Phase II Amount
$3,000,000
The United States Air Force, one of the eight U.S. uniformed services, is unique in its ability to travel far distances in short periods of time. Of necessity, the USAFs mobility provides it unique status and unique needs. Mobility itself has become a major issue with the Covid-19 pandemic infection now ravaging almost all corners of the globe. While unique in its rapid spread and ability to survive, Covid-19 teaches us that such an epidemic/pandemic can occur anywhere. The USAF would like to ensure that its combat forces are able to be protected by the earliest detection methods available using portable systems. It also wants to securely connect to a dedicated health care service as needed so the correct diagnosis can lead to correct and timely therapeutic intervention. Aviana Molecular Technologies, a development stage company, has created a unique radio frequency based portable diagnostic system that can accurately identify people in earlier stages of infection, well before a fever or other symptoms manifest. Aviana has generated data using a functional laboratory prototype for detecting and quantifying proteins, antibodies, and DNA/RNA. Our platform can be rapidly developed for newly emergent pathogens, we have generated preliminary data for antigen detection of influenza, a virus similar to SARS-CoV-2. We have also generated data for the detection of Lyme serology demonstrating that our system works in the presence of whole blood without the need for sample processing. The current pandemic provides an opportunity for Avianas early detection diagnostic system to be extremely relevant. Work completed to date will allow for rapid translation into a portable unit along with the biological data needed for FDA EUA authorization. Accordingly, we propose a development plan to deliver to the USAF, a ruggedized, portable diagnostic system for high accuracy and earliest COVID-19 viral detection and serology tests for combat forces in any setting as follows: Sensor: Build an improved sensor which contains a flow cell for fluid flow and protection of the electronics. In addition, the sensor will have a built-in connection to the reader. Assay Development and Evaluation: Develop and optimize COVID-19 assays for viral detection and serology tests using the protected sensor. Obtain data for limit of detection, sensitivity, and specificity for both tests. Cartridge: Design and build a cartridge to enclose the sensor and for fluid flow which can adapt to either a buffer based sample, such as nasal swab or saliva, and/or finger-pick whole blood for the viral detection and serology tests, respectively. Reader: The scope of the reader is to build a radio-frequency board limited to the frequency measures involved in our sensors. Software: This will consist of adapting the current proprietary software algorithm into the radio-frequency board to create a graphical user interface which seamlessly connects the algorithm to the results for the end user.
