Submillimeter Technology for Molecular Biomarkers

用于分子生物标志物的亚毫米技术

• 批准号: 6882990
• 负责人: ANJAL C SHARMA
• 金额: $ 13.8万
• 依托单位: LYNNTECH, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-01-01 至 2006-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6882990
• 关键词: asthma; bioengineering /biomedical engineering; biomarker; biomedical equipment development; breath tests; bronchus disorder; clinical biomedical equipment; diagnosis design /evaluation; interstitial lung diseases; miniature biomedical equipment; molecular /cellular imaging; nanotechnology; noninvasive diagnosis; patient care management; patient care planning; respiratory disorder diagnosis; respiratory imaging /visualization; spectrometry

DESCRIPTION (provided by applicant): The ultimate objective of this research project will be the development and commercialization of a low cost, reliable and widely available point-of-care testing device for screening, diagnosis and management of disease in human patients. The proposed technique, submillimeter photoacoustic spectrometry of human breath, will initially be used to identify and quantify molecular bio-marker profiles that simulate the discrimination of metabolic products in patients with symptoms for a small number of selected diseases including asthma, bronchiectasis, interstitial lung disease. A major advantage of the proposed technique is that it is non-invasive, and highly selective based on state-specific detection of molecular finger print profiles characteristic of the specific diseases. This will be achieved by application of recently availability of intense and highly monochromatic backward-wave oscillators spectroscopic sources (10-100 mWatt power, 3x10/-8 cm/-1 linewidth). Such capabilities will be incorporated in our device design, and exploited to identify and measure the characteristic frequency signatures of selected molecular markers including nitric oxide, carbon monoxide, and ammonia with ppb or better sensitivity necessary for effective medical application. The proposed work will demonstrate the feasibility and practicability of the proposed technique for the diagnosis and management of the selected diseases. We propose to carry out the following tasks during this Phase I STTR: 1) Assemble initial bench scale assembly and setup. 2) Establish procedures for calibration and verification of molecular markers. 3) Develop procedures for preparation and delivery of specified concentrations of marker molecules in sample chamber of device. 4) Demonstrate ppb detection levels for single specific biomarker molecules. 5) Demonstrate simultaneous ppb detection of simulant mixtures of different bio-markers. 6) Conceptually design small footprint Phase II prototype. Commercialization: The proposed studies will prepare the way for the subsequent simplification and miniaturization of the initial instrumental design in Phases II and III. During this development, we will work with medical device manufacturers to assist in manufacturing, FDA approval, and marketing. Further market segments for commercialization will be explored for its wider and more general medical use.

描述（由申请人提供）： 该研究项目的最终目标是开发和商业化低成本，可靠且可广泛可用的护理点测试设备，用于筛查，诊断和管理人类患者的疾病。提出的技术，即人类呼吸的亚损声光谱法，最初将用于识别和量化分子生物标志物概况，以模拟症状的代谢产物的歧视，以造成少数选定疾病的症状患者，包括哮喘，支气管疾病，间质肺肺疾病。提出的技术的一个主要优点是它是非侵入性的，并且基于特定于特定疾病的分子指纹特征的状态特异性检测而高度选择性。这将通过应用最近的高度且高度单色的振荡器光谱源（10-100 mwatt功率，3x10/-8 cm/-1线路）来实现。此类功能将纳入我们的设备设计中，并利用以识别和测量所选分子标记物的特征性频率特征，包括一氧化氮，一氧化碳和具有PPB或更高灵敏度的氨或有效医疗应用所需的灵敏度。拟议的工作将证明所提出的技术在选定疾病的诊断和管理中的可行性和实用性。我们建议在此阶段I STTR中执行以下任务：1）组装初始基准尺度组件和设置。 2）建立校准和验证分子标记的程序。 3）制定程序，以制备和递送指定浓度的标记分子在设备的样品腔中。 4）证明了单个特定生物标志物分子的PPB检测水平。 5）证明同时pPB检测不同生物标记的模拟混合物。 6）从概念上设计了小足迹II期原型。商业化：拟议的研究将为随后在II和III阶段的初始工具设计的简化和微型化准备方面。在此开发过程中，我们将与医疗设备制造商合作，协助制造，FDA批准和营销。将探索更多用于商业化的市场细分市场，以供其更广泛，更一般的医疗用途。