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emergency use authorization approved

Illumina Gets Emergency Use Authorization for Sequencing-Based COVID-19 Test

June 11, 2020

Illumina has obtained the FDA’s first Emergency Use Authorization (EUA) for a sequencing-based COVID-19 diagnostic.

The EUA covers the company’s COVIDSeq test, a high-throughput, sequencing-based in vitro diagnostic that detects SARS-CoV-2 by targeting the full viral genome.

The diagnostic tests upper respiratory specimens, including nasopharyngeal or oropharyngeal swabs, and delivers results in 24 hours using the company’s NovaSeq 6000 Sequencing System.

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