- For immediate publication:
The United States Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the United States Food and Drug Administration (FDA) further supported their effort to evaluate diagnostic tests for COVID-19 by distributing the first round of materials from the SARS-CoV-2 reference panel. The panel is an independent performance validation step, for diagnostic testing of SARS-CoV-2 infection, used for clinical purposes, not research. The reference panel can help characterize the detection level of a test and establish a relative sensitivity between tests. The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (US) process or whose tests have issued a US. The FDA will provide the developer dashboard at the appropriate stage of the process.
- On June 30, the FDA issued Emergency Use Authorizations to:
- TNS Co., Ltd (Bio TNS), for its RT-PCR (PNA) peptide nucleic acid COVID-19, which is licensed for use for the qualitative detection of SARS-CoV-2 nucleic acid in respiratory samples. The emergency use of this molecular test is limited to CLIA certified laboratories that meet the requirements to perform highly complex tests.
- The Kroger Co., for its Kroger Health COVID-19 Home Test Collection Kit, which can be used by individuals to collect nasal swab samples at home, watched on video by a healthcare provider, when a healthcare provider medical attention determine that appropriate. Testing is limited to laboratories that: (1) are certified under the Clinical Laboratory Improvement Amendments of 1988 and meet the requirements for performing highly complex tests, and (2) run the samples on a diagnostic molecular test in vitro that is specifically indicated for use with this kit
- Psomagen, Inc., for its RT Psoma COVID-19 test, which is licensed for the qualitative detection of SARS-CoV-2 nucleic acid in upper respiratory swab specimens (eg, Nasal lavage, medium turbinate, nasopharyngeal, oropharyngeal) and bronchoalveolar samples 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 the requirements for conducting highly complex tests.
- On June 30, the FDA and the FTC jointly issued a warning letter to the Center for Wellness and Integrative Medicine for selling unauthorized and unauthorized products to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The vendor offers a “COVID Supplemental Protection Package” (also called a “COVID Household Value Package”), 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 action to stop selling unauthorized and unauthorized products. Consumers concerned about COVID-19 should consult their healthcare provider.
- Testing for updates:
- To date, the FDA has currently authorized 161 tests under the US; These include 135 molecular tests, 25 antibody tests, and 1 antigen test.
The FDA, an agency within the US Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and safety of medicines, vaccines, and other biological products for human use and medical devices for humans and vets. The agency is also responsible for the security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation from our country and for regulating tobacco products.
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