Work

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

Year: 2025

Type: article

Abstract: 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.

Source: Lab on a Chip

DOI: 10.1039/d5lc00305a

Authors: Morgan N. Greenleaf, Gregory L. Damhorst, Eric M. Vogel, Greg S. Martin, Wilbur A. Lam

Institutions: Georgia Clinical and Translational Science Alliance, Emory University, Georgia Institute of Technology, The Wallace H. Coulter Department of Biomedical Engineering, Children's Healthcare of Atlanta

Language: English

Topic: SARS-CoV-2 detection and testing

Subfield: Infectious Diseases

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Funders: National Institute of Biomedical Imaging and Bioengineering, National Center for Advancing Translational Sciences