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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.

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