型传感微芯片设备，该团队将使用商用产品。由于其可靠性，硅片已被用作基底，金作为电极，但这些材料价格昂贵，且制造过程需要大量劳动力。因此，在结合裸露的生物传感条后，将研究重要的诊断设备参数。该项目的第一阶段旨在证明所提出技术的可行性，并使用子宫癌样本测试微芯片生物传感器的可靠性和稳健性。