Fast-Track Program for COVID-19 Test Development and Distribution
Innovative Technologies to Increase U.S. Capacity for COVID-19 Testing
NIH POCTRN is now accepting proposals for support on a rolling basis until further notice.
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.
For more information: https://www.poctrn.org/radx
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