RADx Tech II: Fast-Track Program to Advance U.S. COVID-19 Testing Capabilities
Overview
The application period has passed for this program.
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is announcing its Point-of-Care Technology Research Network (POCTRN) is soliciting proposals to further advance SARS-CoV-2 testing technologies in order to fill specific unmet national needs. Rapid Acceleration of Diagnostics (RADx), is a fast-track program that leverages the POCTRN. This solicitation will only consider proposals for technologies in an advanced stage of readiness that can reach the market in 2021.
Under this RADx Tech II solicitation, NIBIB is seeking proposalsto accelerate validation, manufacturing scale up, and commercialization of innovativeCOVID-19 testing capabilities in the following areas:
Innovative, cost-effective, and accessible home and point-of-care (POC) technologies that fill unmet national needs for screening, surveillance, diagnosis, and prognosis. Examples include:
Home and POC testing technologies with analytical performance features (such as limit of detection (LOD)) that are comparable or superior to lab-based tests.
Home and POC multiplexed tests that can detect SARS-CoV-2 in combination with other respiratory pathogens.
Home and POC tests optimized for sample pooling and rapid reporting of small groups, with analytical performance comparable to high complexity lab PCR pooling.
Home and POC tests with optimized design, performance, and sample collection for the pediatric population.
Home and POC tests employing innovative sampling methods and/or signatures of SARS-CoV-2 infection.
Innovative methods and technologies that can be deployed in any setting (Lab, POC, home) that significantly advance SARS-CoV-2 variant testing capabilities. Examples include:
Home, POC, and lab platforms that can be rapidly configured and deployed for screening and surveillance of specific SARS-CoV-2 mutations of biological significance (variants).
Innovative NGS and other technologies capable of rapid, cost-effective variant identification with improved workflows and performance over current solutions.
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 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 successfully 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 by RADx into widespread use.
Submissions will follow a three-stage process:
Stage
Scope of Work
Rolling Review
Project proposals will be accepted and reviewed through the online RADx portal on a rolling basis. 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 review criteria and potential for rapid commercialization.
Deep Dive: Work Package Development
Following review, projects selected for consideration by RADx Tech II will be assigned a team of healthcare commercialization and subject matter experts to do a “deep dive” into the project with the applicants. Depending on the maturity 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 the project.
The product of this planning will be a work package for accelerated commercialization of the product under a confidential contract from NIH.
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. NIH will make the final determination about which proposals will advance to the work package stage, with approved work beginning as soon as possible.
Work Package Implementation
The work package will cover the full range of activities needed to validate, scale up manufacturing, commercialize, and distribute a best-in-class product to the public.
The RADxexpert 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 the work package, assess milestone achievements, and evaluate the need for continued funding.
Budgets for this phase of the work are expected to be substantial. Budgets may include funding for validation and manufacturing scale-up to enable distribution by the end of 2021 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.
Project Review Criteria
Each application will be reviewed by an independent external expert panel to assess the potential of the proposed solution to meet each of the following criteria.
The technology fulfills an unmet national testing need (as described above).
The technology is at an advanced stage of development (at least at Design Freeze) for the product to be manufactured.
Established Quality Management System appropriately reflecting current state of development with plans to establish complete QMS if not currently completed.
Product performance has been verified on the design frozen product (not a substitute product or process), preferably with clinical samples.
Established plan for production including forecasts, timeline, milestones, supply chain needs, product cost, and other ramp up considerations.
Key commercial partners, contractors, vendors, and service providers secured.
Receipt or submission of FDA EUA or preEUA (as appropriate/needed for product type; note that not all products require an EUA).
Establishment of clinical studies plan (as appropriate/needed for product type).
Demonstrates ability to manage any relevant supply chain shortages with multiple contingencies.
Ability to serve/deploy to high-risk, underserved, hard-to-reach communities.
Preliminary CLIA classification by FDA and/or regulatory expert.
Timeline
There will be a rolling submission and selection process beginning June 7, 2021 that is currently planned to continue until June 28, 2021, 11:59pm ET.
Award Information
Proposals submitted to RADx Tech II will be reviewed rapidly on a rolling basis (see Project Review Criteria). Based on meritorious review, RADx Tech II will select projects for a 2-phase process (Deep Dive, Work Package Implementation).
Deep Dive: 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 a “deep dive” with content and commercialization experts that produces a customized work package. Based on the results of this deep dive, a subset of projects will be selected for progression to work package implementation.
Work Package Implementation. The awarded milestone-driven budget will be sufficient to enable full product commercialization 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.
The application period has passed for this program.
