RFA-OD-20-018: Emergency Awards: Exosome-based Non-traditional Technologies Towards Multi-Parametric and Integrated Approaches for SARS-CoV-2 (U18 Clinical Trial Not Allowed)
Internal Deadline: First-come, first-served.
LOI: August 18, 2020
External Deadline: September 18, 2020
Award Information: Type: Cooperative Agreement
Funds Available and Anticipated Number of Awards: NIH intends to commit $10 million in total costs over a two-year period. NIH anticipates funding 5 awards.
Who May Serve as PI: Standard NIH eligibility requirements.
Process for Limited Submissions: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants.
Materials to submit include:
(1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
(2) CV – (5 pages maximum)
Purpose: The National Institutes of Health (NIH) is issuing this funding opportunity announcement (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 FOA provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Radical (RADx-rad) initiative. Specifically, this FOA seeks to use technologies developed for single extracellular vesicle, exosome, and extracellular RNA (exRNA) isolation and analysis and reposition them for the detection of SARS-CoV-2. The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.
Specific Research Objectives:
- Technology Development. Newly developed technologies and approaches for single exosome and exRNA isolation and analyses will be deployed for detection of SARS-CoV-2 virus RNA and/or protein, and detection of IgA, IgG, and IgM antibodies against the virus. Activities will include, but are not limited to:
- Development of technologies for screening for SARS-CoV-2 viral infection and COVID-19 based on novel technologies for single vesicle, exosome, and exRNA isolation.
- Demonstration of SAR-CoV-2 isolation effectiveness using clinically relevant biofluids from patients.
- Demonstration of greater than 95% diagnostic reliability, sensitivity, and specificity of detecting SARS-CoV-2.
- Clinical Testing and Validation. Data training sets must be collected on known (1) COVID-19 positive, symptomatic, (2) COVID-19 positive, asymptomatic and (3) COVID-19 negative subjects as determined by an FDA-approved method. Activities will include, but are not limited to:
- Validation of technologies and approaches using a cohort of COVID-19 patients and unaffected individuals representing population demographics inclusive of sex/gender, race, age and ethnicity.
- Regulatory Approval Plan. A plan for the regulatory approval of technologies, tests and approaches should be developed and submitted to the appropriate regulatory agency based on the data generated from research objectives 1 and 2. The application should describe the expected regulatory pathway for the technology and describe foreseeable regulatory risks that could impact the technology development. It should also describe how the technology would fit with current physician practice/standard of care. Activities will include, but are not limited to:
- Development of a detailed plan for the regulatory approval of technologies, tests and approaches to be submitted to the appropriate regulatory agency.
- Submission of newly developed technologies for detection and/or diagnosis of SARS-CoV-2 virus RNA and/or protein, and detection of antibodies against the virus to the FDA Center for Devices and Radiological Health (CDRH).
In order to be responsive to this FOA, applicants must:
- Repurpose single vesicle or exosome-based technology towards the detection of SARS-CoV-2.
- Include milestones towards progress and a timeline for project completion.
Budgetary Requirements: Application budgets are not limited but need to reflect the actual needs of the proposed project.