Lucira Gets FDA Authorization for First OTC At-Home Test for COVID-19 and Flu

Lucira Gets FDA Authorization for First OTC At-Home Test for COVID-19 and Flu

Lucira was the first testmaker to have received FDA authorization for an at-home COVID-19 diagnostic back in November 2020.

The US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Lucira Health’s combo COVID-19 and flu test, making it the first approved at-home test that can simultaneously test for both respiratory infections.

The Lucira COVID-19 & Flu Home Test is available over the counter (OTC) and can differentiate and detect influenza A, B (viruses that cause influenza, commonly known as the flu) and the COVID-19-causing SARS-CoV-2 viruses.

Lucira’s dual diagnostic is a single-use test for individuals with signs and symptoms of a respiratory tract infection, including COVID-19.

The test is a rapid molecular PCR test that can produce results in about 30 minutes.

The test can be purchased by individuals 14 years of age and older without a prescription and performed at-home using self-collected nasal swab samples. Samples can be collected by individuals ages 14 years or older or by an adult for individuals 2 years of age or older.

Experts are predicting that COVID-19 may require annual boosters, much like annual flu shots, making the availability of diagnostic tests for respiratory viruses like COVID, influenza and RSV important, especially during flu season. Differentiating between the viruses can be important in seeking timely and appropriate treatment.

Related: CDC Expresses Concern Over New COVID-19 Variant BF.7

Test results can be uploaded as a digital copy on the Lucira Connect website and shared with healthcare providers. People can also connect to telehealth via the website to discuss care and treatment options, according to Lucira.

The Lucira COVID-19 & Flu Home Test was validated in clinical studies, results of which showed that among symptomatic individuals, the test correctly identified 99.3 percent of negative and 90 percent of positive Influenza A samples, 100 percent of negative and 88.3 percent of positive COVID-19 samples and 99.9 percent of negative Influenza B samples.

According to the FDA press release announcing the authorization of the test, the FDA said the EUA requires Lucira to continue collecting samples to evaluate the test’s ability to detect Influenza B in real-world settings. This is because there are currently not enough Influenza B cases circulating to include in a clinical study. Nevertheless, the test’s ability to identify the virus was confirmed in contrived specimens.

Lucira says results of a positive COVID-19 result take about 11 minutes and 30 minutes for a negative result.

Lucira’s latest COVID-19 diagnostic offering is not its first. In November 2020, Lucira became the first testmaker to receive an EUA for a COVID-19 test that could be used at home; however, that test required a prescription.

The company had been developing the molecular test technology for flu diagnostic tests for five years prior to the COVID-19 pandemic.

In a company statement announcing the EUA for its latest diagnostic, Lucira said it believes a single test for both COVID-19 and flu can be a powerful tool given how similar the two viruses appear.

“COVID-19 and flu look the same, feel the same, spread the same and, unfortunately, can still kill the same,” said Dr. Davey Smith, Head of the Division of Infectious Disease and Global Public Health at the University of California, San Diego in the statement. “Having an at-home molecular test now available should really help people know how to keep their families safe and seek appropriate treatment when they’re ill.”

Prior to the latest EUA for its combination test, Lucira had been facing significant financial woes due to plummeting demand for COVID-19 tests. The company filed for Chapter 11 bankruptcy just days before its combo COVID-flu test was authorized.

Addressing the bankruptcy in the statement, Lucira CEO Erik Engelson said the company regrets having had no option but to file for bankruptcy, and cited the FDA’s lack of speed in authorizing the combination test as a major factor in the company’s financial setback.

“Unfortunately, we were unable to bridge what became a protracted authorization cycle time within our current capital structure, and it remained unclear to us when the regulatory authorization would come through, despite working closely with FDA,” he explained.

“The Lucira COVID-19 & Flu Home Test would have been especially useful during the recent, severe respiratory season, and we had produced inventory for an anticipated autumn 2022 launch.”

Lucira said it is now looking for a “strategic or financial partner” who could help resume manufacturing and development of more at-home test products.

Lucira’s combination test has been available in Canada since August 2022 and costs about $98 CAD per test. It hasn’t been announced when the test will be available in the US.