SAN DIEGO — Illumina has won regulatory approval for the first COVID-19 based on next- generation gene sequencing, which could help track mutations of the virus while delivering high-volume results.
The U.S. Food and Drug Administration approved an Emergency Use Authorization on Tuesday for Ilumina’s coronavirus test. It can deliver results in 24 hours from nasal or throat swabs.
Called COVIDSeq, Illumina’s high volume test includes 98 DNA or RNA markers that target the full SARS-CoV-2 genome. The test is currently available on a limited basis but will become more broadly available this summer.
About 125 molecular and other types of tests for coronavirus have already received emergency use authorization from FDA to battle the pandemic.
The latest is ChromaCode, which received FDA clearance this week for its low-cost COVID-19 molecular test.
Adding next-generation gene sequencing to this testing mix aims to deliver more information about the genetic make-up of the virus from each sample — providing scientists and public health officials with a better understanding of transmission routes, comorbidities and mutation rates, among other things.
It also can serve as a foundation for vaccine development and therapies, as well as help predict future outbreaks.
“Having a next-generation sequencing diagnostic tool available will continue to expand our testing capabilities, said FDA Commissioner Dr. Stephen Hahn in a statement. “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.”
A team of about 300 workers developed Illumina’s test in just a few months. It runs on Illumina’s NovaSeq 6000 Sequencing System, which is deployed in about 920 research labs and hospitals.
According to the company, the system can process up to 3,072 samples per run, which could help support high-volume testing that some experts say is necessary to get ahead of new infections.
COVIDSeq leverages the performance of next-generation sequencing to help address the global need for diagnostic testing to fight the COVID-19 pandemic,” said Francis deSouza, chief executive of Illumina. “Beyond diagnostic testing, Illumina and a number of our customers are exploring next-generation sequencing-based workflows to enable high-volume screening to support a return to work and school.”