Novel Platform for Improving Access to and Efficacy of Fertility Treatments

提高生育治疗的可及性和有效性的新平台

• 批准号: 9046502
• 负责人: ERIC STERN
• 金额: $ 21.65万
• 依托单位: SELUX DIAGNOSTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9046502
• 关键词: Antibodies; Appointment; Artificial nanoparticles; Bedside Testings; Biological Assay; Biological Markers; Blood specimen; Boston; Care Technology Points; Caring; Chemistry; Clinic; Clinical; Clinical Trials; Collaborations; Couples; Data; Data Collection; Detection; Development; Development Plans; Devices; Diagnostic; Doctor of Philosophy; Drops; Ensure; Enzymes; Estradiol; Estrus; Fertility; Fertilization in Vitro; Fingers; Formulation; Foundations; Future; Generations; Goals; Grant; Home environment; Hormones; Immunoassay; Improve Access; Individual; Industry; Infertility; Label; Life; Link; Medical; Methodology; Microfluidics; Monitor; Optics; Outcome; Ovarian; Paper; Pathway interactions; Patients; Performance; Phase; Physiological; Pregnancy Tests; Procedures; Process; Progesterone; Public Health; Publishing; Reagent; Research; Sampling; Signal Transduction; Small Business Innovation Research Grant; Stress; Technology; Time; Translating; Validation; Variant; Venipunctures; Veterans; Visit; Whole Blood; Woman; assay development; base; biomarker panel; commercialization; cost; cost effective; design; distinguished professor; experience; improved; infertility treatment; innovation; nanosensors; new technology; novel; parity; patient population; point of care; public health relevance; reproductive hormone; research and development; scale up; standard of care

 DESCRIPTION (provided by applicant): The goal of this SBIR proposal is to develop a novel technology that promises to confer pregnancy test-like stability to immunoassays requiring signal amplification and precise quantification. Aim 1 focuses on developing multiplex-ready assays for individual analytes from whole blood, and demonstrating performance parity with clinical standards. Aim 2 translates these assays to a single, self-contained, POC-ready platform. Our preliminary data show representative analyte detection using the proprietary SeLux platform in the physiologic range with excellent comparability with clinical standards, as well as thermal and temporal stabilities of the methodology. Based on these results, we believe the 9-month development plan outlined for Phase I will demonstrate the essential platform features required for device scale-up and full clinical validation in Phase II. The assembled team is uniquely suited to this plan, including expertise in POC testing and nanosensing, and direct experience in assay development, microfluidics design and optical detection. Furthermore, our close clinical partnership embeds the eventual customer in the research and development process. By overcoming the traditional immunoassay robustness barrier and enabling parallel detection of biomarker panels, the SeLux platform will usher in a new era of POC devices critical for value- based care.

 描述（由适用提供）：该SBIR提案的目的是开发一种新技术，有望在需要信号放大和精确定量的免疫测定时会召集妊娠试验样稳定性。 AIM 1专注于为全血的单个分析物开发多重准备评估，并通过临床标准证明表现均等。 AIM 2将这些评估转化为一个独立的，具有POC就绪的平台。我们的初步数据显示，在生理范围内使用专有的Selux平台代表分析物检测，其与临床标准以及方法论的热和临时系统具有良好的兼容性。基于这些结果，我们认为第I期概述的9个月开发计划将展示II期设备扩展和完整临床验证所需的基本平台功能。组装团队非常适合该计划，包括POC测试和纳米传感的专业知识，以及评估开发，微流体设计和光学检测方面的直接经验。此外，我们的亲密临床伙伴关系将活动客户嵌入了研究和开发过程中。通过克服传统的免疫测定稳健性障碍并实现生物标志物面板的并行检测，SELUX平台将迎来一个对基于价值护理至关重要的POC设备的新时代。