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