On Apr. 22, 2020, Quidel announced it has applied for an Emergency Use Authorization (EUA) for the Lyraﾮ Direct SARS-CoV-2 Assay from the FDA to allow direct sample processing. The assay will be run on the same six different instruments as the Lyra SARS-CoV-2 Assay.

Under the new EUA, the Lyra Direct SARS-CoV-2 Assay no longer requires an upfront sample extraction. The Lyraﾮ Direct SARS-CoV-2 Assay uses a reformulated buffer that replaces the extraction step with a simple 10-minute heat step, saving approximately 50 minutes in processing time.