STTR Phase I: Novel progesterone biosensor for monitoring fertility health

这个小企业技术转让计划（STTR）第一阶段项目的更广泛的影响/商业潜力是为美国770万患有不孕症的妇女提供定量和负担得起的方法来评估她们的排卵健康。这种孕酮生物传感器是一种平台技术的第一个成果，它可以扩展家庭血液诊断和远程医疗分析。该项目将生产出第一种新型的廉价、实时和即时生物传感器，这些传感器将影响多个领域和市场，如人类和动物医疗保健、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保健的机会。 该项目开发了一种装置，用于测量从未怀孕的妇女、卵巢疾病妇女、绝经前和绝经后妇女等患者血液样本中具有临床意义的低水平孕酮。该小企业技术转让计划（STTR）第一阶段项目正在开发一种全新的生物传感器，用于生理学上重要的分子，孕酮是第一个例子。本提案中所提出的工作要解决的技术障碍是首先将光学换能技术转换到低成本的纸带上。此外，确定这种新型生物传感器是否可以从血液中测量分子，如孕酮，以达到临床使用和商业化所需的标准。最后，确定一个低成本和便携式测量设备的临床要求的影响，以读取纸侧流strips.This奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

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.