The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- FDA and NIH have made updates to the CURE IDcrowd-sourcing app to make it easier for healthcare providers to share — via mobile device or website — their experiences treating COVID-19 patients who are unable to be enrolled in a clinical trial. CURE ID’sExternal Link Disclaimer 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.