Oral Fluid NanoSensor Test (OFNASET)

描述（由申请人提供）：通过完全非侵入性手段检测和监测疾病状态的能力一直是诊断行业难以实现的目标。虽然口服液（唾液）很容易获得且完全无创，但其在临床诊断中的应用直到最近才得到证实。我们在加州大学洛杉矶分校的团队和其他研究人员已经证明，口腔液含有与血清相同的疾病生物标志物组成，尽管数量较少。作为NlDCR“基于唾液/口腔液的诊断技术开发”项目的一部分，该团队还展示了一种基于微流体的微/纳米传感器（口腔液MEMS/NEMS芯片[OFMNC]），用于超灵敏、超特异性地检测唾液中的口腔癌生物标志物。此应用程序包括三个高度响应的特定目标。目标1将开发“口腔液体纳米传感器测试（OFNASET）”作为手持和易于使用的仪器（OFNASET - instrument）和相关的微流体消耗品（OFNASET - cartridge）。该集成系统将能够同时快速检测多种唾液蛋白和核酸目标。目标2将根据诊断行业标准对OFNASET进行分析验证。目的3将初步证明OFNASET在临床口腔癌筛查中的临床应用。拟议的工作最终将设计上市前批准（PMA）临床试验，并在ide前会议上提交给FDA。我们的愿景是通过加速基于唾液的诊断的商业化来改善患者护理。我们相信，我们与GeneFluidics（生物纳米技术和微流体技术的领导者）和Becton Dickinson（世界第五大临床诊断公司）建立的战略联盟将弥合技术概念化和商业化之间的鸿沟，使我们的愿景成为现实。公众：该提案旨在实现开发、验证和获得FDA监管批准的工具的目标，这些工具可以被牙医和医生用于在办公室使用一滴唾液实时检测口腔癌。

DESCRIPTION (provided by applicant): The ability to detect and monitor disease states through totally non-invasive means has been an elusive goal for the diagnostic industry. While oral fluid (saliva) is readily available and completely non-invasive, its utility in clinical diagnostics has only recently been demonstrated. Our team at UCLA, and others, has shown that oral fluid harbors the same composition of disease biomarkers as serum, albeit in smaller quantities. The team has also demonstrated, as part of NlDCR's "Development of Technologies for Saliva/Oral Fluid Based Diagnostics" program, a microfluidic-based micro/nano sensor (Oral Fluid MEMS/NEMS Chip [OFMNC]) for the ultrasensitive, ultraspecific detection of oral cancer biomarkers in saliva. This application includes three highly responsive Specific Aims. Aim 1 will develop the "Oral Fluid NanoSensor Test (OFNASET)" as a handheld and easy to use instrument (OFNASE-lNSTRUMENT) and associated microfluidic consumables (OFNASE-CARTRIDGE). This integrated system will enable the simultaneous and rapid detection of multiple salivary protein and nucleic acid targets. Aim 2 will analytically validate the OFNASET according to diagnostic-industry standards. Aim 3 will preliminarily demonstrate the clinical utility of OFNASET for clinical oral cancer screening. The proposed work will culminate with the design of a pre-market approval (PMA) clinical trial to be presented to the FDA in a pre-IDE meeting. Our vision is to improve patient care by speeding the commercialization of saliva-based diagnostics. We believe that our established strategic alliances with GeneFluidics (a leader in bionanotechnology and microfluidics) and Becton Dickinson (the world's fifth largest clinical diagnostic company) will bridge the chasm between technology conceptualization and commercialization and make our vision a reality. For public: This proposal is to achieve the goal of develop, validate and achieve regulatory FDA approval of tools that can be used by dentists and doctors for in-office real time detection of oral cancer using a drop of saliva.