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Friday, January 15th, 2021

FDA grants emergency use authorization to Illumina for COVID-19 test

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The U.S. Food and Drug Administration granted an emergency use authorization to Illumina for the first COVID-19 diagnostic test utilizing next generation sequence technology.

The Illumina COVIDSeq Test is for the qualitative detection of SARS-CoV-2 RNA from respiratory specimens collected from individuals suspected of COVID-19. It uses next generation sequencing, which means that the test can generate information about the genomic sequence of the virus present in a sample.

“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. 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 Stephen Hahn said.

Next generation sequencing can help determine, among other things, the genetic sequence of a virus. This can help scientists understand how viruses mutate.

The FDA is an agency within the U.S. Department of Health and Human Services. It protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, and tobacco products.