Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., July 1, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response 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 Federal Trade Commission 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.

Additional Resources:

    --  FAQs on Testing for SARS-CoV-2
    --  Policy for Coronavirus Disease-2019 Tests During the Public Health
        Emergency (Revised)
    --  Coronavirus Disease 2019 (COVID-19)

Media Contact: Lee.Herring@fda.hhs.gov, 240-402-6386
Consumer Inquiries: 888-INFO-FDA

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.

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SOURCE U.S. Food and Drug Administration