November 25, 2020
PA-20-135 - Emergency Competitive Revision to Existing NIH Awards (Emergency Supplement - Clinical Trial Optional)
RFA-OD-20-021 - Emergency Awards RADx-RAD: Novel Biosensing for Screening, Diagnosis and Monitoring of COVID-19 From Skin and The Oral Cavity (Fast-Track STTR Clinical Trial Not Allowed)
RFA-OD-20-017- Emergency Awards RADx-RAD: Screening for COVID-19 by Electronic-Nose Technology (SCENT) (U18 Clinical Trial Not Allowed)
RFA-OD-20-020 - Emergency Awards RADx-RAD: Novel Biosensing for Screening, Diagnosis and Monitoring of COVID-19 From Skin and The Oral Cavity (Direct to Phase II SBIR Clinical Trial Not Allowed)
Office of The Director, National Institutes of Health (OD)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Dental and Craniofacial Research (NIDCR)
NIH is issuing this NOSI in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This emergency NOSI from the National Institutes of Health (NIH) provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Radical (RADx-rad) initiative. The goal of the RADx-rad initiative is to encourage the development of novel, non-traditional approaches to identify the current SARS-CoV-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, the goal of this NOSI is to advance early stage biosensing technologies intended for the detection of volatile organic compounds (VOCs) emanating from skin and/or multiple (i.e., biologic, chemical and physical) biosignatures captured from the oral cavity in COVID-19. The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020. Applications to this NOSI are limited to NIH Centers for Accelerated Innovations (NCAI).
SARS-CoV-2 is a novel coronavirus that has recently been identified as the causative agent of COVID-19, a respiratory disease that exhibits a wide range of clinical outcomes from asymptomatic and mild disease to severe viral pneumonia, Acute Respiratory Distress Syndrome (ARDS), Multisystem Inflammatory Syndrome in Children (MIS-C), acute kidney injury, thrombotic disorders, chemosensory dysfunction, and serious cardiac, cerebrovascular and vascular complications. On March 11, the SARS-CoV-2 outbreak was classified as a pandemic by the WHO. Research is an important component of the public health emergency response before, during and after the emergency. The United States Food and Drug Administration (FDA)-authorized COVID-19 diagnostic testing is critical for slowing the spread of the virus and preventing future outbreaks. Given this, there is an urgent public health need for the National Institutes of Health (NIH) to support the development of a variety of approaches to testing.
Expanding the capacity, throughput, and regional placement of existing technologies and accelerating the development of new technologies will contribute significantly to the current national efforts to curb the COVID-19 pandemic. To help meet this need, NIH launched the Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. The RADx initiative is a national call for scientists and organizations to bring their innovative ideas for new COVID-19 testing approaches and strategies.
As a part of this initiative, the NIH developed the RADx Radical (RADx-rad) project. RADx-rad will support new, non-traditional approaches, including unconventional screening, biological or physiological markers, new platforms, and point-of-care devices, that address current gaps in COVID-19 testing. The program will also support new or non-traditional applications of existing approaches to enhance their usability, accessibility, and/or accuracy. Despite the variety of activities included, the overall RADx-rad effort will be centrally aligned and coordinated to harmonize the data collection, storage, and management, providing an opportunity to further explore and identify additional approaches to understand this novel virus. Beyond the current crisis, it is anticipated that the technologies advanced through RADx-rad may also be applicable to other, yet unknown, infectious agents.
Biosensing and detection technologies submitted to this initiative should provide reliable associations between biomarkers emanating from skin or the oral cavity to patients with symptomatic and asymptomatic COVID-19. Leveraging the accessibility of human skin and the oral cavity, this FOA seeks (1) to advance novel biosensing technologies that are innovative, safe, and effective, and (2) to implement such technologies into devices with integrated artificial intelligent (AI) systems for the detection, diagnosis, prediction, prognosis and monitoring of COVID-19 in clinical, community and everyday settings.
To this end, dedicated engineering and artificial intelligence systems are required. For skin monitoring, the device can include Electronic-nose (E-nose) technology or Gas Chromatography (GC). Thus, biosensing technologies targeting VOCs emanating from skin or the oral cavity will be referred to as SCENT (Screening for COVID-19 by E-Nose Technology). Oral biosensing devices may consist of technologies that are thoroughly characterized as safe and effective in preclinical studies to conform to and perform in the oral cavity. Non-invasive, real-time, continuous or periodic measurements of VOCs and other biomarkers in breath, droplets, tissues and other samples emanating from the oral cavity as signatures of onset, progression, and resolution of COVID-19 are desirable
Multidisciplinary collaborations are expected to ensure project success. Disciplines may include: Biomedical engineers, material scientists, biosensing experts, software engineers, chemists, dentists, clinicians, virologists, clinical trialists, biostatisticians, data analysts and other relevant experts in academia and industry.
Applications will be evaluated for scientific and technical merit by an appropriate internal review panel convened by NIH staff, in accordance with the review criteria specified in PA-20-135 as well as these additional review criteria:
Funds awarded using appropriations provided by the “Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139” will be issued in unique subaccounts in the HHS Payment Management System and will require separate financial reporting from any other funds awarded.
Application and Submission Information
Application due date: December 4, 2020 by 5:00 PM local time of applicant organization.
Submit applications for this initiative in response to the following funding opportunity announcement (FOA) or the subsequent reissued equivalent through the expiration date of this notice:
Eligible existing grants that can be revised in response to this NOSI are limited. Only the listed NIH programs of participating Institutes and Centers are eligible for this NOSI, as follows:
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.
Amanda Melillo, Ph.D.
National Institute of Dental and Craniofacial Research (NIDCR)