AIR Option 1: Technology Translation: KS-Detect: A complete "sample-in, answer-out" solution to the diagnosis of Kaposi's Sarcoma

AIR 选项 1：技术翻译：KS-Detect：卡波西肉瘤诊断的完整“样本输入、应答输出”解决方案

• 批准号: 1343411
• 负责人: David Erickson
• 金额: $ 15万
• 依托单位: Cornell University
• 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: 2013-09-15 至 2015-02-28
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1343411&HistoricalAwards=false
• 关键词: AIR; Option; Technology; Translation; KS

This PFI: AIR Technology Translation project focuses on translating our KS-Detect system which will represent the first complete ?sample-in-answer-out? solution for the diagnosis of Kaposi's sarcoma (KS) in limited resource settings. The translated KS-Detect system combines our (1) ?lab-on-a-syringe? technology for biopsy extraction and sample processing, (2) solar-thermal PCR (polymerase chain reaction) for extremely low-power nucleic acid amplification, and (3) a nanoparticle based colorimetric smartphone assay for the quantification of the results. The system is designed to be used by a field nurse and addresses a number of challenges with low resource setting diagnosis of Kaposi?s sarcoma including: the ability to take and process a biopsy sample in the field, providing at least a 10-fold increase in the number of diagnostic reactions that can be performed on a single battery charge by using sunlight to drive the thermal cycling process, and elimination of the reliance on specialized instrumentation enabling the system to be fixed in the field by the operator. The project accomplishes its objectives by constructing a complete prototype resulting in pre-clinical optimization which is a critical evaluation stage prior to clinical implementation. The partnership engages experts in limited resource setting diagnostics to provide guidance in the field requirements as they pertain to the potential to translate the KS-Detect system along a path that may result in a competitive commercial reality. The potential economic impact is expected to be significant in the long term and the project will contribute to the U.S. competitiveness in biomedical diagnostics. The societal impact, long term, will be better diagnostics of Kaposi?s sarcoma. Kaposi's sarcoma is the leading cancer in men and the second leading cancer in women in sub-Saharan Africa. KS is difficult to distinguish from other angioproliferative diseases, particularly in Africa where access to trained pathologists is limited to few hospitals and immunohistochemistry is practically non-existent. Multiple studies have shown that PCR based nucleic acid identification of Kaposi?s sarcoma herpesvirus (KSHV) in skin biopsies represents the best method of performing an unambiguous diagnosis in the absence of immunohistochemistry. In addition to the research activities proposed here, we will develop a series of social media tools to facilitate world-wide sharing of recent scientific and technological advances in limited resource setting diagnostics. Services like Facebook and Twitter are now the dominant method by which information is disseminated across the world, but their adoption by the scientific community has been painfully slow. Here we will use these tools to establish a virtual community of doctors, scientists, engineers, technologists, and field workers interested in limited resource setting diagnostics. New technologies, news articles, results of clinical studies, and other information of interest will be disseminated through these tools to this community.

这个 PFI：AIR 技术翻译项目的重点是翻译我们的 KS-Detect 系统，该系统将代表第一个完整的“样本输入答案输出”。在资源有限的情况下诊断卡波西肉瘤 (KS) 的解决方案。 翻译后的 KS-Detect 系统结合了我们的 (1) “注射器实验室”？用于活检提取和样品处理的技术，(2) 用于极低功率核酸扩增的光热 PCR（聚合酶链式反应），以及 (3) 用于量化结果的基于纳米粒子的比色智能手机测定。 该系统设计供现场护士使用，解决了卡波西肉瘤低资源环境诊断的许多挑战，包括：在现场采集和处理活检样本的能力，提供至少 10 倍的提高通过使用阳光驱动热循环过程，可以在单次电池充电时执行诊断反应的数量，并且消除对专用仪器的依赖，使操作员能够将系统固定在现场。 该项目通过构建完整的原型来实现其目标，从而实现临床前优化，这是临床实施之前的关键评估阶段。 该合作伙伴关系聘请了有限资源设置诊断方面的专家，以提供现场要求方面的指导，因为这些要求涉及将 KS-Detect 系统沿着可能导致竞争性商业现实的路径转化的潜力。 从长远来看，潜在的经济影响预计将是巨大的，该项目将有助于提高美国在生物医学诊断领域的竞争力。 从长远来看，社会影响将是更好地诊断卡波西肉瘤。卡波西肉瘤是撒哈拉以南非洲地区男性的主要癌症和女性的第二大癌症。 KS 很难与其他血管增殖性疾病区分开来，特别是在非洲，那里只有少数几家医院能够接触到训练有素的病理学家，而且几乎不存在免疫组织化学。 多项研究表明，基于 PCR 的皮肤活检中卡波西肉瘤疱疹病毒 (KSHV) 核酸鉴定是在缺乏免疫组织化学的情况下进行明确诊断的最佳方法。 除了这里提出的研究活动之外，我们还将开发一系列社交媒体工具，以促进在全球范围内分享有限资源设置诊断方面的最新科学技术进展。 Facebook 和 Twitter 等服务现在是在世界范围内传播信息的主要方式，但科学界对它们的采用却进展缓慢。 在这里，我们将使用这些工具建立一个由对有限资源设置诊断感兴趣的医生、科学家、工程师、技术人员和现场工作人员组成的虚拟社区。 新技术、新闻文章、临床研究结果和其他感兴趣的信息将通过这些工具传播到这个社区。