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BioWorld - Tuesday, December 16, 2025
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Home » Quidel assay wins EUA to detect COVID-19 without extraction step
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Quidel assay wins EUA to detect COVID-19 without extraction step

May 19, 2020
By Liz Hollis
Quidel Corp., of San Diego, has scored another win at the U.S. FDA, receiving emergency use authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay to allow direct sample processing. What’s special about this assay is that it does not require an up-front sample extraction. Instead, it uses a reformulated buffer that replaces that process with a simple 10-minute heat step, saving about 50 minutes in processing time.
BioWorld MedTech Regulatory Coronavirus Diagnostics FDA

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