Novel Platform for Improving Access to and Efficacy of Fertility Treatments

 描述（由申请人提供）：本SBIR提案的目标是开发一种新技术，该技术有望为需要信号放大和精确定量的免疫测定提供妊娠试验样稳定性。目标1专注于开发用于全血中单个分析物的多路检测试剂盒，并证明与临床标准的性能等同。Aim 2将这些检测转化为一个独立的POC就绪平台。我们的初步数据显示，使用专有的SeLux平台在生理范围内进行的代表性分析物检测与临床标准具有良好的可比性，以及该方法的热稳定性和时间稳定性。基于这些结果，我们认为第一阶段概述的9个月开发计划将证明第二阶段中设备规模扩大和全面临床验证所需的基本平台功能。该团队非常适合这一计划，包括POC测试和纳米传感方面的专业知识，以及检测开发、微流体设计和光学检测方面的直接经验。此外，我们紧密的临床合作伙伴关系将最终客户嵌入到研发过程中。通过克服传统的免疫测定鲁棒性障碍并实现生物标志物组的并行检测，SeLux平台将迎来对基于价值的护理至关重要的POC设备的新时代。

 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.