The US Food and Drug Administration said Wednesday it has issued an emergency use authorization (EUA) to Illumina, Inc. for the first Covid-19 diagnostic test that also uses next generation genetic sequencing technology to look for changes in the virus.
Illumina, a company that focuses on genomic sequencing, has designed its COVIDSeq test for use on swabs taken from the mouth or nose, as well as samples taken from further down the respiratory tract. It can diagnose a patient with coronavirus and also gather some information about the particular sequence of the virus infecting the patient, which in turn is useful for research tracking the pandemic.
“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,” FDA Commissioner Dr. Stephen Hahn said in a statement.
Several teams of scientists have been gathering and sharing sequences of the virus, which can be used as a kind of fingerprint to see where particular versions of the virus may have originated. For instance, these sequencing studies have shown an outbreak in New York City was seeded by viruses that were also circulating in Europe, while another analysis showed small outbreaks across California were often set off by individual travelers and not by spread from within the state.
None of the genetic studies has shown that the virus is mutating in a way that makes it more or less harmful.