FDA Clears First At-Home, Over-The-Counter COVID-19 Test

WASHINGTON — The first COVID-19 test that can be performed entirely from home was cleared by U.S. regulators on Tuesday, and it can be acquired without a prescription.

While availability initially will be limited, the new test and others in development could make virus screenings as accessible as over-the-counter pregnancy tests in the U.S. for the first time. The advance follows months of criticism that the Food and Drug Administration has been too slow to give its approval to this type of virus screening.

Manufactured by East Brisbane, Australia-based Ellume, the self-administered, single-use nasal-swab test is small enough to fit in the palm of a person’s hand. The test detects proteins on the virus’s surface in 15 minutes and delivers results to a smartphone app.

The test will cost about $30. Ellume plans to manufacture 100,000 tests a day starting in January, Chief Executive Officer Sean Parsons said in an interview prior to the FDA authorization. The company, which received about $30 million from a National Institutes of Health program to scale up manufacturing, could be making a million tests a day by mid-2021, Parsons said.

“Self-testing, from the things we’ve learned along the way, is a good deal harder than it looks,” Parsons said. “This product was designed to be put in the hands of consumers directly, and we believe we have shown comprehensively that users can use it correctly and can interpret the results.”

Testing has been a key line of defense against the virus. Even so, throughout the pandemic test-seekers have persistently confronted a frustrating, time-consuming and costly process, with obstacles such as long lines and slow turnaround times.

Remedying that has been a goal of advocates like Michael Mina, a Harvard epidemiologist, who has called for making inexpensive tests widely available for convenient, frequent screening.

“Somebody in government needs to realize that enough is enough,” Mina said in a briefing last month. He called on officials to “act in the best interest of Americans.”

Currently, the vast majority of U.S. COVID-19 tests are performed in a medical setting and require a prescription, including an at-home test from Lucira Health Inc. cleared by the FDA last month. A test from Laboratory Corp of America Holdings that doesn’t require medical authorization but needs to be sent t a lab to process was cleared by the agency last week

©2020 Bloomberg L.P.

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