Emergency Awards RADx-RAD: Novel Biosensing for Screening, Diagnosis and Monitoring of COVID-19 From Skin and The Oral Cavity (R44 Clinical Trial Not Allowed) | RFA OD 20 020

Opportunity Information: Apply for RFA OD 20 020

This funding opportunity is an NIH Small Business Innovation Research (SBIR) solicitation that uses the R44 mechanism and is designed specifically for direct-to-Phase II projects, meaning applicants are expected to already have enough prior work to justify moving straight into a Phase II-style development and validation effort rather than starting with a Phase I feasibility study. The program sits under the RADx-RAD effort and focuses on fast, practical innovation for COVID-19 response, while also aiming to leave the country better prepared for future pandemics involving new or unknown viruses. The grant is titled "Emergency Awards RADx-RAD: Novel Biosensing for Screening, Diagnosis and Monitoring of COVID-19 From Skin and The Oral Cavity (R44 Clinical Trial Not Allowed)," and the core theme is developing new biosensing approaches that are non-traditional compared to standard nasal swabs, PCR tests, or antigen tests.

The scientific and technical emphasis is on portable devices that can reliably connect measurable biomarkers coming from either human skin or the oral cavity with COVID-19 status in both symptomatic and asymptomatic people. In other words, the program is not just looking for interesting signals; it is looking for devices and associated methods that can produce dependable associations between those signals and infection or disease state, in real-world screening and monitoring contexts. The FOA highlights that the intended settings include clinical environments, community settings, and everyday use, which signals a strong interest in practical workflows, usability, and deployment at the point of care rather than lab-bound procedures.

For skin-based biosensing, the solicitation is especially focused on detecting volatile organic compounds (VOCs), essentially odor or scent-like chemical signatures that emanate from skin. The expectations are that sampling should be passive and noninvasive and suitable for point-of-care use, implying minimal burden on the person being tested and minimal complexity for the operator. The FOA explicitly mentions that acceptable or encouraged technical approaches can include electronic nose (E-nose) technology and gas chromatography (GC). The skin-focused portion of the effort is branded within the announcement as SCENT, short for "Screening for COVID-19 by E-Nose Technology," which underscores how central VOC-based sensing is to the skin track of this program.

For oral-cavity biosensing, the opportunity is broader in the kinds of measurable signatures it will consider. The oral cavity is framed as a rich sampling site where biological, chemical, and physical biosignatures related to COVID-19 may be accessible. The FOA points to sample sources such as exhaled breath and droplets, saliva, and oral tissues, and it indicates interest in approaches that can capture signatures tied to the onset, progression, and resolution of COVID-19. The announcement also signals a preference for non-invasive measurements that can be real-time and potentially continuous or periodic, which suggests devices that can be used for ongoing monitoring rather than one-time testing only. At the same time, it notes that oral biosensing technologies should be thoroughly characterized as safe and effective in preclinical studies, implying the NIH expects a credible preclinical foundation before expanding into later-stage product development.

A major cross-cutting requirement is the integration of artificial intelligence capabilities into these devices or systems. The FOA is not just about building a sensor; it is about building an end-to-end tool that combines biosignal capture with AI-enabled interpretation to support detection and diagnosis, and potentially prediction, prognosis, and monitoring. That framing implies interest in systems that can take complex sensor outputs (for example, multi-analyte VOC patterns or multi-sensor breath signatures) and translate them into clinically meaningful outputs through data-driven modeling, while being robust across varied populations and settings.

Eligibility is limited to small businesses, consistent with SBIR rules, and the funding instrument is a grant. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible, although foreign components as defined under NIH policy may be allowed in some cases. The opportunity number is RFA-OD-20-020, the sponsoring agency is the National Institutes of Health, and the original closing date listed is September 18, 2020, with a creation date of August 6, 2020. The announcement is categorized under discretionary funding and falls broadly within health-related R&D priorities, as reflected by its multiple CFDA listings.

Finally, the "Clinical Trial Not Allowed" label is an important boundary condition: applicants should propose development, engineering, and validation activities that do not meet NIH’s definition of a clinical trial under this mechanism and FOA. In practical terms, the solicitation is geared toward advancing and packaging biosensing technologies into portable, safe, effective, AI-enabled devices that can be deployed for screening and monitoring, while keeping the proposed human-related work within non-clinical-trial parameters established by NIH guidance for this specific R44 funding call.

• 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 (R44 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, 93.838, 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.

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