RAPID ACCELERATION OF DIAGNOTICS (RADX) ADVANCED TECHNOLOGIES PLATFORM RAPID ACCELERATION OF DIAGNOTICS (RADX) ADVANCED TECHNOLOGIES PLATFORM PROJECT

To enable reopening and monitoring of industrial, educational, and public sectors, widespread diagnostic testing for SARS-CoV-2 is needed. Rapid scale up is required to meet the testing needs in the US. Helix OPCO, LLC will establish an FDA-approved polymerase chain reaction (PCR) SARS-CoV-2 test, under Emergency Use Authorization (EUA), and perform testing in a CLIA-certified laboratory. Testing capacity will be incrementally scaled up to establish a high-throughput laboratory capable of daily processing of 25k, then 50k, then 100k, and finally 150k PCR tests with processing and analysis completed within a day of sample receipt. A subset of samples will undergo full viral genome sequencing, with sequences uploaded to GISAID and other public databases. Characterized samples will be provided to the RADx Variants Task Force to ensure that testing technologies are capable of detecting the full spread of SARS-CoV-2 variants. Expanded testing capacity through an FDA EUA method will support the needs of the US to monitor viral spread, detect variants, and inform reopening and mitigation efforts