Last Friday, the Food and Drug Administration (FDA) granted emergency use authorization to the Lucira COVID-19 and Flu Test, making it the first at-home flu test approved for US consumers. The decision came just days after Lucira filed for Chapter 11 bankruptcy, blaming a protracted approval process for a test it had anticipated would be approved last August. As Lucira was unable to find a buyer prior to filing for bankruptcy, it remains unclear if the test will ever reach store shelves.
The Gist: While most Americans first experienced at-home viral testing with COVID, Europeans have used the same underlying technology to diagnose themselves with the flu at home for years. Lucira’s test was only approved because its capacity to detect COVID qualified it for emergency approval, and even then, approval took so long that the company began to falter. Many have questioned the FDA’s slow-walking of at-home diagnostics, especially now that Americans have demonstrated both the willingness and ability to swab their own noses.
With the locus of care shifting towards the home, and in an environment of cost-conscious consumers, the push for more at-home diagnostics will continue to grow.