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.’

Quidel serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system.