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 20 021

Opportunity Information: Apply for RFA OD 20 021

The National Institutes of Health (NIH) issued this funding opportunity (RFA-OD-20-021) under the RADx initiative to speed up the development of new, non-traditional biosensing technologies for COVID-19. The focus is on fast, portable screening, diagnosis, and monitoring approaches that do not rely on conventional specimen types or lab-centered workflows. In practical terms, the program is looking for devices that can detect active SARS-CoV-2 infection or measurable biological indicators of COVID-19 disease, with an eye not only toward the current outbreak but also toward future pandemics where the next virus may be unknown and rapid, scalable sensing platforms could be repurposed quickly.

The solicitation is specifically aimed at biosensors that use the skin and/or the oral cavity as the sampling site. For skin-based approaches, the expectation is passive, noninvasive sensing at the point of care, with emphasis on detecting volatile organic compounds (VOCs), meaning odor-like chemical signatures that emanate from the skin. For oral-cavity approaches, the opportunity is broader: applicants can target biological, chemical, and physical biosignatures associated with COVID-19 that can be collected from exhaled breath and droplets, saliva, or tissues in the mouth. This can include VOCs in breath, but it can also extend to other measurable signals that correlate with infection or disease state, provided the device can produce results that reliably associate those oral/skin biomarkers with COVID-19 status in both symptomatic and asymptomatic people.

From a development and commercialization standpoint, the mechanism is a Fast-Track STTR (Small Business Technology Transfer) grant, which is designed to move projects more quickly from early feasibility work into more advanced development within a single combined application structure. The applicant organization must be an eligible U.S. small business, and the program is oriented toward building portable, innovative devices that could realistically be used outside traditional laboratory settings, including point-of-care environments where rapid screening and triage matter. The notice also makes it clear that this specific Fast-Track STTR opportunity does not allow clinical trials, so applicants would be expected to design their work around technology development and validation activities that do not meet NIH’s definition of a clinical trial.

Eligibility is limited to small businesses, and there are important restrictions on foreign involvement. Non-U.S. entities (foreign institutions) cannot apply, and non-U.S. components of U.S. organizations are also not eligible to apply under this announcement. However, the NIH policy concept of a “foreign component” may be allowed in some circumstances as defined in the NIH Grants Policy Statement, which typically means certain discrete elements of a project may occur outside the U.S. if they are well-justified, properly disclosed, and approved, even though the applicant organization itself must be domestic and eligible.

Administratively, the opportunity is a discretionary grant program run by NIH, created on August 6, 2020, with an original closing date of September 18, 2020. It is listed under multiple CFDA numbers associated with NIH and related public health research programs. While the summary information provided does not specify an award ceiling or the expected number of awards, the intent is clearly aligned with rapid, pandemic-relevant technology development: bringing forward biosensing platforms that can connect measurable skin or oral biomarkers to COVID-19 infection status in a dependable way, and that could be adapted to future outbreak pathogens when speed, portability, and noninvasive sampling become critical constraints.

• The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "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)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.233, 93.273, 93.286, 93.307, 93.310, 93.350, 93.837, 93.839, 93.840, 93.846, 93.865, 93.879.
• This funding opportunity was created on 2020-08-06.
• Applicants must submit their applications by 2020-09-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for RFA OD 20 021

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