Advanced Platforms for HIV Viral Load Monitoring FAQs - CIMIT MAIN


null Advanced Platforms for HIV Viral Load Monitoring FAQs

Advanced Platforms for HIV Viral Load Monitoring FAQs

What is the purpose of the Advanced Platforms for HIV Viral Load Monitoring at the Point-of-Care solicitation?

According to the FY 2021-2025 NIH Strategic Plan for HIV and HIV-Related Research coordinated by the NIH Office of AIDS Research (OAR) and HIV persists as one of the world’s most serious public health, development, and economic challenges. As new acquisitions continue to affect communities and augment disparities, HIV remains a major global public health issue that requires immediate attention.

Therefore, in collaboration with the NIH OAR and National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Biomedical Imaging and Bioengineering (NIBIB) announces that its Rapid Acceleration of Diagnostics (RADx) program is soliciting proposals to further advance HIV viral load detection technologies to fill specific unmet national and global needs. Under this solicitation, NIBIB is seeking proposals to accelerate the regulatory clearance and commercialization of innovative HIV VL testing platforms 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 VL limit of detection, that facilitates monitoring ART effectiveness (i.e., viral rebound) and accurately assessing potential for transmission.

When can proposals be submitted?

Proposals may be submitted until 11:59 PM ET June 14, 2024. It is anticipated that proposal review will occur in June 2024 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. 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 viral load point- of-care tests by the U.S. Food and Drug Administration (FDA)?

Under this solicitation, NIBIB is seeking proposals to accelerate the evaluation, preparation, and readiness for future studies required for regulatory submission/clearance of innovative HIV VL testing platforms that are designed for use in the point-of-care setting.

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.

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 Advanced Platforms for HIV Viral Load Monitoring at the Point-of-Care 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 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 might suggest partnering with an assay developer and applying as a team.

Must companies have an established Limit of Detection for HIV viral load testing to apply?

Yes. Companies must have an established LOD and must describe how the technology can achieve detection limits under 1000 copies/ml.

Can companies with technologies that utilize a sample type other than whole blood or plasma apply?