RADx - POCTRN
Fast-Track Program for COVID-19 Test Development and Distribution
Innovative Technologies to Increase U.S. Capacity for COVID-19 Testing
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is urgently soliciting proposals and can provide up to $500M across multiple projects to rapidly produce innovative SARS-CoV-2 diagnostic tests that will assist the public’s safe return to normal activities. Rapid Acceleration of Diagnostics (RADx), is a fast-track technology development program that leverages the National Institutes of Health (NIH) Point-of-Care Technology Research Network (POCTRN). RADx will support novel solutions that build the U.S. capacity for SARS-CoV-2 testing up to 100-fold above what is achievable with standard approaches. RADx is structured to deliver innovative testing strategies to the public as soon as late summer 2020 and is an accelerated and comprehensive multi-pronged effort by NIH to make SARS-CoV-2 testing readily available to every American.
NIBIB is providing substantial support to accelerate the development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can directly detect SARS-CoV-2, the virus that causes COVID-19. NIBIB will support the full range of product development including commercialization and product distribution.
To address the COVID-19 pandemic as quickly as possible, NIBIB is mobilizing and expanding the focus of POCTRN to encompass both point-of-care and more traditional laboratory-based approaches. NIBIB will consider innovations at all stages of readiness to circumvent current limitations to SARS-CoV-2 testing capacity, including:
- Early stage: transformative innovations based on novel testing strategies that have potential for major scale up
- Advanced stage (RADx ATP): modification and optimization of existing SARS-CoV-2 testing approaches, including clinical laboratory tests, that can dramatically increase testing capacity
Design features might include technical innovations that:
- Improve analytical performance, e.g., sensitivity, specificity, dynamic range, limit of detection, reliability, accuracy, speed (time to test result) and throughput
- Enhance operational performance through, e.g., development of a patient- and user-friendly design, use of alternative sampling strategies (e.g., saliva, exhaled breath), integration with mobile-devices, designs for home-based use or strategies to overcome bottlenecks with current testing approaches
- Improve access and reduce the cost of testing
RADx will provide resources to support all phases of the product development pipeline from conceptualization and design to reduction-to-practice, performance evaluation, clinical validation, and scale-up of manufacturing.
To meet the accelerated timelines, RADx has assembled a national network of expert technical, clinical, manufacturing, and regulatory advisors who will provide individualized assistance for project development and commercialization. Funding for projects selected for this program will be dependent on successfully meeting aggressive project milestones. NIBIB will provide financial and in-kind support to accelerate the entire product life-cycle, from design to market, for projects that meet milestones successfully. To ensure that innovations are available to the public as quickly as possible, NIH will leverage established partnerships with federal agencies, such as FDA, CDC, CMS, and ASPR/BARDA, as well as commercial and private entities to propel technologies developed by RADx into widespread use.
The RADx fast-track program is structured to provide escalating support to awardees in a stage-gated manner, though advanced programs can progress more quickly:
Scope of Work
Project proposals will be accepted through the online RADx portal on a rolling basis and will be reviewed within a week of receipt. Proposals will be reviewed by an external panel of experts for technical, clinical, regulatory, and commercialization feasibility based on the Project Review Criteria stated below. NIH will make the final determination about which proposals will advance to the “deep dive” stage for work package development based on potential for rapid development and commercialization.
Phase 0: Work Package Development
Following review, projects selected for consideration by RADx will be immediately assigned a team of healthcare commercialization and content experts to do a “deep dive” into the project with the applicants. Depending on the stage of the proposed project, this fast turn-around process will take from a few days to two weeks. The deep dive will identify key risk factors that may impede the rapid deployment of the proposed solution, as well as clear milestones that address these risks. In addition, the team will identify additional resources needed to accelerate success of the project.
Once work packages are developed, NIH will rapidly review the plan so that approved work can begin without interruption.
The work package development effort will proceed in parallel with budget negotiations to fund the work package under confidentiality terms.
Reasonable funds will be provided to the awardee to cover the costs of work package development.
Phase 1: Work Package #1 Implementation
Work package 1 is intended to address high-risk barriers to success which, when successfully resolved, will unlock the next phase of the process. Project teams will work to meet the established milestones, aimed toward demonstrating that the solution is feasible within the very accelerated timeframe: RADx intends to deploy solutions to the public as early as late summer 2020 and to bring earlier stage technologies to bear in the following months.
In addition to financial resources, project teams will be provided with expert advisors and in-kind technical, clinical, and business support to accelerate milestone success. The expectation is that work package 1 will encompass approximately 4 weeks with a budget that fully supports maximal acceleration of progress. Funding will be provided immediately to allow work to begin. Depending on the structure of the work package, some funding may be dependent on successful achievement of interim milestones.
Funding for Phase 2 (work package 2) will be contingent on meeting the milestones of work package 1 and on the continued national need for testing. It is not expected that all projects will meet milestones and have the opportunity to move forward to phase 2.
Phase 2: Work Package #2 Implementation
Work package 2 will be implemented for projects at an advanced stage of readiness and will cover the full range of activities needed to distribute a viable product to the public. As appropriate to the stage of project readiness at the time of submission, projects may enter the fast-track program directly at phase 2 or reach phase 2 by successful completion of phase 1 milestones. Results of work conducted on a project during phase 1 may necessitate changes to work package 2 at this stage. Changes will be negotiated with the awardee, including budget and milestones for advancing through phase 2 toward commercialization. NIH will rapidly review work package 2 for approval.
The RADx expert consulting team will continue to support successful projects, and NIBIB and RADx will provide milestone-driven financial and in-kind resources to maximally accelerate progress. NIH will closely monitor progress in work package 2, assess milestone achievements, and evaluate the need for continued funding.
Budgets for this second phase of the work are expected to be substantial. Budgets will include funding for scale-up and manufacturing to enable large-scale distribution by late summer 2020 or as early as feasible for the proposed solution. NIH will supply the needed budget, partnerships and other resources to fully deploy successful tests to the public on the shortest possible timeline. NIH will negotiate cost sharing with for-profit institutions as appropriate.
Instructions for submitting a proposal, eligibility criteria, and contact information can be found below:
Project Review Criteria
Each application will be reviewed by an external expert panel to assess the potential of the proposed solution to meet each of the following criteria by late summer, 2020 or soon thereafter:
- Technical: Can the technology be developed to the highest levels of analytical performance (e.g., sensitivity, specificity, dynamic range, limit of detection, reliability, accuracy, speed and throughput) as well as operational performance, such as patient- and user-friendly design, alternative sampling strategies (saliva, exhaled breath, etc.), optimization of swab materials and test reagents, mobile-device integration, increased accessibility and home-based use? Do these technical/design advances reduce barriers to expanding national testing capacity and provide clear advantages over current approaches?
- Clinical: Does the proposal provide a realistic approach to increasing SARS-CoV-2 testing in a way that can be rapidly integrated into and adopted by the healthcare system?
- Commercial: Assuming the technology works as anticipated, can it be implemented and made available/manufactured at scale in an economically viable way?
- Regulatory: Are there feasible plans to perform the studies required to obtain FDA Emergency Use Authorization (EUA) and to subsequently obtain FDA clearance?
There will be a rolling submission and selection process beginning April 29, 2020 that will continue until further notice.
Proposals submitted to RADx will be reviewed rapidly on a rolling basis (see Project Review Criteria). Based on meritorious review, RADx will select projects for a 3-phase process (Phases 0, 1 and 2). Advanced technology proposals selected by RADx may be considered for entry directly from phase 0 into phase 2. Each phase will have a budget and deliverables that must be reached to move to the next phase.
- Phase 0: Work Package Development. An external expert panel will rapidly review all project proposals submitted to RADx for program suitability and technology readiness level. Following review, if NIH accepts a project into the RADx program, project teams will initiate Phase 0, a “deep dive” with content and commercialization experts that produces a customized one- or two-phase work package. Awards of up to $25,000 will be provided to cover the approximately one week participation in the RADx deep dive. Based on the results of this deep dive, a subset of projects will be selected for progression to Phase 1. More advanced approaches with higher technology readiness levels will be selected for acceleration directly to Phase 2.
- Phase 1: Work Package #1. Once NIH approves a project for entry into phase 1, funding will be provided immediately to allow work to begin. Depending on the structure of the work package, some funding may be dependent on successful achievement of interim milestones. The awarded budget will be sufficient to address gating risks identified in Phase 0 on a maximally accelerated timetable. In-kind support may be provided in technical, clinical, manufacturing, and regulatory domains. Depending on the milestones that must be met, project budgets are expected to range from $500,000 to millions of dollars.
- Phase 2: Work Package #2. The awarded milestone-driven budget will be sufficient to enable full product deployment on a maximally accelerated timeline. Additional accelerating resources will be made available through partnerships established by NIH and in-kind support provided by NIH and RADx. For projects that meet all milestones toward product distribution, budgets of tens of millions of dollars are anticipated. NIH will negotiate cost sharing with for-profit institutions as appropriate.
Awards are milestone-based and selected teams must work collaboratively with assigned RADx experts and associated web-based tools, including the POCTRN Coordinating Center’s GAITS platform to continue. Full Federal overhead rates apply.
FAQs about this program can be found here.
For other programmatic or technical questions please contact firstname.lastname@example.org.