FDA authorizes first test for patient at-home sample collection


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

  • The FDA authorized the first diagnostic test with an at-home sample collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit. Today’s reissued EUA permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. After patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing. LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks.
  • The FDA issued an EUA for the emergency use of the Sterilucent HC 80TT Hydrogen Peroxide Sterilizer for use in decontaminating compatible N95 or N95-equivalent respirators for single-user reuse by healthcare providers to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) resulting from the COVID-19 pandemic. The Sterilucent Sterilizer System is an FDA-cleared sterilization system for terminal sterilization of certain types of medical devices. This EUA authorizes expansion of the indication for decontamination of compatible N95 respirators for up to 10 decontamination cycles per respirator.
  • A new FDA Voices was issued, FDA Provides Flexibility to the Food Industry to Support Food Supply Chain and Meet Consumer Demand During COVID-19. It explains how the agency is working closely with the food industry and with the U.S. Department of Agriculture to provide flexibility regarding federal food labeling and other requirements when possible, so consumers have access to the food they want. To achieve that goal, the FDA has issued temporary guidance that provides flexibility to various segments of the food industry—restaurants, food manufacturers, producers and retail establishments—to help support the food supply chain and meet consumer demand in this time of crisis.
  • Yesterday, the FDA approved an Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Solution 0.021% and 0.042% for the relief of bronchospasm in patients 2 to 12 years of age with asthma. The agency recognizes the increased demand for albuterol products during the novel coronavirus pandemic and remains deeply committed to facilitating access to medical products to help address critical needs of the American public.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 350 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
    • To date, the FDA has issued 42 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 17 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 210 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.

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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