I-Corps: Translation Potential of an Enhanced Fluorescence-based Diagnostic Technology for the Detection of Lyme Disease

The broader impact of this I-Corps project is the development of an enhanced fluorescence-based diagnostic technology for the detection of antibodies and other biomarkers for disease diagnostics. The base technology has been demonstrated for diagnosing high profile diseases including COVID-19 and Lyme disease. For this I-Corps effort, Lyme disease has been chosen as the beachhead market due to the current diagnostic challenges, and the growing market for fast and accurate Lyme disease diagnostic technologies. The accepted standard for Lyme disease, known as standard two-tiered testing (STTT) is time consuming, requires specialists to run, and can be unreliable, especially for early stages of the disease. This technology has proven to alleviate these pain points, providing rapid and accurate Lyme disease diagnosis, especially for early Lyme disease patients. The platform has also been utilized for detecting RNA-protein and DNA-protein interactions, which potentially broadens its utility for a large number of different disease diagnostic applications, biomarker discovery, and biological / pharmaceutical research applications. The technology may have impact in several clinical and biological research fields. This I-Corps project utilizes experiential learning coupled with a first-hand investigation of the industry ecosystem to assess the translation potential of the technology. This solution is based on the development of a photonics-based Lyme disease diagnostic platform. Lyme disease is the most common vector-borne disease in the United States and, despite advances, remains a considerable diagnostic challenge. Confirmatory diagnosis requires a second test, performed in series, often in batches, and at a centralized laboratory. This delay can lead to considerable morbidity in disseminated Lyme disease. This technology is a low-cost, highly sensitive, fluorescence-based platform, which provides a rapid, easy-to-use, and highly accurate Lyme test that could be used outside traditional clinical laboratories or for more rapid and accurate diagnosis within clinical laboratories. The proof-of-principle research positions the technology as a rapid (<40 minutes total test time) and reliable alternative to traditional Lyme tests, while retaining the full sophistication of a two-tiered testing system. 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.