NEW YORK – The US Food and Drug Administration said Friday evening that it has issued an Emergency Use Authorization for Lucira Health's Lucira COVID-19 & Flu Home Test, the first over-the-counter, at-home diagnostic test that can detect and differentiate SARS-CoV-2 and influenza A and B.
The announcement comes two days after Lucira said it is filing for Chapter 11 bankruptcy protection.
According to the FDA, the test provides results in about 30 minutes from a self-collected nasal swab sample that is placed into a test unit, and is for use by individuals who have symptoms indicative of a respiratory tract infection. The assay uses loop-mediated isothermal amplification to detect viral RNA in samples. In symptomatic individuals, Lucira COVID-19 & Flu correctly identified 99.3 percent of negative and 90.1 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.
Emeryville, California-based Lucira's plans to market the test are unclear in the wake of its Chapter 11 filing and as it seeks the possible sale of its business. In a statement on Monday, the company said that it is seeking a partner to resume the development and manufacture of diagnostic products.
Lucira also said that the length of the EUA process for the Lucira COVID-19 & Flu test made it impossible to commercialize the test, causing the firm to miss a valuable opportunity.
"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," Lucira President and CEO Erik Engelson said in the statement. "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."
He added, however, "We appreciate the diligent work of the FDA team as they refined requirements during the review cycle."
Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a separate statement that the authorization "is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home."