NIH and POCTRN have suspended the RADx Fast-Track Program for COVID-19 Test Development and Distribution submission portal and are currently not accepting new applications. Those who have previously submitted complete applications that meet the eligibility criteria will be reviewed. If additional resources to support the RADx program become available, NIH and POCTRN may re-evaluate this decision and could consider accepting applications once again. In the meantime, those interested in the RADx program are encouraged to pursue other funding opportunities offered by NIH listed here.

RADx Advanced Technology Platforms (RADx-ATP)

The RADx-ATP program seeks to increase testing capacity and throughput by identifying existing and late stage testing platforms for COVID-19 that are far enough advanced to achieve rapid scale-up or expanded geographical placement in a short amount of time. These efforts will focus on scaling up technologies, including improving existing high-throughput platforms, to increase performance.

Specific project examples include:

  • Scale up of existing technologies that are already or near FDA authorization for SARS-CoV-2 detection. Some emphasis will be placed on differential testing to distinguish SARS-CoV-2 vs. Influenza virus detection
  • Establish or expand regional testing hubs, to validate and perform clinical tests. This could also be supportive of identifying needs for facilities to expand testing in underserved populations
  • Accelerating the development and implementation of tests for multiple infectious diseases, including viruses and the immune response, bacteria, and genetics

POC Company and Test Requirements

  • Has capacity to scale production to between 20,000 and 100,000 tests per day by September 2020
  • Has received FDA EUA for SARS-CoV-2 (or will received by time of award)
  • Demonstrates a minimum of 90% sensitivity and 95% specificity, preference will be given to tests with highest clinical performance
  • Has infrastructure and deployment/placement strategy in place to rapidly deploy tests to Point-of-Care settings
  • Demonstrates ability to manage any relevant supply chain shortages
  • Has existing or planned capability for using FHIR-based APIs for standardized electronic data transmission
  • Has ability to test concurrently for Influenza A&B but is not a requirement
  • Has ability to deploy to high-risk, underserved, hard-to-reach communities, with special focus on ease-of-use (including specimen collection mode, clear and easy to understand instructions to facilitate widespread uptake)
  • Has robust plan to continuously collect post-market data to support a PMA/510(k) submission, share data with NIH, update clinical validity measures, monitor differences in test results by type of specimen, collection device, user, setting, and other variables that may impact test results.
  • Cost per test must be competitive with the current market price

High-throughput Laboratory Requirements

  • Is a high-throughput laboratory able to process between 100,000-250,000 tests per day
  • System can be expanded to at least 100,000 tests per day by September 2020
  • Laboratory is CLIA certified and currently operating with appropriate equipment and trained staff
  • Uses SARS-Cov-2 test with FDA EUA (or will have EUA near the time of award) with a minimum of 95% sensitivity and 95% specificity. Preference will be given to tests with highest clinical performance
  • Turn around time within 24 hours of receiving the sample
  • Uses commercially available laboratory equipment and re-agents, and has plan to address any supply chain shortage issues
  • Has established automated and reproducible workflows for managing at least 100,000 tests by day
  • Has logistics plan in place for the collection and receipt of samples (e.g. has identified appropriate courier services to deliver samples)
  • System is reproducible to other laboratories and willing to consider expanding to other geographical areas through tech transfers
  • Is prepared to provide evidence of current operation (full plans, Standard Operating Procedures (SOPs), scripts for automation, and other documentation on sample collection practices  etc.)
  • Has existing or planned capability for using FHIR-based APIs for standardized electronic data transmission
  • Cost per test must be competitive with the current market price
For more information about the application process, review criteria, timeline, and award information please visit this page.