Over-the-Counter/Home Use Platforms for HIV Detection and Antiviral Therapy Monitoring FAQs
General
What is the purpose of the Over-the-Counter / Home Use Platforms for HIV Detection and Antiretroviral Therapy Monitoring solicitation?
The FY 2026–2030 NIH Strategic Plan for HIV and HIV-Related Research, coordinated by the NIH Office of AIDS Research (OAR), guides the largest public investment in HIV research, building on scientific progress and opportunities for advancing research to end the HIV pandemic. Despite scientific advances, HIV remains a major public health challenge, with persistent disparities in access and outcomes.
In collaboration with OAR, the National Institute of Nursing Research (NINR), and the National Institute of Mental Health (NIMH), the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is soliciting proposals through its Rapid Acceleration of Diagnostics (RADx®) program to advance technologies for HIV detection and/or ART monitoring that address specific unmet domestic needs.
This solicitation seeks over-the-counter (OTC) technologies that fit one or more of the following profiles:
- Qualitative whole blood assay to detect HIV infection and support prophylaxis (PrEP) initiation and/or monitoring
- Molecular test
- 4th generation Ag/Ab LFA test
- Low-cost antibody test
- Quantitative or semi-quantitative (≤1000 copies/ml required; preferred ≤200 copies/mL) whole blood assay for ART monitoring
Innovators should be mindful of 21 CFR 866.3956, 21 CFR 866.3957, and 21 CFR 866.3958 and how their technology will comply with the applicable instructions.
When can proposals be submitted?
Proposals may be submitted until 11:59 PM ET January 15, 2027. It is anticipated that proposal review will occur in January and February of 2027 with one or more awards announced shortly thereafter. The link to the current solicitation can be found here.
How will new or redesigned tests be developed?
Projects will follow a staged, milestone-driven approach for development. Ideas will be rapidly reviewed and assessed for feasibility, risk, and necessary support. Project progress will be closely monitored, and future support will be dependent upon achieving stated milestones.
Is the goal of the program to facilitate clearance of HIV over-the-counter tests by the U.S. Food and Drug Administration (FDA)?
Under this solicitation, NIBIB is seeking proposals to accelerate HIV testing platforms towards the evaluation, preparation, and readiness for clinical studies required for regulatory submission/clearance for use in the OTC/home use setting. However, the end point of this Funnel does not require innovators to reach the point of or make a submission to the FDA.
Is obtaining FDA clearance necessary before the test can be deployed in the United States?
Yes. FDA clearance is required for HIV tests to be marketed in the U.S.
How are confidentiality and intellectual property handled?
Do not include any proprietary or confidential information in the Title and Executive Summary sections as they may be publicly shared if selected. The information contained within proposals is treated as confidential and all proposal reviewers sign a non-disclosure agreement when accessing the proposals. NIH retains the right to publicly share proposal summaries or abstracts; however, proprietary information will not be shared without the express written consent of the proposal submitter.
Proposals awarded under this solicitation are required to comply with all of the NIH Standard Award Terms and Conditions. Specifically, information on the management of intellectual property can be found in Section 8.2.4 of the NIH Grants Policy Statement. In brief, the Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212; Executive Order 12591; 37 C.F.R. 401 et al; updated April 14, 2018.) is applicable to Over-the-Counter Home Use Platforms for HIV Detection and Antiretroviral Therapy Monitoring funding recipients and provides incentives to promote the utilization of inventions conceived or reduced to practice in the performance of federally supported research and development. The Bayh-Dole Act applies to all NIH research and development funding granted to for-profit organizations regardless of size and all non-profit entities.
Can applicants from outside the U.S. apply?
Applicants are required to have a permanent U.S. address in order to apply.
Can test components be manufactured outside the U.S.?
At this time there are no requirements that test supplies and components be manufactured exclusively within the U.S.
Do plans for marketing have to include the U.S.?
Yes, the primary focus of this solicitation is HIV testing platforms for the OTC domestic market. Project teams must plan to market and deploy the test within the U.S.
Does my device have to be a test for HIV? Can it be a component/reader etc.?
There is no provision for components in this solicitation. If you have a component product that you would like to develop we might suggest partnering with an assay developer and applying as a team.
Must companies have an established Limit of Detection for HIV testing to apply?
Yes. Companies must have an established LOD and must distinguish the limit of detection, limit of quantitation, and any clinical classification threshold, as applicable.
Can companies apply for more than one of the product profiles?
Yes, companies may submit multiple applications so long as each submission describes a distinct technology that fits a different product profile. Note the following exception: no organization may propose both a quantitative and semi-quantitative viral load platform.
Can companies with technologies that utilize a sample type other than whole blood apply?
Companies must apply with technologies that utilize whole blood as the starting point.
Will there be opportunities for further NIH funding based on progress in the Work Package and milestone achievements?
Contingent upon the performance of Work Packages and the technologies’ commercialization potential, NIH may consider advancing a limited number of funded projects with additional resources applied for acceleration towards market readiness and pre-clinical testing. The details of a future opportunity will be released separately.
Awards are described as total cost, does that include both the direct and indirect costs?
Yes, the budgets awarded for milestone-based Work Packages are total cost; that means it is the sum of both direct and indirect costs.
Deadline
January 15, 2027, 11:59pm Eastern Time