SBIR Phase I: Point-of-Care Detection of HSV-1 Keratitis using Minimally Invasive Ocular Inserts

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a cost-effective, rapid point-of-care diagnostic test to differentiate ocular herpes infections from other types of eye infections. Ocular herpes is the leading cause of infectious blindness in the United States. Current diagnostic methods are often inaccurate and cumbersome, leading to frequent misdiagnoses and inappropriate treatments that exacerbate symptoms and cause further ocular damage.

A rapid and minimally invasive ocular herpes test would ensure patients receive proper treatment, improve patient outcomes, and reduce total healthcare costs associated with misdiagnosis. With approximately 7 million annual visits to eye specialists, urgent care centers, and primary care physicians for eye infections potentially linked to ocular herpes, this test holds substantial commercial potential.

By equipping clinicians with an effective tool to quickly screen for the herpes virus and monitor recurrent cases, the test addresses a crucial need. Additionally, this project will lay the groundwork for developing further point-of-care tests to accurately diagnose other major causes of infectious blindness.

This Small Business Innovation Research (SBIR) Phase I project will focus on creating a point-of-care diagnostic test for eye specialists and urgent care clinicians to quickly and accurately identify ocular herpes infections. This project will consist of the development, fabrication, and analysis of an ocular sampling tool and point-of-care assay to detect active herpes infections.

The objectives of this project are to (i) reformat a previously developed laboratory test that has successfully detected ocular herpes infections in animal models into a user-friendly, accurate diagnostic tool suitable for urgent care settings, (ii) optimize the test to meet the necessary detection limits required for high diagnostic accuracy, and (iii) validate the test can accurately detect active herpes infections in mice models over the typical infection timeline. If successful, the project will yield the first rapid diagnostic test prototype capable of accurately detecting ocular herpes infections 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.