FDA approves home combination test for influenza and COVID-19

On February 24, the FDA issued an Emergency Use Authorization for the first over-the-counter rapid test that can detect both COVID-19 and the flu. However, it is not clear when the test will be available to consumers as Lucira Health, the developer of the test, is facing financial problems. Politico.

The Lucira Health test takes about 30 minutes to get the results of a self-taken nasal swab. It detects influenza A and B, as well as SARS-CoV-2.

Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, called the approval “an important milestone in providing greater consumer access to diagnostic tests that can be performed entirely at home,” in a press release. “The FDA strongly supports innovation in test development, and we are committed to continuing to expand access to home testing for infectious diseases to best serve public health needs,” said Dr. Shuren.

Two days before the FDA released its EUA for the test, Lucira Health filed for Chapter 11 bankruptcy and said it would try to sell the business. Politico. The company said it expected the FDA to release the EUA in August 2022, ahead of flu season, “although the FDA approval process has dragged on.” Lucira said it will have more information about how the bankruptcy filing could affect rapid test deployment, production capacity and pricing at a later date.

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