Lucira applies for authorization of at-home COVID-19 & Influenza tests

Lucira Health, a medical company headquartered in California, U.S., has announced the submission of request for emergency use authorization (EUA) of its Covid-19 and Flu test to the U.S. Food and Drug Administration (FDA).

The application filed, requests for prescribed at-home use of the PCR-quality test for potential Covid-19 and Influenza patients.

The company, focused on development and commercialization of novel tests for infectious disease detection, is seeking FDA approval prior to fall and winter this year – a period when both SARS-CoV-2 and Influenza are expected to spread. 

Erik Engelson, President and CEO of Lucira Health emphasized on the latest filing to be an important milestone for the company in launching the first at-home Covid-19 & Flu test.

According to Engelson, Lucira was established with the aim of enhancing accessibility to lab-quality diagnostics for people who are more prone to fall sick. It is also speculated to provide faster, more affordable, and easier pathway to treatment.

Lucira believes that introducing an at-home test for Covid-19 and Influenza at a time when there is plenty availability of antivirals and loosening pandemic restrictions, causing resurgence of other respiratory viruses, will improve access to critical therapeutics when they are most needed.

For the record, Lucira testing tool is a Nucleic Acid Amplification Test (NAAT), which offers sensitivity and specificity almost equivalent to lab-based PCR assays miniaturized within a palm sized device capable of generating results within 30 minutes without needing a separate device.

The Covid-19 & Flu test of Lucira showcases the same miniaturized palm-sized device design and uses the same platform to independently test for Flu A, Flu B, and Covid-19 infection with a single nasal swab.

Sensitivity and specificity of Lucira Covid-19 & Flu test – which recently nabbed CE Mark and is undergoing submissions across several different regulatory authorities - were demonstrated via clinical trials which showcased positive results comparing to the leading lab-based PCR assays. 

In 2020, the standalone Covid-19 test of Lucira became the first at-home Covid-19 test to receive emergency authorization from the FDA.

Source Credit: https://www.globenewswire.com/news-release/2022/05/12/2441746/0/en/Lucira-Files-for-Authorization-of-First-of-its-Kind-COVID-19-Flu-At-Home-Molecular-Test.html