SBIR Phase II: Enhancing Performance and Achieving Commercial Readiness for the PQS1.0 Rapid Phenylalanine Blood Level Monitor

This Small Business Innovation Research (SBIR) Phase II project addresses a pressing need for a rapid and user-friendly method to monitor blood phenylalanine levels in individuals with phenylketonuria (PKU), a lifelong genetic disorder impairing phenylalanine processing, an amino acid found in many common foods. Left untreated or poorly managed, PKU can result in intellectual disabilities, behavioral issues, and severe health complications. In the U.S., an estimated 20,000 to 35,000 individuals grapple with PKU, demanding consistent blood phenylalanine level monitoring as part of their disease management. The annual costs of PKU care can vary from $15,000 to $200,000 per individual, with higher costs linked to inadequate management, leading to irreversible damage and substantial healthcare services. Currently, monitoring occurs with intervals of 3 to 5 days or even up to two weeks, constrained by factors like test sites, facility availability, and turnaround times. Ideally, PKU monitoring should align with individual needs, occurring daily in sync with diet, age, health factors, and gestational period. Enhanced monitoring frequency is widely recognized as beneficial, and this project aims to improve PKU care by providing accessible and frequent monitoring for improved patient outcomes. This Small Business Innovation Research (SBIR) Phase II project aims to develop a rapid phenylalanine monitor for phenylketonuria (PKU) patients. The project offers rapid analysis of blood phenylalanine levels to enhance patient outcomes and improve the current standard of care. Consisting of a test strip and a test device, the system accepts a blood drop from a finger prick. The test strip conditions the blood sample with specific analytes before the test device analyzes the sample. The project's core focus is optimizing product design and system algorithms, enabling cost-effective manufacturing and deployment for end-users. 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.