The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits. These newly authorized testing options are expected to help address the critical public health need for additional COVID-19 test capacity. FDA’s authorization of these new EUAs also makes good on promises the Agency made to prioritize its review of rapid and at-home test solutions.
These new EUAs are significant for test developers looking to enter the COVID-19 test space and eyeing a quick FDA authorization process because they provide useful insights regarding the Agency’s review priorities and expectations with respect to data and test performance.
Recent Significant EUAs
- First OTC COVID-19 At-Home Test: FDA announced on December 15 its authorization for the first OTC (non-prescription) COVID-19 test intended to be performed at home. Specifically, this new EUA covers the Ellume test, a single-use, OTC antigen test indicated for symptomatic and asymptomatic individuals that detects protein fragments of the SARS-CoV-2 virus from a self-collected nasal swab. As described further below, FDA had authorized earlier in December an OTC home sample collection option, but the Ellume test represents the first test to be performed fully at home without requiring a prescription order. The Ellume test includes a specimen analyzer that connects to a smartphone app to help users perform the test and to read and understand the results. The Ellume test is authorized for use with specimens self-collected by an individual aged 16 years or older, or are collected by an adult from an individual 2 years of age and older. The Ellume test will reportedly cost around $30 and will be available for purchase in pharmacies and online. In the company’s own press release, Ellume stated that it plans to manufacture and deliver 20 million of its at-home tests to the United States in the first half of 2021. It is important to note that this first EUA-authorized OTC home test provides only an antigen testing option—FDA has not yet authorized any COVID-19 OTC tests for molecular or serological (antibody) testing.
- New Prescription COVID-19 At-Home Tests: FDA also announced in December that it had reissued the EUA for the Abbott BinaxNow Ag Card antigen test to permit the test to be performed at home under telehealth supervision. FDA initially authorized the BinaxNow Ag Card antigen test for use only in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) or at Point-of-Care (POC) settings operating under a CLIA Certificate of Waiver (CW). This is the second EUA authorized for a prescription use COVID-19 test intended to be performed at home. The BinaxNow Ag Card test is authorized for use with specimens self-collected by an individual aged 15 years or older, or are collected by an adult from an individual 4 years of age and older. FDA authorized the first COVID-19 test for use at home in November—the Lucira COVID-19 All-In-One Test Kit. Both the Abbott BinaxNow Ag Card test and the Lucira COVID-19 All-In-One Test Kit are restricted to prescription use only; however, the Lucira test is a molecular test whereas the Abbott test is an antigen test. FDA has yet to authorize any serological (antibody) tests for home use.
- First OTC Home Sample Collection Kit for COVID-19 Testing: FDA announced on December 9 its authorization of the first direct-to-consumer (nonprescription) home sample collection kit for COVID-19 testing. Specifically, this EUA covered LabCorp’s Pixel COVID-19 Test At-Home Collection Kit. The kit is authorized for use with specimens self-collected by an individual aged 18 years or older. Although FDA had approved several EUAs for at-home sample collection over the past few months (the first EUA for at-home sample collection was authorized in May), these sample collection kits were all limited to prescription use only. The new LabCorp Pixel OTC sample collection kit allows adults aged 18 years and older to purchase the sample collection kit without a prescription, collect their own specimens, and send the specimens to LabCorp’s CLIA-certified laboratories for processing using LabCorp’s COVID-19 RT-PCR (molecular) test. To date, all FDA-authorized at-home sample collection kits are intended for use with molecular tests. There are not currently any authorized at-home sample collection options for antigen or serology (antibody) tests.
- First COVID-19 and Flu Combination Test for Use with At-Home Sample Collection: On December 4, FDA announced its authorization for the first combination COVID-19 and flu test for use with at-home sample collection—the Quest Diagnostics RC COVID-19 +Flu RT-PCR Test with self-collection kit. The Quest self-collection kit, however, was authorized as prescription use only. The kit is authorized for use with specimens self-collected by an individual aged 18 years or older.
Considerations for Test Developers
Manufacturers in the process of developing COVID-19 tests should view the recent spate of FDA authorizations as a strong signal that the Agency is prioritizing the authorization of tests for use in non-laboratory settings (e.g., homes) when compared to laboratory settings (e.g., molecular-based tests authorized for use in CLIA-certified laboratories). The lynchpin as to whether FDA will authorize the test for OTC use continues to be whether the manufacturer has validated the device for use with both symptomatic and asymptomatic patients; tests that only have symptomatic validation data will be limited for use under a prescription order regardless of test setting.
The recent authorizations also show FDA’s flexibility with respect to authorizing tests that have not fully completed development testing. Specifically, FDA appears to be more willing to permit as “Conditions of Authorization” design verification and/or validation testing that would routinely be done prior to FDA authorization, including:
- mechanisms for reporting test results to public health authorities;
- software validation;
- flex studies which evaluate use errors associated with the test; and
- electromechanical testing (EMC).
To date, FDA’s authorizations with respect to testing in home-use settings concern antigen and molecular tests; FDA has not authorized a serology test (including collection devices) for home use. Serology tests may present unique challenges that make it difficult for a home-use setting. For example, serology tests generally require a blood specimen. Developing safe blood collection devices suitable for home use (even under the telehealth supervision of a professional) may be challenging. On November 24, 2020, FDA published an EUA template document for serology at-home specimen collection kits subject to a prescription order (the template did not address the possibility of testing being performed in a non-laboratory setting). The EUA template includes FDA’s data expectations for such devices, which include the performance of a human usability study, specimen stability study, and clinical performance evaluation.
How We Can Help
Throughout the COVID-19 pandemic, Morgan Lewis is assisting test developers with regulatory strategy for seeking FDA authorization through the least burdensome approach. Morgan Lewis assists test developers in preparing EUA submissions and interacting with the agency to help ensure timely review and authorization of submissions. Morgan Lewis also provides counseling to employers on employee COVID-19 test programs.
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Contacts
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:
Washington, DC
Dennis Gucciardo
Michele Buenafe