ATP - POCTRN

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
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For more information about the application process, review criteria, timeline, and award information please visit this page.