NEW YORK – Quidel said after the close of the market on Wednesday that it has received expanded Emergency Use Authorization from the US Food and Drug Administration for the Lyra SARS-CoV-2 assay.
Under the expanded EUA, the assay can now be used with three additional thermocyclers, the Applied Biosystems 7500 Standard from Thermo Fisher Scientific, Roche's LightCycler 480, and Qiagen's Rotor-Gene Q.
Earlier this month the FDA issued an EUA for Quidel's assay for use with the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument.
The test is a real-time, RT-PCR test intended for the qualitative detection of nucleic acid of the coronavirus from specimens of patients suspected of having COVID-19.
Additionally as part of the amended EUA, the US Centers for Disease Control and Prevention has expanded the list of acceptable specimens for use with the Lyra SARS-CoV-2 assay to include nasal and nasal turbinate swabs, as well as nasopharyngeal and oropharyngeal swab specimens covered by the original EUA, Quidel said.
The San Diego-based company further said that the assay received the CE mark, allowing it to market and sell the test in Europe and other geographies that recognize the designation. Health Canada also authorized the assay for marketing and sale in that country. Both designations were received on Wednesday, Quidel said.