Lucira Well being recordsdata for chapter because it receives EUA for residence COVID-19, flu take a look at

Lucira Well being introduced it filed for Chapter 11 chapter final week simply because the diagnostics firm obtained Emergency Use Authorization from the FDA for an at-home mixture COVID-19 and flu take a look at. 

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

Lucira stated it noticed much less demand for its residence COVID-19 take a look at in 2022, and the FDA’s regulatory course of for its mixture take a look at 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 obtained regulatory authorization,” Erik Engelson, president and CEO of Lucira Well being, stated in an announcement. “Sadly we had been unable to bridge what turned a protracted authorization cycle time inside our present capital construction and it remained unclear to us when the regulatory authorization would come by way of, regardless of working carefully with FDA. The Lucira COVID-19 & Flu Residence Check would have been particularly helpful in the course of the latest, extreme respiratory season, and we had produced stock for an anticipated autumn 2022 launch.”

The mix take a look at 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.

“Right now’s authorization of the primary OTC take a look at that may detect Influenza A and B, together with SARS-CoV-2, is a serious milestone in bringing larger shopper entry to diagnostic checks that may be carried out solely at residence,” Dr. Jeff Shuren, director of the FDA’s Middle for Units and Radiological Well being, stated in an announcement. “The FDA strongly helps innovation in take a look at improvement, and we’re desperate to proceed advancing larger entry to at-home infectious illness testing to finest assist public well being wants. We stay dedicated to working with take a look at builders to assist the shared purpose of getting extra correct and dependable checks to Individuals who want them.”

THE LARGER TREND

Based in 2013, Lucira obtained Emergency Use Authorization for its COVID-19 residence take a look at in late 2020. In October, the corporate stated it would lay off 56 workers, or a couple of quarter of its workforce. 

Many digital well being and well being tech corporations have struggled financially after increasing and elevating giant quantities of money in 2021. One other residence diagnostics firm, Cue Well being, just lately introduced plans to chop 26% of its workforce.