FDA Holds Town Meetings to Clarify Recent COVID-19 Diagnostics Development Guidance

Immediately in Effect for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff

April 13, 2020

The Federal Drug Administration (FDA) is holding weekly (virtual) town hall-style meetings where the in vitro diagnostics community can ask questions to clarify the FDA’s recently issued guidance for developing diagnostic tests for SAR-CoV-2. On March 16, 2020, the FDA updated its guidance on diagnostics testing for COVID-19, outlining four pathways (A–D) for diagnostic tests to be marketed in the United States.

The key takeaways from the town hall meeting on April 1, 2020, are listed below:

Home tests

  • The FDA and industry are focused on at-home tests where health care providers monitor administration of the test via telemedicine.

  • No home-use tests have been authorized at this time. Any home-use tests will need to go through pathway C and require an emergency use authorization (EUA).

Pathway A/B: CLIA Labs and State Labs

  • If a lab wishes to implement modifications to an EUA test such as changing transport media or collection swab, these changes should be validated with a bridging study. While submitting the data to the FDA is not required, the FDA notes that voluntary submissions would be of great benefit to the field.

Pathway C: Manufacturer EUA

  • Companies with CE marked tests might have enough data to qualify for an Emergency Use Authorization. CE marking is the medical device manufacturer's claim that a product meets the essential requirements of all relevant European Medical Device Directives

Pathway D: Serological tests

  • The in vitro diagnostics community needs serum from individuals who have recovered from COVID-19 to verify/validate the accuracy of the tests. The FDA offers guidance for obtaining panels on its FAQ page. Foreign suppliers reportedly have supplies available, but the FDA cautions users to check the quality of any panels obtained through this method. The FDA requests anyone experiencing difficulty importing panels to contact the FDA.

  • Serological tests using pathway D must be labeled according to the updated guidance, including disclaimers that “This test has not been reviewed by the FDA” and that “Results from antibody testing should not be used as the sole basis to diagnosis or exclude SARS-CoV-2 infection or to inform infection status.”

  • The FDA emphasized that serological tests using pathway D should not be marked as “approved” or “authorized.”

  • The FDA official indicated that a serological test will soon be authorized through the EUA process. Later the same day, the FDA announced that Cellex’s IgG/IgM COVID-19 test was authorized for emergency use.

More information:

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