www.fdanews.com/articles/197570-illumina-gets-emergency-use-authorization-for-sequencing-based-covid-19-test
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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.