First COVID-19 Test of Its Kind Approved Leave a comment


(RxWiki News) The first COVID-19 diagnostic test that uses next-generation sequence technology has gotten the green light from the US Food and Drug Administration (FDA).

The FDA recently announced that it has issued an emergency use authorization (EUA) to the company Illumina, Inc., for its COVIDSeq Test.

This test can detect SARS-CoV-2 RNA from respiratory collections of those who are suspected to have COVID-19. Collections can be taken from the nose and throat — specifically through nasopharyngeal, oropharyngeal and mid-turbinate nasal swabs.

The COVIDSeq Test uses next-generation sequence technology to show information on the genetic sequence of the virus. This is particularly important because scientists can compare results over time and see if the virus is mutating, the FDA noted.

“Throughout the COVID-19 pandemic, we have seen the ingenuity that results from the FDA working in partnership with the private sector,” said FDA Commissioner Dr. Stephen Hahn in a press release. “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.”

This test is by prescription only. Furthermore, it is not authorized for use through regular FDA approval. This test is authorized only for the detection of SARS-CoV-2 and not for any other viruses.

If you are concerned and believe you have COVID-19, call ahead to your doctor or a health care facility.

You will be asked about your symptoms and exposure. Your doctor or health care facility will decide whether you need to be observed in person. They may consult with your state authorities regarding where and how to perform the testing. You will be given instructions on how to get tested in a way that limits exposure to other people. Calling ahead is important to protect others.

Contact your state health department if you have any questions about testing.



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