On Mar. 17, 2020, Quidel Corp. announced it had received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Lyra SARS-CoV-2 Assay, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19 by their healthcare provider.

Testing was limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. – 263a, to perform high complexity tests. EUAs allow for the early availability of important diagnostic tools ‘when there are no adequate, approved and available alternatives.’