Illumina Announces FDA Emergency Use Authorization for COVIDSeq, Its NGS-Based Diagnostic Test for SARS-CoV-2

Recently, Illumina announced that the United StatesFDAEmergency Use Authorization (EUA) was granted for the COVIDSeq test developed by the company. This is a high-throughput, next-generation sequencing (NGS)-based test for SARS-CoV-2.In Vitro Diagnostics(IVD) workflow. The press release stated that this is the firstFDAEmergency Use Authorization for NGS-Based SARS-CoV-2DiagnosisDetection.

COVIDSeq utilizes upper respiratory tract samples, including nasopharyngeal or oropharyngeal swabs, and employs the NovaSeq 6000 sequencing system to deliver results within 24 hours of sample receipt. ThisDiagnosisThe assay includes 98 amplicons targeting the entire genome of SARS-CoV-2, offering high precision and sensitivity.

“COVIDSeq leverages the power of NGS to help address the global demand for diagnostic testing in the fight against the COVID-19 pandemic,” said Francis deSouza, CEO of Illumina. “In addition to developingDiagnosisTest, Illumina and many of our customers are exploring NGS-based workflows to enable high-throughput screening, supporting the return to workplaces and schools.

NGS-based SARS-CoV-2 detection methods can not only be used forDiagnosisand screening for SARS-CoV-2 infection, and because it can read the genomic sequence of SARS-CoV-2, it may provide valuable information in detecting genetic mutations of SARS-CoV-2 and monitoring viral evolution. (BioValleyBioon.com）