FDA approves first COVID-19 diagnostic test with genomic sequencing, updates clinician app

Jun 11, 2020 - 03:48 PM
FDA-guidance

The Food and Drug Administration yesterday authorized the first COVID-19 diagnostic test with next generation sequencing, which can generate information about the genomic sequence of the SARS-CoV-2 coronavirus. The emergency use authorization allows laboratories certified to perform high complexity tests under the Clinical Laboratory Improvement Amendments to use the test during the public health emergency. “Having a next generation sequencing diagnostic tool available will continue to expand our testing capabilities,” said FDA Commissioner Stephen Hahn, M.D. “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.”

In other news, FDA and the National Institutes of Health recently made updates to the CURE ID app, which allows health care providers to share experiences treating COVID-19 patients not enrolled in clinical trials. FDA encourages providers worldwide to use the app for communicating about new ways to use existing drugs to treat COVID-19 and other difficult infectious diseases.

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