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POCTRN – Fast-Track Program for COVID-19

Research Admin Offices:

  • ROADS
  • HRS

Funding Type:

Grant

Value:

a total of $500,000,000 is available to support multiple projects.  Funding for projects selected for this program will be dependent on successfully meeting aggressive project milestones.

Disciplines:

  • Health Sciences
  • Natural Sciences and Engineering

Deadlines:

Internal Deadline:

Continuous

Sponsor Deadline:

Continuous

Description:

Substantial support is being provided 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. The National Institute of Biomedical Imaging and Bioengineering (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.

Additional Program Information:

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:

  1. 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?
  2. 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?
  3. Commercial: Assuming the technology works as anticipated, can it be implemented and made available/manufactured at scale in an economically viable way?
  4. Regulatory: Are there feasible plans to perform the studies required to obtain FDA Emergency Use Authorization (EUA) and to subsequently obtain FDA clearance?

Eligibility:

Instructions for submitting a proposal, eligibility criteria, and contact information can be found by creating an account.

Resources:

Program website

Contact:

If you are applying from the Faculty of Health Sciences, please contact an Advisor from HRS.

For support with external non-industry funding, please contact Virginia Viscardi, Senior Advisor, ROADS.