US Food and Drug Administration approves at-home COVID-19 molecular test

Photo of Lucira at-home COVID-19 test kit
The Lucira Health test is a molecular test, which is more sensitive and less prone to false negatives than an antigen test, according to the U.S. Food and Drug Administration website.

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On Tuesday, the U.S. Food and Drug Administration, or FDA, approved the first entirely at-home COVID-19 molecular test, which will be able to deliver results in under 30 minutes.

This latest development in the drive for reliable, accessible tests comes from Lucira Health, a company founded as a school project by four UC Berkeley graduate students who set out to create decentralized diagnostic tools.

The device is contained in an approximately $50 kit that individuals can obtain with a medical prescription. The user is instructed to swab their nostrils, and then place their swab in a sample vial. Positive tests can come back in as few as 11 minutes, according to a press release from Lucira Health.

By contrast, a leading home COVID-19 test sold at Costco costs up to $139.99 and requires users to send in their samples and wait 12-48 hours from the time a lab receives their sample for a response.

The Lucira test is a molecular test, which is more sensitive and less prone to false negatives than an antigen test, according to the FDA website. A quick molecular test is considered the “gold standard” of testing, according to Lucira Health CEO Erik Engelson.

“Lucira test results were compared with one of the most reliable FDA authorized high sensitivity SARS- CoV-2 assays available,” said company spokesperson Kevin Knight in a statement. “The comparative positive results agreed 94.1% of the time across all samples.”

For now, the test will only be available to patients served by Sutter Health in Northern California and Cleveland Clinic Florida in Miami-Ft. Lauderdale, but it is set to be available nationwide by the second quarter of 2021, according to Knight.

The test was approved by the FDA through an emergency-use authorization, added the release. Safety standards were by no means compromised, Knight said, but the process was expedited.

The goal, according to the release, is to amend the existing emergency-use authorization or create a new one so that people who believe they have been exposed to COVID-19 can get in contact with medical professionals to obtain a prescription and arrange an overnight delivery of the test kit.

Indeed, in response to skyrocketing cases, public health experts estimate that the U.S. will need to conduct as many as 100 million COVID-19 tests per month, with as many as 900 million total possible through 2021, said Knight.

The company is moving as fast as it can, and the interview with Knight was punctuated by a dozen phone calls and interview requests. When asked what the future goals for the company are, Knight laughed.

“I was going to joke and say for everybody to get a little bit of sleep,” Knight said. “The company, and everybody in it, is singularly focused on making this test available as widely as possible.”

David Villani is a general assignment reporter. Contact him at [email protected] and follow him on Twitter at @davidvillani7.