RADx High Performance Tests - RADx Tech High Performance Tests
High-Performance COVID-19 Rapid Tests
Fast-Track Program to Advance U.S. COVID-19 Testing Capabilities
The RADx Coordination Center at CIMIT, on behalf of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) of the National Institutes of Health (NIH), is soliciting proposals to further advance next-generation (next-gen) over-the-counter (OTC) and point-of-care (POC) testing technologies for COVID-19 under its Rapid Acceleration of Diagnostics (RADx) fast-track program.
Under this RADx Tech Performance solicitation, NIBIB is seeking to accelerate the development of next Next-Gen COVID-19 diagnostic technologies with a focus on performance innovations: Innovations that provide significantly improved clinical and technical performance compared to current, best-in-class OTC/POC technologies. These platforms must also integrate universal design features in order to ensure the broadest possible ease of use and accessibility for all populations. Test platforms should return results quickly, demonstrate potential for integration with digital health reporting standards, and be capable of achieving regulatory clearance during both pandemic and non-pandemic periods.
The availability of OTC and POC COVID-19 tests has greatly assisted the nation in dealing with the SARS-CoV-2 pandemic. However, the SARS-CoV-2 virus has continued to evolve, spreading and mutating into new variants. The emergence of these variants can potentially impact test performance, depending on the type and design of the tests and the prevalence of the variants circulating in the population. Serial testing over multiple days has been recommended for tests currently on the market to maximize performance in infected populations. Further benefit could be gained from OTC/POC tests with higher performance that approaches or exceeds the level of lab-based tests.
Therefore, NIBIB is seeking to accelerate the development of Next-Gen COVID-19 diagnostic technologies with significantly improved performance and features compared to current widely available platforms. Tests with superior analytical, technical, and clinical performance in terms of absolute detection limits (e.g. genome copies per mL, moles of proteins), variant agnostic capabilities, and real-world clinically significant and relevant performance are needed to improve convenience, reduce time to result, and minimize if not eliminate the need for serial testing.
RADx has assembled a national network of expert technical, clinical, business, manufacturing, and regulatory advisors who will provide individualized assistance for funded projects. 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 commercialization of projects that meet milestones. 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 with RADx support toward FDA approval and widespread use.
Submissions will follow a multi-stage process:
Stage: Rolling Review
Scope of Work: Project proposals will be accepted and reviewed through the online RADx Tech portal beginning on September 20, 2022. 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. NIBIB will make the final determination about which proposals will advance to the “Deep Dive” stage for work package development based on review criteria and competitiveness of the proposal.
Stage: Deep Dive - Work Package Development
Scope of Work: Following the Review, projects selected for further consideration by RADx Tech will be assigned a team of commercialization and subject matter experts to do a Deep Dive into the project with the applicant team. The Deep Dive will identify key risk factors that may impede the deployment of the proposed solution, as well as clear milestones that address these risks. During the Deep Dive, a group of experts will help identify additional resources needed to accelerate the project, including partnerships and/or collaborations with other applicants and/or outside organizations as appropriate. The output of the Deep Dive will be a proposal for two Work Packages (Work Package #1 and Work Package #2).
The proposed Work Packages will be reviewed by an external panel of experts for technical, clinical, regulatory, and commercialization feasibility based on the Project Review Criteria stated below. NIBIB will make the final determination about which proposals will advance to the Work Package implementation stage, with approved work beginning as soon as possible.
The proposed Work Packages will cover the full range of activities needed to re-risk, develop, verify, and validate the solution and to be ready for FDA regulatory review, manufacturing, and commercialization.
Stage: Work Package #1 - De-risking
Scope of Work: Work Package #1 is intended to address high-risk barriers to success which, when successfully resolved, will enable Work Package #2 which will focus on implementation. Project teams will work to meet the established milestones, aimed toward demonstrating that the solution is feasible within an accelerated timeframe.
The RADx Tech Deep Dive team will continue to support project teams during Work Package #1, and NIBIB and RADx Tech will provide milestone-driven financial and in-kind resources to maximally accelerate progress. NIBIB will closely monitor progress during Work Package #1, assess milestone achievements, determine if any adjustments are warranted, and evaluate the need for continued funding based on the achievement of milestones.
Stage: Work Package #2 - Implementation
Scope of Work: Work Package #2 will cover the full range of activities needed to be ready for FDA regulatory authorization, manufacturing, and commercialization. Funding for Work Package #2 will be contingent on meeting the milestones of Work Package #1, having a well-resourced commercialization plan, and the market competitiveness of the solution as assessed by the NIBIB.
The RADx Tech Deep Dive team will continue to support project teams during Work Package #2, and NIBIB and RADx Tech will provide milestone-driven financial and in-kind resources to maximally accelerate progress. NIBIB will closely monitor progress during Work Package #2, assess milestone achievements, determine if any adjustments are warranted, and evaluate the need for continued funding.
Budgets for this phase of the work are expected to be substantial. NIBIB will supply funding, partnerships, and in-kind resources needed for the solution to be ready for regulatory authorization, manufacturing, and commercialization. NIBIB will negotiate cost sharing with for-profit institutions as appropriate.
Project Review Criteria
Each application will be reviewed by an independent external expert panel. All applications must:
- Clearly describe how the proposed technology will significantly improve clinical and technical performance compared to current, best-in-class OTC/POC technologies.
Integrate universal design features for the broadest possible ease-of-use and accessibility for all populations
Applications must provide details on how performance in terms of absolute detection limits (e.g. genome copies per mL, moles of proteins), variant agnostic capabilities, and real-world clinically significant and relevant results will be accomplished and verified.
Additional factors that should be addressed and will be considered:
- Time to commercialization readiness and ability to meet regulatory requirements for intended use (OTC and/or POC): submissions for EUA within 24 to 36 months and standard clearance within 24 months
- Innovations that can potentially reduce manufacturing costs and retail prices, facilitate rapid scale-up during surge demands, and improve supply chain resilience
- Support for digital health platforms including ability to communicate results to appropriate healthcare providers and, as appropriate or required, public health authorities
- Ability to work with/adapt to rapidly changing variants and be multiplexed and/or adapted for multiple pathogens/diseases
- Experience, resources, and commitment of the team and applicant organization
There will be a rolling submission and selection period beginning on September 20, 2022 that is currently planned to continue until October 14, 2022.
Proposals submitted to RADx Tech will be reviewed rapidly as applications are received (see Project Review Criteria). Based on meritorious review, RADx Tech will select projects for a multi-phase process described above. Each phase will have a separate funded budget and deliverables that must be reached to move to the next phase. Successful completion of a phase does not guarantee funding for the next phase as this is a competitive program with limited funds.
Awards are milestone-based and selected teams must work collaboratively with assigned RADx experts and associated web-based tools, including the CIMIT's GAITS platform to continue. Full Federal overhead rates apply.
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