From startup to shutdown: the dramatic rise and fall of the first at-home combo test for flu and COVID-19.

Abstract

This article explores the development and commercialization of Lucira Health's innovative at-home molecular diagnostic test, which detects influenza A or B and SARS-CoV-2. Launched amidst the urgent demand for accessible testing solutions, Lucira's product represented a significant breakthrough, becoming the first over-the-counter combination test authorized by the US Food and Drug Administration (FDA). The narrative tracks Lucira's journey from its origins in microfluidics at the University of California-Berkeley, through development challenges, business success and failure. It also contrasts the distinct motivations and technical challenges of pre-pandemic <i>versus</i> pandemic era diagnostics, emphasizing test-to-treat strategies <i>versus</i> rapid results for containment. Despite early successes, Lucira faced insurmountable regulatory and financial hurdles, culminating in bankruptcy just days before FDA authorization. The case offers critical insights into diagnostics product development, regulatory navigation, product diversification, and strategic risk management in push towards home and point of care diagnostics.