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Illumina Wins FDA Authorization for Sequencing-Based COVID-19 Test

By Keith Speights – Jun 10, 2020 at 11:49AM

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COVIDSeq is the first COVID-19 diagnostic test based on gene sequencing to receive a green light from the regulator.

Illumina (ILMN -3.29%) announced Tuesday evening that the Food and Drug Administration had granted an Emergency Use Authorization (EUA) for COVIDSeq, a test that uses next-generation sequencing to detect SARS-CoV-2, the coronavirus that causes COVID-19

The FDA has thus far issued more than 90 EUAs for in vitro diagnostic tests for COVID-19. But Illumina's COVIDSeq is the first COVID-19 diagnostic based on gene sequencing to receive such authorization.

DNA helix with coronavirus

Image source: Getty Images.

Like other COVID-19 tests, COVIDSeq uses samples taken from the nose or throat using swabs. The test runs on Illumina's NovaSeq 6000 sequencing system. Results can be returned within 24 hours from sample receipt with highly accurate detection and sensitivity.

COVIDSeq is currently only available to a limited number of labs, but Illumina expects it will be distributed to a wider group of labs this summer. CEO Francis deSouza stated that the company and several of its customers are exploring the potential to use next-generation sequencing in high-volume screening to support individuals returning to work and school.

Keith Speights owns shares of Illumina. The Motley Fool owns shares of and recommends Illumina. The Motley Fool has a disclosure policy.

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