Authorization

Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., June 10, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

FDA and NIH have made updates to the CURE ID crowd-sourcing app to make it easier for healthcare providers to share a?? via mobile device or website a?? their experiences treating COVID-19 patients who are unable to be enrolled in a clinical trial. CURE ID's web-based repository lets providers share experiences with novel uses of existing drugs in treating difficult-to-treat infectious diseases. Healthcare providers worldwide are encouraged to share their COVID-19 treatment experiences via CURE ID.




The FDA 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 a COVID-19 infection by their healthcare provider. 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.




Testing updates:



To date, the FDA has authorized 131 tests under EUAs, which include 111 molecular tests, 19 antibody tests, and 1 antigen test.

Additional Resources:

FAQs on Testing for SARS-CoV-2



Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)



Coronavirus Disease 2019 (COVID-19)

Media Contact:A Lee.Herring@fda.hhs.gov, 240-402-6386
Consumer Inquiries: 888-INFO-FDAThe FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Coronavirus (COVID-19) Update: Daily Roundup
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