Talis Biomedical Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Talis One COVID-19 Test System - a nucleic acid amplification test (NAAT). The Talis One COVID-19 test runs on an integrated system that includes a compact instrument, self-contained, single-use test cartridges and software for reporting results. Designed for use in a variety of healthcare and congregate settings, the Talis One system enables sample-to-answer molecular testing in less than 30 minutes. In a clinical study, the Talis One COVID-19 Test System demonstrated 100% concordance with the comparator test results, including both the positive and negative percent agreements. All samples were collected and tested in point-of-care settings. The Talis One COVID-19 Test System targets two genes, ORF1ab and N, to optimize sensitivity and the inclusion of variants. The ORF1ab and N gene were selected for their conserved nature and their unique sequence specific for SARS-CoV-2. Designed for cloud connectivity, the instrument is being further developed to enable easy results sharing and simplified patient data management in the future. Development of the Talis One COVID-19 Test System was supported by the NIH Rapid Acceleration of Diagnostics RADxSM initiative and has been funded in part with federal funds from National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00010.