FDA authorizes first at-home combo flu/Covid test
“It is a main milestone for Lucira Well being and at-home diagnostics, and I can’t thank our workers and companions sufficient for seeing this by, and naturally, for the FDA’s recognition,” stated Erik Engelson, president and CEO of Lucira.
Illness burden: The U.S. flu season peaked early final fall and instances at the moment are low, according to the CDC. The company estimates no less than 25 million flu diseases have occurred this season, leading to 280,000 hospitalizations and 18,000 deaths.
However there are nonetheless a substantial variety of Covid-19 infections being recorded every week: greater than 236,000 instances and a pair of,400 deaths have been recorded as of the week ended Feb. 22, according to the CDC.
Chapter submitting: Earlier this week, Lucira Well being filed for Chapter 11 chapter and introduced it might attempt to promote its enterprise.
“The Firm anticipated an EUA for an OTC indication on the COVID-19 and Flu test in August 2022, although the FDA’s approval course of grew to become protracted, leading to excessive expenditures with out new income from the mixed test equipment in the course of the 2022-2023 flu season,” Lucira Well being stated in a press launch on Wednesday.
What’s subsequent: Lucira Well being stated on Friday that it might reply at a later date particular questions in regards to the affect the chapter submitting would have on the rollout timing of the test, what present manufacturing capability is or what the worth for the test can be.
“We filed a collection of first day motions with the Courtroom and upon approvals, absolutely intend to maneuver ahead in regular course operations, whereas concurrently pursuing a sale course of,” Engelson stated in an announcement Friday.
The corporate’s inventory worth jumped greater than 85 % in after-hours buying and selling.
