Illumina (NSDQ:ILMN) announced that it received FDA emergency use authorization (EUA) for its COVIDSeq sequencing-based COVID-19 diagnostic test.
COVIDSeq uses upper respiratory specimens, such as a nasopharyngeal or oropharyngeal swab, and delivers sample receipt to result in 24 hours with the NovaSeq 6000 sequencing system, according to a news release.
Illumina’s high-throughput, in vitro diagnostic test includes 98 amplicons that target the full SARS-CoV-2 genome to create accurate detection and high sensitivity. The workflow accommodates up to 3,072 samples per NovaSeq run, leveraging the S4 flow cell, and it includes steps for viral RNA extraction, RNA-to-CDNA conversion, PCR, library preparation, sequencing and report generation.
COVIDSeq is currently available to a limited number of early access sites as Illumina expects the test to be more widely available this summer.
“COVIDSeq leverages the performance of NGS to help address the global need for diagnostic testing to fight the COVID-19 pandemic,” Illumina CEO Francis deSouza said in the news 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.”