SBIR Phase I: Portable Blood Diagnostic Technology Enabling Care Delivery Beyond Hospital Walls

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be the advancement of a portable, cost-effective rapid point of care diagnostic device that utilizes high sensitivity biosensors for detecting multiple blood-based biomarkers. Starting with reproductive hormones, this technology empowers clinicians to obtain rapid hormone level results to support time-sensitive clinical decisions in fertility treatments such as in-vitro fertilization and cryopreservation. This project aims to address capacity constraints in reproductive care, reduce cost of care, and enhance patient-centric treatment models. This project will lay the foundation to expand into other point of care applications, including the quantitative detection of high-sensitivity cardiac troponin and Alzheimer’s disease-related small proteins, improving clinical outcomes of chronic diseases. This Small Business Innovation Research (SBIR) Phase I project develops a point-of-care immunoassay system designed for use by lay users with minimal laboratory training to obtain simultaneous, quantitative measurements of three reproductive hormones. The research objectives include: (1) developing an integrated cartridge/analyzer system that automates serum separation and buffer dilution, ensuring high-sensitivity biomarker detection upon sample insertion, (2) optimizing the system for high accuracy and reproducibility, and (3) validating the system in human samples. If successful, this project will result in the first rapid diagnostic platform capable of demonstrating lab-comparable hormone quantification at the point of care. 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.