- For Immediate Release:
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.
The 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.
- Lee Herring