Diagnostics, BioPharma

Lucira Covid-19 test is first to get FDA nod for home use

The authorization comes as Covid-19 testing demand threatens to swamp U.S. labs. However, it will take time for the Lucira test to become available nationwide.

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The Food and Drug Administration has granted emergency use authorization to the first Covid-19 test for home use.

The nose-swab test – available only by prescription – was developed by Lucira Health, founded in 2013 and based in Emeryville, California.

Demand is likely to be high, as the Covid-19 virus sweeps across the United States and people crowd into testing sites. Noting an increase in testing volume, the American Clinical Laboratory Association last week warned in a statement that labs were reaching capacity, potentially slowing down their ability to deliver results.

The Lucira test, expected to cost around $50, promises results in up to 30 minutes. But it will not be available on a nationwide basis until early spring of 2021, according to a press release from the company. The test will be rolled out first to patients of Sutter Health in Northern California and Cleveland Clinic Florida in the Miami area.

By the second quarter of 2021, Lucira hopes to amend its emergency use authorization so that people can consult online with doctors who can prescribe the test and ship it directly to patient homes.

“Being able to quickly determine if a person is infected or not has been a global problem,” Dr. John Chou, a physician with the Palo Alto Foundation Medical Group, a Sutter Health affiliate, said in a statement. He also was a principal investigator on a Lucira study submitted to the FDA. “We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently. Early, accurate detection is vital to delivering appropriate care and controlling the pandemic.”

The Lucira Covid-19 All-In-One Test Kit involves three steps: swab, stir and detect. Patients put a sample vial in a battery-powered test unit, swab their nostrils, stir the swab in the vial, then press the vial into the test unit. A red or green light will indicate a negative or positive test within 30 minutes.

In clinical trials, 100% of patients were able to perform the test successfully in about two minutes, Lucira said.

The test is molecular, meaning it extracts genetic material from the virus and amplifies it, according to Lucira. The other class of tests are antigen tests, which detect viral proteins. They are usually quicker but less accurate.

“Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests and considered the ‘gold standard’ for determining if someone is infected,” Lucira CEO Erik Engelson said in a statement.

False positives are uncommon, according to data presented by Lucira. For positive results, the Lucira test agreed 94.1% of the time with one of the most sensitive FDA-approved tests, the company said. The two tests agreed 100% of the time when excluding samples with low levels of virus. For negative results, the two tests agreed 98% of the time.

Lucira began developing the test around five years ago for the flu, with the idea that patients could buy it at drug stores. The company pivoted to Covid-19 earlier this year.

Other tests also promise quick results. Access Bio, based in Somerset, New Jersey, won emergency use authorization in October for an antigen test that gives results in 10 minutes. It is designed to be administered in point-of-care settings by non-laboratory medical professionals. Clinical validations show the test has a sensitivity rate of 88.4% and a specificity rate of 100%.