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.Apply for RFA OD 20 020
- 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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FAQs: NIH SBIR R44 (Direct-to-Phase II) RADx-RAD Biosensing Opportunity
What is this funding opportunity?
This is an NIH Small Business Innovation Research (SBIR) funding opportunity using the R44 mechanism. It is part of the RADx-RAD effort and supports fast, practical innovation for COVID-19 response while strengthening preparedness for future pandemics involving new or unknown viruses.
What is the official title of the grant opportunity?
The opportunity 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)."
What is the opportunity number and sponsoring agency?
The opportunity number is RFA-OD-20-020, and the sponsoring agency is the National Institutes of Health (NIH).
What mechanism is being used (R44) and what does it imply?
This solicitation uses the SBIR R44 mechanism. It is designed for projects advancing toward development and validation in a Phase II-style effort under SBIR rules, with eligibility limited to small businesses.
Is this a direct-to-Phase II solicitation?
Yes. It is designed specifically for direct-to-Phase II projects, meaning applicants are expected to already have enough prior work to justify moving straight into Phase II-type development and validation rather than starting with a Phase I feasibility study.
What is the main technical theme of the solicitation?
The core theme is developing non-traditional biosensing approaches for COVID-19 screening, diagnosis, and monitoring using signals from human skin or the oral cavity, rather than standard nasal swabs, PCR tests, or antigen tests.
What kinds of products or systems is NIH looking for?
The emphasis is on portable devices (and associated methods) that can reliably link measurable biomarkers from skin or the oral cavity to COVID-19 status in both symptomatic and asymptomatic people, in real-world screening and monitoring contexts.
What settings are these biosensing technologies expected to work in?
The FOA highlights use in clinical environments, community settings, and everyday use. This points to interest in practical workflows, usability, and point-of-care deployment rather than lab-bound procedures.
What does NIH mean by “reliably connect measurable biomarkers” to COVID-19 status?
It means the program is not only interested in identifying potentially interesting signals. It is looking for dependable associations between measured biosignatures and infection or disease state that hold up in screening and monitoring situations.
What is the skin-based biosensing focus in this FOA?
For skin-based biosensing, the solicitation is especially focused on detecting volatile organic compounds (VOCs), described as odor or scent-like chemical signatures emanating from skin.
What sampling characteristics are expected for skin-based approaches?
Skin sampling is expected to be passive and noninvasive, and suitable for point-of-care use. The stated intent is minimal burden on the person being tested and minimal complexity for the operator.
What technologies are mentioned as acceptable or encouraged for skin VOC sensing?
The FOA explicitly mentions electronic nose (E-nose) technology and gas chromatography (GC) as acceptable or encouraged technical approaches for skin-based VOC detection.
What is SCENT in the context of this announcement?
The skin-focused effort is branded as SCENT, short for "Screening for COVID-19 by E-Nose Technology," underscoring the central role of VOC-based sensing for the skin track.
What is the oral-cavity biosensing focus in this FOA?
The oral-cavity track is broader in the types of measurable signatures considered. The oral cavity is framed as a rich sampling site where biological, chemical, and physical biosignatures related to COVID-19 may be accessible.
What oral sample sources are specifically mentioned?
The FOA points to sample sources such as exhaled breath and droplets, saliva, and oral tissues.
What kinds of COVID-19-related information should oral biosensing capture?
The FOA indicates interest in signatures tied to the onset, progression, and resolution of COVID-19, suggesting value in monitoring across different stages of disease.
Does the FOA prefer non-invasive or real-time oral measurements?
Yes. The announcement signals a preference for non-invasive measurements that can be real-time and potentially continuous or periodic, aligning with devices suitable for ongoing monitoring rather than only one-time testing.
Are there expectations for preclinical evidence for oral biosensing technologies?
Yes. The FOA 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 moving forward.
Is artificial intelligence (AI) required or optional?
AI is a major cross-cutting requirement. The FOA emphasizes integrating AI capabilities into devices or systems so that biosignal capture is paired with AI-enabled interpretation to support detection and diagnosis, and potentially prediction, prognosis, and monitoring.
What role is AI expected to play in these biosensing systems?
The framing suggests end-to-end tools that translate complex sensor outputs (for example, multi-analyte VOC patterns or multi-sensor breath signatures) into clinically meaningful outputs through data-driven modeling, with robustness across varied populations and settings.
Who is eligible to apply?
Eligibility is limited to small businesses, consistent with SBIR rules. The funding instrument is a grant.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply.
Are non-U.S. components of U.S. organizations eligible?
No. 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.
Is this opportunity classified as allowing clinical trials?
No. The FOA is labeled "Clinical Trial Not Allowed," which is an important boundary condition for what can be proposed under this mechanism and solicitation.
What does “Clinical Trial Not Allowed” mean for proposed work?
Applicants should propose development, engineering, and validation activities that do not meet NIH’s definition of a clinical trial under this mechanism and FOA. The solicitation emphasizes advancing portable, safe, effective, AI-enabled biosensing technologies while keeping human-related work within NIH’s non-clinical-trial parameters for this R44 call.
What is the original closing date and when was the opportunity created?
The original closing date listed is September 18, 2020, and the creation date is August 6, 2020.
How is this opportunity categorized?
The announcement is categorized under discretionary funding and falls within health-related R&D priorities, reflected by multiple CFDA listings.
What is the overarching public health goal beyond COVID-19?
While focused on COVID-19 response, the program also aims to leave the country better prepared for future pandemics involving new or unknown viruses.
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| Emergency Awards: RADx-rad Predicting Viral-Associated Inflammatory Disease Severity in Children with Laboratory Diagnostics and Artificial Intelligence (PreVAIL kIds) (R61/R33 Clinical Trial Optional) Apply for RFA OD 20 023 Funding Number: RFA OD 20 023 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $500,000 |
| 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) Apply for RFA OD 20 021 Funding Number: RFA OD 20 021 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Pilot resources for brain cell type-specific access and manipulation across vertebrate species (U01 Clinical Trial Not Allowed) Apply for RFA MH 20 556 Funding Number: RFA MH 20 556 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Fellows: Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (F32) Apply for RFA MH 20 620 Funding Number: RFA MH 20 620 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Cell Census Network (BICCN) Scalable Technologies and Tools for Brain Cell Census (R01 Clinical Trial Not Allowed) Apply for RFA MH 21 140 Funding Number: RFA MH 21 140 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: New Concepts and Early-Stage Research for Recording and Modulation in the Nervous System (R21) (Clinical Trial Not Allowed) Apply for RFA EY 21 001 Funding Number: RFA EY 21 001 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Basic Experimental Studies with Humans Required) Apply for PAR 21 144 Funding Number: PAR 21 144 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Clinical Trials Not Allowed) Apply for PAR 21 145 Funding Number: PAR 21 145 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Firearm Injury and Mortality Prevention Research (R01Clinical Trial Optional) Apply for PAR 21 192 Funding Number: PAR 21 192 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Firearm Injury and Mortality Prevention Research (R21/R33 Clinical Trial Optional) Apply for PAR 21 191 Funding Number: PAR 21 191 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Integration and Analysis of BRAIN Initiative Data (R01 Clinical Trial Not Allowed) Apply for RFA MH 21 135 Funding Number: RFA MH 21 135 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional) Apply for PAR 21 163 Funding Number: PAR 21 163 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Secondary Analysis and Archiving of BRAIN Initiative Data (R01 Clinical Trial Not Allowed) Apply for RFA MH 21 130 Funding Number: RFA MH 21 130 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $300,000 |
| Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional) Apply for PAR 21 162 Funding Number: PAR 21 162 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Limited Interaction Targeted Epidemiology (LITE-2): To Advance HIV Prevention (UG3/UH3 Clinical Trial Optional) Apply for RFA AI 21 018 Funding Number: RFA AI 21 018 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
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| Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional) Apply for PAR 21 233 Funding Number: PAR 21 233 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Development and Validation of Novel Tools to Probe Cell-Specific and Circuit-Specific Processes in the Brain (R01 Clinical Trial Not Allowed) Apply for RFA MH 21 175 Funding Number: RFA MH 21 175 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Optional) Apply for RFA NS 21 023 Funding Number: RFA NS 21 023 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $1,000,000 |
| BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3 Clinical Trial Optional) Apply for RFA NS 21 024 Funding Number: RFA NS 21 024 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $1,500,000 |
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