Report by Paula Antolini, April 3, 2020, 7:13AM EDT
The Food and Drug Administration (FDA) has issued its first authorization for a COVID-19 test that looks for antibodies in the blood, rather than for the virus in the nose or throat. The test is produced by the biotechnology company Cellex. In order ti run the test, health care providers must draw blood from a patient’s vein, and the test can only be done in certified labs, not a doctor’s office. The results are obtained in 15 to 20 minutes.
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The U.S. Food and Drug Administration also announced, on April 1st, the following actions taken in its ongoing response effort to the COVID-19 pandemic:
Today, the FDA announced that it is revising recommendations in several guidances regarding blood donor eligibility. These changes are based on recently completed studies and epidemiological data, leading the FDA to conclude that the polices could be modified without compromising the safety of the blood supply. The changes being announced to three guidances (HIV, malaria and CJD/vCJD) are for immediate implementation, and are expected to remain in place after the COVID-19 pandemic ends, with any appropriate changes based on comments we receive and our experience implementing the guidances. Additionally, the FDA is publishing a fourth guidance providing notice of alternatives to certain requirements regarding blood donor eligibility for the duration of the COVID-19 pandemic. The guidances are available on FDA’s web site.
Food update to date: the FDA released a public service announcement on food safety and the food supply. Consumers should rest assured that the FDA is on the job and working tirelessly to keep the American food supply among the safest in the world. The agency still reports no widespread food shortages or food safety issues.
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Today, the FDA and Federal Trade Commission (FTC) issued warning letters to three companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. With these warning letters, the FDA is exercising its authority to protect consumers from companies selling unapproved products and making false or misleading claims during the COVID-19 pandemic.
One of the companies warned, Gaia’s Whole Healing Essentials LLC., sells unapproved and misbranded colloidal silver products with misleading claims the products can build immunity for the treatment or prevention of COVID-19.
Another company warned, Homeomart Indibuy, offers homeopathic drug products for sale in the U.S. that are unapproved and misbranded with misleading claims the products are safe and/or effective for the treatment or prevention of COVID-19.
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The third company warned, Health Mastery Systems DBA Pure Plant Essentials, sells essential oils with misleading claims that the products are safe and/or effective for the treatment or prevention of COVID-19.
Diagnostics update to date:
During the COVID-19 pandemic, the FDA has worked with more than 240 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
To date, 25 emergency use authorizations have been issued for diagnostic tests. Notably, the FDA issued an emergency use authorization, on April 1, 2020, to Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test which is the first serology test to date to receive authorization to test for the presence of coronavirus antibodies. Cellex’s labeling notes that test results from this serology test should not be used as the sole basis for diagnosis and can only aid in the diagnosis of patients in conjunction with a medical review of symptoms and results of other laboratory tests. Cellex’s test is also limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate and high complexity tests.
The FDA has been notified that more than 125 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
A new FDA Voices was issued: FDA Commissioned Corps Officers on the Front Line of COVID-19 Response. Almost 400 FDA Commissioned Corps officers have been deployed to aid in response to the pandemic. Among HHS agencies, the FDA is privileged to have the second highest number of Commissioned Corps officers serving in our ranks—more than 1,100 officers in total. This allows us to truly be on call 24/7 to protect America’s food supply and essential medicines, and to ensure the safety of life-saving medical devices, vaccines and the blood supply during this pandemic. FDA’s U.S. Public Health Service (USPHS) Commissioned Corps officers are highly-trained public health professionals who work nationally and internationally in careers such as medicine, veterinary sciences, dentistry, nursing, epidemiology and biomedical research to serve underserved and vulnerable communities.
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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