Morgan N. Greenleaf, Gregory L. Damhorst, Eric M. Vogel, Greg S. Martin, Wilbur A. Lam
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引用次数: 0
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 versus pandemic era diagnostics, emphasizing test-to-treat strategies versus 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.
本文探讨了Lucira Health创新的家庭分子诊断测试的开发和商业化,该测试可检测甲型流感或乙型流感和SARS-CoV-2。Lucira的产品是在对可获得的测试解决方案的迫切需求中推出的,它代表了一个重大突破,成为美国食品和药物管理局(FDA)授权的第一个非处方组合测试。从Lucira在加州大学伯克利分校(University of California-Berkeley)的微流体研究开始,到开发挑战、商业成功和失败,这本书追溯了Lucira的历程。它还对比了大流行前与大流行时期诊断的不同动机和技术挑战,强调了从检测到治疗的战略与遏制的快速结果。尽管早期取得了成功,但Lucira面临着难以逾越的监管和财务障碍,最终在FDA批准前几天破产。本案例为诊断产品开发、监管导航、产品多样化以及推动家庭和护理点诊断的战略风险管理提供了重要见解。
期刊介绍:
Lab on a Chip is the premiere journal that publishes cutting-edge research in the field of miniaturization. By their very nature, microfluidic/nanofluidic/miniaturized systems are at the intersection of disciplines, spanning fundamental research to high-end application, which is reflected by the broad readership of the journal. Lab on a Chip publishes two types of papers on original research: full-length research papers and communications. Papers should demonstrate innovations, which can come from technical advancements or applications addressing pressing needs in globally important areas. The journal also publishes Comments, Reviews, and Perspectives.