FAQs - POCTRN
Advanced Platforms for HIV Viral Load Testing at the Point-of-Care General FAQs
What is the purpose of the Advanced Platforms for HIV Viral Load Testing at the Point-of-Care solicitation?
There is a significant unmet need across the U.S. and globally to provide viral load testing at the point-of-care with technology that is sufficiently sensitive and simple to use. This would allow clinicians to easily monitor responses to antiretroviral therapy among people living with HIV at convenient locations.
The Point-of-Care Technology Research Network (POCTRN) is soliciting proposals to further advance HIV viral load detection technologies in order to fill specific unmet national and global needs. Under this solicitation, NIBIB is seeking proposals to accelerate the validation and prototyping of innovative HIV viral load testing technologies that are designed for use at the point-of-care that fill unmet national and global needs with a high level of analytical performance, especially for detecting low levels of virus, that facilitates monitoring people living with HIV taking ART and accurately assessing its effectiveness. Proposed solutions with optimized design, performance, and sample collection for infants are welcome but not required, as are technologies that employ innovative sampling methods.
When can proposals be submitted?
Proposals may be submitted until 11:59 PM ET December 1, 2022. It is anticipated that proposal review will occur in January 2023 with one or more awards being made 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 support. Projects will be closely monitored for progress and future support will be dependent upon achieving stated milestones.
Is the goal of the program to facilitate clearance of HIV viral load point-of-care tests by the U.S. Food and Drug Administration (FDA)?
No, budgets should cover the costs of technology validation and prototyping. Under this solicitation, NIBIB is seeking proposals to accelerate the validation and prototyping of innovative HIV viral load testing technologies that are designed for use at the point-of-care that fill unmet national and global needs with a level of analytical performance, especially for viral load limit of detection, that facilitates monitoring people living with HIV on antiretroviral therapy and accurately assessing infectiveness.
Is obtaining FDA clearance necessary before the test can be deployed?
Yes. FDA clearance is required for viral load tests to be marketed in the U.S. However, obtaining clearance is not a goal or requirement of this solicitation.
How are confidentiality and intellectual property handled?
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 awarded proposals 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?
Yes, applicants from all geographic locations are encouraged to apply.
Can diagnostic 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, project teams must plan to market and deploy the test within the U.S.
Does my device have to be a diagnostic test for HIV viral load? Can it be a component/reader etc.?
There is no provision for components in this solicitation. If you have a component product that you’d like to develop, we suggest partnering with an assay developer and applying as a team.
Can companies that have not established a limit of detection for their HIV viral load testing technology apply?
Yes. It is not required that companies know the limit of detection of their HIV viral load testing technology when they apply.
Can companies with technologies that utilize a sample type other than whole blood or plasma apply?
No. Applications using other sample types will not be considered.