STTR Phase I: Novel progesterone biosensor for monitoring fertility health

这项小型企业技术转移计划（STTR）第一阶段项目的广泛影响/商业潜力是为美国770万患有不孕症的妇女提供一种定量和负担得起的方法来评估她们的排卵健康。这种黄体酮生物传感器是平台技术的第一个成果，该技术可以扩展远程医疗保健的家庭血液诊断和分析。该项目将生产第一种新型廉价、实时和即时生物传感器，将影响多个领域和市场，如人类和动物保健、农业、国防和生物制造。初步应用将进一步扩大服务不足人口获得优质医疗保健的机会。拟议的项目开发了一种设备，用于从患者的血液样本中测量具有临床意义的低水平黄体酮，包括从未怀孕的妇女、卵巢疾病妇女、绝经前和绝经后妇女。这个小型企业技术转移项目（STTR）的第一阶段项目正在开发一种全新的生物传感器，用于检测生理上重要的分子，黄体酮是第一个例子。本提案中提出的工作需要解决的技术障碍是首先将光学转导技术转化为低成本的纸条。此外，确定这种新型生物传感器是否可以测量分子，如黄体酮，从血液到临床使用和商业化所需的标准，从纸试纸。最后，确定影响临床需求的低成本和便携式测量设备读取纸侧流条。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Technology Transfer Program (STTR) Phase I project is to provide 7.7 M women in the US struggling with infertility a quantitative and affordable way to assess their ovulatory health. This progesterone biosensor is the first outcome of a platform technology that to expand at-home blood diagnostics and analysis for remote health care. This project will produce the first of a novel class of inexpensive, real-time, and point-of-care biosensors that will impact multiple fields and markets, such as human and animal healthcare, agriculture, national defense, and biomanufacturing. The initial application will further expand access to quality health care for underserved populations. The proposed project develops a device to measure progesterone at clinically meaningful low levels from blood samples for patients including women who have never been pregnant, women with ovarian disorders, pre-menopausal and post-menopausal women.This Small Business Technology Transfer Program (STTR) Phase I project is developing an entirely novel class of biosensors for physiologically important molecules with progesterone being the first example. The technical hurdles to be addressed by the proposed work in this proposal are to first translate optical transduction technology onto low-cost paper strips. Furthermore, determine if this new class of biosensors can measure molecules, such as progesterone, from blood to criteria required for clinical use and commercialization from paper test strips. Lastly, determine the impact of clinical requirements for a low-cost and portable measurement device to read the paper lateral flow strips.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.