High Sensitivity, Low Complexity, Multiplexed Diagnostic Devices

Preparing for outbreaks caused by biowarfare agents (BWAs) is one of the central pillars of our country's defense strategy. While there are point-of-need devices for detecting BWAs from environmental samples, there is no FDA-cleared point-of-care diagnostic test that can diagnose illnesses caused by BWAs. We propose to develop a solution using our patented point-of-care (POC) diagnostic technology called the PreparedNow® System, which includes a consumable cartridge, a mating adapter, and a standard smartphone as the instrument. All components and reagents required to complete the test are integrated into the consumable cartridge, including all sample preparation and a fully automated multiplexed chemiluminescent immunoassay. No pumps, power, or complex valves are necessary for our highly differentiated solution. Owing to its inherent multiplexing capabilities, the system will detect 5+ BWAs that are of high priority to the US Defense Department. In addition to developing this initial panel, we will demonstrate the PreparedNow® System's capability of an open-architecture platform for use by the Defense Department in the case of an unexpected outbreak or attack using an agent not included on the initial panel.