Quidel Granted FDA EUA for Lyra Direct SARS-CoV-2 Assay to Allow Direct Sample Processing

Quidel Corporation (San Diego, CA, USA) has received Emergency Use Authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay from the Food and Drug Administration (FDA) to allow direct sample processing.

Under the new EUA, the Lyra Direct SARS-CoV-2 Assay no longer requires an up-front sample extraction. The Lyra 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. The assay retains its versatility in that it is capable of running on any of seven possible thermocyclers (Applied Biosystems 7500 Standard, Applied Biosystems 7500 Fast, Bio-Rad CFX96 Touch, Qiagen Rotor-Gene Q, Roche LightCycler 480, Roche Cobas z480, and Thermo Fisher QuantStudio 7 Pro).


Separately, the Lyra Direct SARS-CoV-2 Assay received CE Mark on May 8, 2020. The CE Mark allows Quidel to market and sell the Lyra Direct SARS-CoV-2 Assay in Europe, as well as other countries that accept the CE Mark. The assay is currently available for sale in the US under EUA.