{"id":16388,"date":"2020-06-13T18:32:27","date_gmt":"2020-06-13T23:32:27","guid":{"rendered":"http:\/\/www.paristn.net\/articles\/?p=16388"},"modified":"2020-06-13T11:30:34","modified_gmt":"2020-06-13T16:30:34","slug":"fda-coronavirus-covid-19-update-june-13th-2020","status":"publish","type":"post","link":"https:\/\/www.paristn.net\/articles\/2020\/06\/13\/fda-coronavirus-covid-19-update-june-13th-2020\/","title":{"rendered":"FDA Coronavirus (COVID-19) Update: June 13th, 2020"},"content":{"rendered":"

\"U.S.Silver Spring, MD<\/strong> – <\/span>The U.S. Food and Drug Administration (FDA) is continuing to take action in the ongoing response to the COVID-19 Coronavirus pandemic:<\/p>\n

This week, the FDA issued an Emergency Use Authorization (EUA)<\/a> for Cue Health Inc.’s Cue COVID-19 Coronavirus Test.<\/p>\n

\"Coronavirus\"<\/a>

Coronavirus<\/p><\/div>\n

<\/p>\n

This test is authorized for use at the Point of Care, that is, in patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.<\/p>\n

Point-of-care testing means that results are delivered to patients in patient-care settings, like hospitals, urgent care centers, and emergency rooms, instead of samples being sent to a laboratory. This approach gives patients more immediate access to test results.
 <\/p>\n

The FDA issued a warning letter<\/a> to EUCYT Laboratories, LLC, for, among other things, marketing an unapproved exosome product for the treatment or prevention of COVID-19 Coronavirus. There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus.<\/p>\n

Testing updates:<\/strong><\/p>\n

To date, the FDA has authorized 135 tests under EUAs, which include 114 molecular tests, 20 antibody tests, and 1 antigen test.<\/p>\n

Additional Resources:<\/b><\/p>\n