Wednesday, August 12, 2020

FDA’s COVID-19 Update

By on July 1, 2020

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • Today, the U.S. Food and Drug Administration (FDA) further supported its effort to evaluate diagnostic tests for COVID-19 by distributing the first round of SARS-CoV-2 reference panel materials. The panel is an independent performance validation step — for diagnostic tests of SARS-CoV-2 infection — being used for clinical, not research, purposes. The reference panel can help characterize a test’s level of detection and establish relative sensitivity among tests. The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process or whose tests have been issued an EUA. The FDA will provide the reference panel to developers at the appropriate stage in the process.
  • On June 30, FDA issued Emergency Use Authorizations to:
    • TNS Co., Ltd (Bio TNS), for its COVID-19 RT-PCR Peptide Nucleic Acid (PNA), which is authorized for use for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens. Emergency use of this molecular test is limited to laboratories certified under CLIA that meet the requirements to perform high-complexity tests.
    • The Kroger Co., for its Kroger Health COVID-19 Test Home Collection Kit, which can be used by individuals to self-collect nasal swab specimens at home, video-observed by a health care provider, when determined by a healthcare provider to be appropriate. Testing is limited to laboratories that: (1) Are certified under the Clinical Laboratory Improvement Amendments of 1988 and meet requirements to perform high-complexity tests, and (2) run the specimens on an in vitro diagnostic molecular test that is specifically indicated for use with this kit.
    • Psomagen, Inc., for its Psoma COVID-19 RT Test, which is authorized for qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory swab specimens (e.g., nasal, mid-turbinate, nasopharyngeal, oropharyngeal) and bronchoalveolar lavage specimens from individuals whose healthcare provider suspects they may have contracted COVID-19. Testing is limited to Psomagen, Inc., which is certified under the Clinical Laboratory Improvement Amendments of 1988, and meets requirements to perform high-complexity tests.
  • On June 30, the FDA and the FTC jointly issued a warning letter to the Center for Wellness and Integrative Medicine for selling unapproved and unauthorized products to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The seller offers a “COVID Supplement Protection Pack” (also referred to as the “COVID Household Value Pack”), Thymosin-Alpha, and Methylene Blue Capsules for sale in the United States. There are currently no FDA-approved products to prevent or treat COVID-19. The warning letter advised the company to take immediate corrective actions to cease the sale of the unapproved and unauthorized products. Consumers concerned about COVID-19 should consult with their health care provider.
  • Testing updates:
    • To date, the FDA has currently authorized 161 tests under EUAs; these include 135 molecular tests, 25 antibody tests, and 1 antigen test.

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