Lucira Health introduced it had 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 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.
The corporate mentioned it noticed much less demand for its house 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 possibility 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, mentioned in an announcement. “Sadly we have 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 Dwelling Take a look at would have been particularly helpful throughout the current, 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 ends in about half-hour.
“In the present day’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 higher shopper entry to diagnostic exams that may be carried out fully at house,” Dr. Jeff Shuren, director of the FDA’s Heart for Units and Radiological Well being, mentioned in an announcement. “The FDA strongly helps innovation in take a look at growth, and we’re desperate to proceed advancing higher 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 aim of getting extra correct and dependable exams to People who want them.”
THE LARGER TREND
Based in 2013, Lucira obtained Emergency Use Authorization for its COVID-19 house take a look at 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 corporations have struggled financially after increasing and elevating large amounts of cash in 2021. One other house diagnostics firm, Cue Well being, not too long ago announced plans to cut 26% of its workforce.