Lucira Health said on Tuesday it has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for over the counter (OTC) use of its at-home molecular COVID-19 & Flu test.
The molecular, single-use test fits in the palm of the hand, runs on two AA batteries, and with one shallow nasal swab provides a positive or negative result for COVID-19, flu A, or flu B in less than 30 minutes.
COVID-19 and influenza have similar symptoms but require different treatments that are most effective early in the course of an infection. As a result, it’s important to differentiate between the viruses quickly.
Last November, the FDA granted an EUA for the firm's COVID-19 & Flu test in healthcare settings. Its at-home COVID-19 test users have access to Lucira Connect, which allows them to scan the test result with a smartphone. If the results are positive, users can immediately obtain a free telehealth visit and seek treatment without leaving home.
Similarly, pending authorization of the COVID & Flu test, Lucira test users will be able to find out if they are sick with COVID-19 or influenza, talk to a doctor about treatment, and obtain an appropriate prescription.
The Lucira COVID-19 & Flu Test is a nucleic acid amplification test that uses the same platform and device design as its COVID-19 test.
Lucira said that in seeking OTC authorization it intends to make the test broadly available online and in pharmacies. The firm added that it worked closely with the FDA to complete additional testing to demonstrate that the COVID & Flu test could be used by consumers at home.
