Lucira Well being recordsdata for chapter because it receives EUA for dwelling COVID-19, flu check

Lucira Health introduced it filed for Chapter 11 chapter final week simply because the diagnostics firm acquired Emergency Use Authorization from the FDA for an at-home mixture COVID-19 and flu check. 

Within the firm’s bankruptcy filing, it lists about $146 million in property and liabilities of round $85 million. Lucira plans to make use of roughly $4.5 million money available to fund operations because it seeks to promote itself. 

Lucira mentioned it noticed much less demand for its dwelling COVID-19 check in 2022, and the FDA’s regulatory course of for its mixture check took longer than anticipated. 

“We remorse that we had no choice however to file for Chapter 11 chapter and that this occurred days earlier than we acquired regulatory authorization,” Erik Engelson, president and CEO of Lucira Well being, mentioned in a press release. “Sadly we had been unable to bridge what grew to become a protracted authorization cycle time inside our present capital construction and it remained unclear to us when the regulatory authorization would come via, regardless of working intently with FDA. The Lucira COVID-19 & Flu Dwelling Check would have been particularly helpful through the current, extreme respiratory season, and we had produced stock for an anticipated autumn 2022 launch.”

The mix check marks the first authorization for an over-the-counter and at-home diagnostic that may detect and differentiate between the viruses that trigger flu and COVID-19. It makes use of a nasal swab to supply leads to about half-hour.

“Immediately’s authorization of the primary OTC check that may detect Influenza A and B, together with SARS-CoV-2, is a significant milestone in bringing better shopper entry to diagnostic checks that may be carried out fully at dwelling,” Dr. Jeff Shuren, director of the FDA’s Heart for Gadgets and Radiological Well being, mentioned in a press release. “The FDA strongly helps innovation in check growth, and we’re desirous to proceed advancing better entry to at-home infectious illness testing to finest assist public well being wants. We stay dedicated to working with check builders to assist the shared purpose of getting extra correct and dependable checks to People who want them.”

THE LARGER TREND

Based in 2013, Lucira acquired Emergency Use Authorization for its COVID-19 dwelling check in late 2020. In October, the corporate mentioned it would lay off 56 employees, or a couple of quarter of its workforce. 

Many digital well being and well being tech firms have struggled financially after increasing and elevating large amounts of cash in 2021. One other dwelling diagnostics firm, Cue Well being, not too long ago announced plans to cut 26% of its workforce.