March 31, 2020—Quidel’s Lyra SARS-CoV-2 Assay has received expanded emergency use authorization claims from the FDA to allow testing with three additional thermocyclers: Applied Biosystems 7500 Standard, Roche LightCycler 480, and Qiagen Rotor-Gene Q. Under the initial EUA, the Lyra SARS-CoV-2 Assay real-time RT-PCR test was intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens. The list of acceptable specimens has been expanded by the Centers for Disease Control and Prevention to include nasal and nasal turbinate swabs.
Separately, the Lyra SARS-CoV-2 Assay received on March 25 the CE mark and also authorization from Health Canada to market and sell the assay in Canada.