COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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New EUA Makes COVID-19 Testing Available for Patients Without Clinical Laboratories Playing a Role

Models forming toward at-home testing for COVID-19.

First EUA for at-home and over-the-counter COVID-19 testing removes the need for clinical laboratories to perform COVID-19 diagnostic testing

Less than a week after the US Food and Drug Administration (FDA) issued the first-ever emergency use authorization (EUA) for an over-the-counter COVID-19 test, another test has advanced the accessibility of COVID-19 testing even further. The FDA issued an EUA Dec. 15, 2020, to Ellume for the Ellume COVID-19 Home Test, the first-ever COVID-19 test that can be purchased without a prescription and can be performed completely at home.

While one other at-home COVID-19 test, the Lucira COVID-19 All-In-One Test Kit, has received EUA authorization, this test is not expected to be available nationally for several months, and it requires a prescription by a healthcare professional. (See At-Home COVID-19 Testing Finally Arrives: Laboratory Expert Weighs in on the Implications for Clinical Laboratories.) With Lucira’s test, there are also age restrictions and cost considerations that raise questions about how quickly and effectively the test will be brought to market.

Comparing At-Home COVID-19 Tests

The Ellume test appears to have several advantages over the Lucira test. This new test can notably be purchased without a prescription, making it the second COVID-19 test to achieve this unique regulatory milestone, and the first to combine it with at-home testing capabilities. This test can also be used for children as young as 2 years old and, while the cost of the test is not yet public, it does appear that the cost will be substantially less than the Lucira at-home test.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” Ellume Founder and CEO, Sean Parsons said in a recent statement. “Ellume’s COVID-19 Home Test delivers this important first line of defense—it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage.”

According to a statement released by Ellume announcing the new EUA, “Ellume will be shipping over 100,000 tests per day from next month.” The statement also addresses the company’s long-term manufacturing plans. “Ellume plans to manufacture and deliver 20 million Ellume COVID-19 Home Tests to the U.S. within the first half of 2021.”

FDA’s Hahn on Acceleration of Complete At-Home COVID-19 Testing

This new EUA marks a significant step in moving COVID-19 testing out of clinical laboratories and directly into the hands of patients. “Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” FDA Commissioner Stephen M. Hahn, MD, stated as part of the FDA announcement. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”

This new milestone in COVID-19 testing technology may serve as both a benefit and a negative for clinical laboratories. With SARS-CoV-2 testing supply shortages and the strain affecting other lab tests, the reprieve that comes with the availability of at-home, over-the-counter testing will eventually help to reduce the heavy workload that clinical laboratories face. This may, however, also serve to eventually reduce COVID-19 test volumes and, thus, the revenue that COVID-19 testing brings—a potential downside for clinical labs.

Caleb Williams

—By Caleb Williams, Editor, COVID-19 STAT

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