SBIR Phase II: Novel progesterone biosensor for monitoring fertility health

This Small Business Innovation Research (SBIR) Phase II project provides more 7.7 million women in the U.S. struggling with infertility a quantitative and affordable way to assess their ovulatory health. This progesterone biosensor is the first outcome of a platform technology built to improve at-home blood diagnostics and telehealth implementation. This project will produce a novel class of inexpensive, real-time, and point-of-care biosensors. The commercialization of this product may also increase public engagement and comfort with biosensors and at-home diagnostics. In concert with informational videos, website pages, and workshops the commercialization of this product will improve scientific literacy. Finally, the affordability of this product may help narrow the disparity of access to fertility technology allowing for more socioeconomically disadvantaged and underserved populations equal opportunity to assess their fertility. This Small Business Innovation Research (SBIR) Phase II project is developing a novel class of biosensors for progesterone. The technical hurdles to be addressed are to first translate optical transduction technology onto low-cost paper strips, then to determine the efficacy of the biosensors as paper test strips. The team will then develop a low-cost and portable measurement device which reads the paper lateral flow strips. The anticipated technical results are a lateral-flow strip device which can measure progesterone from clinical blood samples of women who have never been pregnant, women with Polycystic Ovary Syndrome (PCOS), pre-menopausal women, and post-menopausal women down to levels which indicate successful ovulation. 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.