On Mar. 26, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to the Twist Bioscience for their SARS-CoV-2 NGS Assay. The SARS-CoV-2 NGS Assay was a next-generation sequencing (NGS) based test for the identification of SARS-CoV-2 RNA from respiratory samples, such as nose or throat swabs and washes, from people who are suspected of having COVID-19.

This is the second whole genome sequencing diagnostic test for the qualitative detection of SARS-CoV-2 RNA authorized by the FDA. The test can be performed in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that meet the requirements to perform high-complexity testing.

To date, 348 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 258 molecular tests and sample collection devices, 74 antibody and other immune response tests, and 16 antigen tests. There are 42 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, one over-the-counter (OTC) at-home antigen test, and one OTC molecular test.