FDA Finally Authorizes a COVID-19 Home Test

Arent Fox

Arent Fox

Late yesterday, November 17, 2020, the FDA issued an Emergency Use Authorization (EUA) to Lucira Health for an All-In-One Test Kit for prescription home use in individuals 14 years of age or older.

After over 8 months of the pandemic, this is the first time a COVID test has been authorized for complete self-testing at home. The test requires that a health care provider issue a prescription for the use of the test. This health care provider is then obligated to report the test results to the responsible governmental authorities.

In announcing the EUA, the FDA says that the test “can be fully administered entirely outside of a lab or healthcare setting.” This will now allow “more Americans who may have COVID-19 [to] be able to take immediate action, based on their results, to protect themselves and those around them.”

The test provides nasal swabs for self-collection of samples. The sample is then swirled in a vial that is placed in a test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that will show whether a person is positive or negative for the COVID-19 virus. Positive results indicate the presence of the virus, and individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative but who experience COVID-like symptoms are urged to follow up with their health care provider as negative results do not preclude an individual from a COVID infection.

Previously, one of the major stumbling blocks in FDA approving a completely-at-home test was FDA’s insistence that there be a mechanism to efficiently track and monitor results. Under the Lucira Health EUA, prescribing health care providers are required to report all test results they receive from individuals who use the test to their relevant public health authorities in accordance with local, state, and federal requirements. The Company has developed box labeling, quick-reference instructions, and health care provider instructions to assist with the reporting.

In addition to at-home testing, the Lucira Health test is also authorized for use in point-of-care settings (doctor’s offices, hospitals, urgent care centers, and emergency rooms) for all ages, but samples must be collected by a health care provider when the test is used to test individuals younger than 14 years of age.

Now that FDA has approved an EUA for the Lucira Health test, other manufacturers have essentially been given a blueprint for seeking EUA authorization of their own home-test kits. This will hopefully allow for other home-tests to be authorized in the near future, which could greatly streamline the testing for COVID-19 throughout the United States.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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