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FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19

FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19

Last Reviewed : 01/05/2021
FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19

Press Release: 

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Illumina, Inc. for the first COVID-19 diagnostic test utilizing next generation sequence technology. 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.

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.

 

Source: U.S. Food and Drug Administration. 

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