NIH is issuing this FOA in response to the declared public health emergency issued by the Secretary, Department of Health and Human Services (DHHS), for the 2019 Novel Coronavirus (COVID-19). This emergency cooperative agreement funding opportunity announcement (FOA) provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics Radical (RADx-rad) Initiative. The goal of RADx-rad is to solicit proposals for the development of novel, nontraditional approaches to identify the current SARS-C oV-2 virus or other markers of the COVID-19 disease that can be used in future outbreaks of COVID-19 and that could be applicable to other, as yet unknown, viruses. Specifically, this FOA seeks to fund a single cooperative agreement for a RADx-rad Data Coordination Center (DCC) to serve as a communication center and data hub for RADx-rad awardees. The funding for this award is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.
Specifically, this initiative seeks to advance the development of novel, safe and effective biosensing and detection technologies for volatile organic compound (VOC) signatures of COVID-19 from human skin or the oral cavity. To this end, leveraging dedicated engineering and artificial intelligence systems is required. This initiative anticipates the implementation of such technologies in everyday settings and routines for detection, diagnosis, prediction, and monitoring of COVID-19 in clinical, community or applied settings. It is envisioned that these technologies will complement traditional virus and antibody detection to monitor the onset, progression, and resolution of COVID-19.
Because of the short program timeline, Quality by Design (QbD) principles must be leveraged in early research and development of SCENT technologies. A holistic strategy that accounts for end-state manufacturing, production, and usability is expected. Early identification of critical product attributes (e.g., comparable accuracy with the current standard, safety, portability, etc.) and process parameters (e.g., ruggedness of materials used in the device, but also built-in process analytical technologies to ensure acceptable device function) are required. Design of experiment (DoE) techniques is essential. These preclinical development strategies will increase the likelihood of success in meeting eventual clinical performance requirements.
Submit your notification at the InfoReady link below to provide your contact information no later than 4:00 p.m. on the internal submission deadline:
Questions concerning the limited submissions process may be submitted to limitedsubs@psu.edu.