Original from: 360DX

The US Food and Drug Administration said on Friday evening that it has issued an Emergency Use Authorization for Lucira Health's Lucira COVID-19 & Flu test, the first over-the-counter, at-home diagnostic test that can differentiate and detect influenza A and B, as well as SARS-CoV-2. 

The announcement comes two days after Lucira said it is filing for Chapter 11 bankruptcy protection.

According to the FDA, the test, which provides results in about 30 minutes from a self-collected nasal swab sample that is placed into a test unit, is for use by individuals who have symptoms indicative of a respiratory tract infection. 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 A samples, according to the FDA. 

The agency noted that the EUA requires Lucira to continue collecting samples to study the test's ability to detect influenza B in real-world settings as there are not enough cases of that viral infection circulating to include in a clinical study. Because of its Chapter 11 filing and as it seeks the possible sale of its business, however, Emeryville, California-based Lucira's plans to market the test are unclear. 

In announcing its Chapter 11 plans, Lucira noted that while the Lucira COVID-19 & Flu Test was under review by the FDA, it missed an opportunity to sell the test during the recent flu season.

Regardless, Jeff Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement that the authorization "is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home."

Source: After Filing for Chapter 11 Bankruptcy, Lucira Health OTC, At-Home COVID/Flu Test Gets FDA EUA