FDA authorizes first next generation sequence test for COVID-19 diagnosis

WASHINGTON - The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to American company Illumina, Inc., for the first COVID-19 diagnostic test utilizing next generation sequence technology, according to a FDA release on Wednesday.

The FDA authorized the Illumina COVIDSeq Test for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.

Using next generation sequencing means that the test can generate information about the genomic sequence of the virus present in a sample, which can be also used for research purposes, according to the FDA.

"Throughout the COVID-19 pandemic, we have seen the ingenuity that results from the FDA working in partnership with the private sector. Having a next generation sequencing diagnostic tool available will continue to expand our testing capabilities," said FDA Commissioner Stephen Hahn.

"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," he said.

Next generation sequencing is a type of diagnostic technology that can determine, among other things, the genetic sequence of a virus. Comparing sequencing results over time can help scientists understand if and how viruses mutate, according to the FDA.