Quidel’s Lyra SARS-CoV-2 Assay Receives the US FDA’s Expanded Emergency Use Authorization for Molecular Detection of COVID-19

Shots:

• Quidel’s Lyra SARS-CoV-2 Assay has received expanded FDA’s EUA 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 was intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal/ oropharyngeal swab specimens from suspected COVID-19 patients
• Additionally, the Lyra SARS-CoV-2 assay has received the CE-Mark and Health Canada’s authorization which allows it to launch in the EU and Canada respectively. The assay is currently available in the US under the EUA

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