On December 15, 2020, the U.S. Food and Drug Administration (FDA) finally issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test that detects fragments of proteins on the SARS-CoV-2 virus from a nasal swab sample collected from any individual two years of age or older.1 As voiced by FDA Commissioner Stephen M. Hahn, M.D., this is “a major milestone in diagnostic testing for COVID-19.” By authorizing this test as an OTC product, the FDA makes the Ellume COVID-19 Home Test available at places like retail drug stores, substantially expanding American consumers’ access to COVID-19 testing and reducing the burden on laboratories. For the first time, without the need for a prescription, consumers can get tested for COVID-19 from the safety of their own homes and find out their results in as little as 20 minutes. According to the FDA, Ellume expects to produce more than three million tests in January 2021.
This announcement follows the FDA’s authorization of the first non-prescription direct-to-consumer (DTC) COVID-19 clinical laboratory test system on December 9, 2020—Pixel by LabCorp COVID-19 Test Home Collection Kit, which makes the nasal sample collection kit more widely available to consumers online or in retail stores without a prescription, allowing consumers to collect their samples from the safety of their own homes and send them to LabCorp for processing.2 LabCorp’s Pixel test is a molecular test that uses real-time reverse transcription polymerase chain reaction (rRT-PCR) technology to detect the SARS-CoV-2 virus.
Interestingly, this LabCorp EUA for a clinical laboratory test system comes after the FDA’s October 2020 announcement in the agency’s FAQ page that it will no longer review COVID-19 EUA submissions for laboratory-developed tests (LDTs).3 It is possible that the FDA’s regulatory position on sample collection kits is carved out of its current policy with respect to EUA submissions for LDTs, or the LabCorp Pixel EUA may be an unique case since the FDA had re-issued LabCorp’s previous EUA to permit at-home sample collection in April 21, 2020, which occurred before the FDA announced that it would no longer review EUA submissions for LDTs.4 Nevertheless, clinical laboratories that are interested in developing COVID-19 LDTs with a direct-to-consumer or at-home sample collection kit should be aware that the FDA’s current policy on LDT EUA submissions may not apply to such sample collection kits.
As noted in the FDA’s FAQ page, the FDA is prioritizing review of EUA requests for tests that would increase testing accessibility (e.g., point-of-care tests, home collection tests, and at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies and high-throughput widely distributed tests).5 These milestones in at-home COVID-19 testing comes at a critical time when COVID-19 cases are at an all-time high in the United States.
Eva Yin contributed to the preparation of this Wilson Sonsini Alert.
[1] FDA, News Release, December 15, 2020.
[2] FDA, News Release, December 9, 2020.
[3] Centers for Disease Control and Prevention (CDC), Laboratory Alert, October 9, 2020.
[4] FDA, News Release, April 21, 2020.
[5] FDA, COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2, Q: What are FDA’s priorities with respect to review of EUA requests for COVID-19 tests? (Updated 12/2/20).
