Illumina’s COVID-19 Test is First NGS-Based Diagnostic to Garner EUA from FDA

Photo: Illumina

Sequencing technology giant Illumina announced Wednesday that it received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Illumina COVIDSeq Test. The IVD workflow of Illumina’s diagnostic will allow labs to scale up testing to meet what is expected to be increased demand for COVID-19 diagnostics.

“COVIDSeq leverages the performance of NGS to help address the global need for diagnostic testing to fight the COVID-19 pandemic,” said Francis deSouza, Illumina’s CEO in a press release. “Beyond diagnostic testing, Illumina and a number of our customers are exploring NGS-based workflows to enable high-volume screening to support a return to work and school.”

COVIDSeq, run on the company’s NovaSeq 6000 system, will deliver test results within 24 using upper respiratory tract specimens from both nasopharyngeal or oropharyngeal swabs. The test includes 98 amplicons targeting the full SARS-CoV-2 genome. Significantly, the company will use its S4 flow cell for the tests providing a workflow that can process up to 3,072 samples per run on the NovaSeq 6000. The workflow uses the company’s Tagementation library prep with fast analysis and reporting provided by DRAGEN, which Illumina acquired via its purchase of Edico Genome in 2017.

The test has not received a formal clearance or approval from the FDA, but like all the roughly 100 COVID-19 diagnostics that have received and EUA, it is authorized for use for the as long as the FDA determines the emergency use of diagnostics is warranted during the pandemic. Further, the test is only authorized for use in labs that CLIA-certified to perform moderate- and high-complexity testing.

Illumina has made the test available to a limited number of early access testing sites, with broader distribution expected later this summer.

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