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Quidel Extractionless COVID PCR Test Get FDA Emergency Use Authorization

NEW YORK – An assay from Quidel to detect SARS-CoV-2 without an upfront nucleic acid extraction step was granted Emergency Use Authorization from the US Food and Drug Administration on Monday. The firm has also received the CE mark for the assay.

The Quidel Lyra Direct SARS-CoV-2 assay uses a reformulated buffer and replaces the extraction step with a 10-minute heating step. This, the firm noted in a statement, can potentially relieve an ongoing bottleneck on sample extraction kits and can save 50 minutes of processing time.

The Lyra Direct runs on any of seven thermal cyclers, including the Applied Biosystems 7500 Standard and 7500 Fast, Bio-Rad CFX96 Touch, Qiagen Rotor-Gene Q, Roche LightCycler 480 and Cobas z480, and Thermo Fisher QuantStudio 7 Pro.

The Lyra Direct SARS-CoV-2 Assay also received the CE mark on May 8, Quidel said.

The assay is currently available for sale in the United States under EUA and can be purchased through Quidel directly or through Cardinal Health.