FDA hands first emergency authorization to over-the-counter test for both COVID and flu

Though the FDA has made moves in recent months to begin narrowing the steady stream of emergency use authorizations it’s handed down to COVID-19 tests throughout the pandemic, those waters haven’t yet run completely dry.

Late last week, nearly three years after issuing its first-ever EUA to a coronavirus diagnostic—a high-volume lab test from Roche that was given the greenlight barely 24 hours after its application came through—the FDA broke new ground again. This time around, the EUA marked the first given to an over-the-counter, at-home test designed to detect both COVID-19 and the flu—which also made it the first-ever test authorized to detect the flu from home.

The authorization went to Lucira Health, the FDA announced Friday. Its COVID-19 & Flu Home Test can be purchased without a prescription and includes a testing unit that looks for SARS-CoV-2 and influenza A and B in a nasal swab sample. Users aged 14 and older can collect their own samples, while children as young as 2 should be tested using samples collected by an adult.

The EUA represents “a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home,” Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in the announcement.

“The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs,” Shuren continued. “We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them.”

Lucira’s combination diagnostic returns results within 30 minutes. In clinical testing, it was able to correctly find samples negative for COVID-19 and both types of flu more than 99% of the time, per the FDA. It also accurately detected positive cases of COVID-19 and influenza A about 88% and 90% of the time, respectively.

The researchers weren’t able to assess the diagnostic’s real-world ability to identify positive cases of influenza B, however, because there aren’t enough cases of the strain currently circulating. Still, the test was able to spot the virus in “contrived specimens,” according to the FDA, and its maker is required by the EUA to continue collecting real-world samples of influenza B for further testing.

Lucira is no stranger to COVID-era emergency authorizations. In November 2020, it became the first testmaker to receive an EUA for a coronavirus diagnostic that could be used in the comfort of a user’s own home—though it still required a prescription. The molecular test runs on a single-use testing unit that had previously been in development for five years as a potential flu diagnostic.

Amid the commercial launch of that $50 test in early 2021, Lucira went public in February of that year through an IPO that brought in about $153 million. Since then, however, as demand for COVID-19 tests has dried up, the company has run into financial difficulties. It filed for Chapter 11 bankruptcy just last week, with CEO Erik Engelson citing the FDA’s slow speed in authorizing the combination test as a major factor in the company’s dwindling finances.

“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 said in a company statement Monday. “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.”

Now, according to the statement, Lucira is looking for a “strategic or financial partner” who could help the testmaker resume manufacturing and development of its additional at-home diagnostics.