The detection of antigens or antibodies in blood and other fluids is a critical step in the diagnosis and treatment of infectious, autoimmune, neoplastic and inherited human diseases. The identification of these analytes is usually done in a clinical laboratory which employs either culture methods or photometric ELISA immunoassays assays as standard methods. These processes can take hours to days to weeks to confirm the presence of these agents. We have developed a novel proprietary technology, built around the marriage of magnetic immunobead supports and an Inter-Digitated Array Biosensor (IDA), to accelerate these clinical analyses and provide equally sensitive and specific results in only a few minutes. This translates into a significant reduction in the time needed for diagnosis and effective treatment of affected patients. The technology affords a uniquely robust electrochemical detection of analytic reporters. These biosensors can be flexibly adapted for use in both discrete (miniaturized, handheld) and high throughput (continuous flow, desk top) instrumental formats. However, as a first step, the goal of this phase I proposal is to focus on the optimization and validation of an initial clinically important methodology, an HIV antibody screening assay, using our prototype laboratory-scale breadboard instrumentation. These results will pave the way for future phase II studies in which prototype high throughput instruments will be constructed to perform HIV antibody screening (as well as several clinically aligned methods), and advance development to beta testing and FDA 510k trials. PROPOSED COMMERCIAL APPLICATION: The in vitro medical diagnostic market is over $17 billion annually, with nearly half the revenues coming from testing via immunoassays. ELISA is the primary technology used for immunoassays. Our IDA technology can be adapted to any ELISA method, and has the potential to dominate both the high throughput mass testing and point of care analysis markets. The development of this magnetically accelerated electrochemical detection technology could lead to a multi-billion dollar industry.
