FDA grants first EUA for COVID next-generation sequencing
The US Food and Drug Administration (FDA) has issued the first emergency use authorization to Illumina for a sequencing-based in vitro diagnostic test to detect SARS-CoV-2, the virus that causes COVID-19.“Having a next generation sequencing diagnostic tool available will continue to expand our testing capabilities. Additionally, genetic sequencing information will help us monitor if and how the virus mutates, which will be crucial to our efforts to continue to learn and fight this virus,” said FDA Commissioner Steven Hahn.
The qualitative next-generation sequencing (NGS) test can use nasopharyngeal or oropharyngeal swabs as well as aspirates and bronchoalveolar lavage specimens. Only laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests may employ the new COVIDSeq Test.
The viral genomic information the newly authorized test provides can be used by researchers to track change over time and across geography in the SARS-CoV-2 virus, aiding public health officials and researchers in their understanding of the virus and the pandemic.
The high-throughput workflow can process up to 3,072 samples per sequencing run, according to a press release from Illumina.
“COVIDSeq leverages the performance of NGS to help address the global need for diagnostic testing to fight the COVID-19 pandemic,” said Francis deSouza. “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.”