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FDA authorizes first at-home combo flu/Covid test

In Economy
February 26, 2023

Lucira Health\’s CEO and COO, Injlesen, stated \”This is a major milestone for Lucira\’s health and home diagnostics, and I cannot thank my colleagues and partners enough for seeing it through, and certainly for the FDA\’s consideration\”. The US flu season began on a surge in the fall and cases have since decreased, according to the CDC. It is estimated that at least 25 million flu cases have occurred this season, resulting in 280,000 hospitalizations and 18,000 deaths.

However, COVID-19 infections are still being recorded in high numbers each week; 236,000 cases and 2,400 deaths were recorded by the end of the week of February 22nd, according to the CDC.

At the start of this week, Lucira Health filed for Chapter 11 bankruptcy and announced that they would be attempting to restructure their business.

\”The Company expects to receive an EUA for OTC COVID-19 and flu tests by August 2022, pending FDA approval, which would result in fewer out-of-pocket expenses for testing in the 2022-2023 flu season, without the need for new visits,\” Lucira Health said in a press release on Monday.

Injlesen said in a statement on Friday that they would be providing answers to specific questions in the near future, such as what effects the filing will have on roll-out timing, the current manufacturing capabilities and the cost of tests.

The company\’s shares had increased by more than 85 percent in after-hours trading on Friday.

Lucira Health, a US-based diagnostics company, has achieved a major milestone in their health and home diagnostics journey. CEO and COO Injlesen expressed his gratitude to colleagues and partners for seeing it through, and to the FDA for their consideration. This comes at a time when the US is still recording high numbers of COVID-19 cases each week. The company has filed for Chapter 11 bankruptcy and is attempting to restructure their business. They expect to receive an EUA for OTC COVID-19 and flu tests by August 2022, pending FDA approval, which would result in fewer out-of-pocket expenses for testing. The company\’s shares have increased by more than 85 percent in after-hours trading.



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