University of Southern California

Research

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)

Slots:                                                     1

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.

Link to Award:                                  https://grants.nih.gov/grants/guide/rfa-files/RFA-OD-20-018.html

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:

  1. 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:
  1. 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:
  1. 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:

In order to be responsive to this FOA, applicants must:

Budgetary Requirements:              Application budgets are not limited but need to reflect the actual needs of the proposed project.