Public investments in the development of GeneXpert molecular diagnostic technology.

Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE

Original Publication: San Francisco, CA : Public Library of Science

Investments*; Molecular Diagnostic Techniques/*economics; COVID-19/diagnosis ; COVID-19/virology ; Databases, Factual ; HIV Infections/diagnosis ; History, 20th Century ; History, 21st Century ; Humans ; Molecular Diagnostic Techniques/history ; SARS-CoV-2/isolation & purification ; Tuberculosis/diagnosis ; United States

Background: The GeneXpert diagnostic platform from the US based company Cepheid is an automated molecular diagnostic device that performs sample preparation and pathogen detection within a single cartridge-based assay. GeneXpert devices can enable diagnosis at the district level without the need for fully equipped clinical laboratories, are simple to use, and offer rapid results. Due to these characteristics, the platform is now widely used in low- and middle-income countries for diagnosis of diseases such as TB and HIV. Assays for SARS-CoV-2 are also being rolled out. We aimed to quantify public sector investments in the development of the GeneXpert platform and Cepheid's suite of cartridge-based assays.
Methods: Public funding data were collected from the proprietor company's financial filings, grant databases, review of historical literature concerning key laboratories and researchers, and contacting key public sector entities involved in the technology's development. The value of research and development (R&D) tax credits was estimated based on financial filings.
Results: Total public investments in the development of the GeneXpert technology were estimated to be $252 million, including >$11 million in funding for work in public laboratories leading to the first commercial product, $56 million in grants from the National Institutes of Health, $73 million from other U.S. government departments, $67 million in R&D tax credits, $38 million in funding from non-profit and philanthropic organizations, and $9.6 million in small business 'springboard' grants.
Conclusion: The public sector has invested over $250 million in the development of both the underlying technologies and the GeneXpert diagnostic platform and assays, and has made additional investments in rolling out the technology in countries with high burdens of TB. The key role played by the public sector in R&D and roll-out stands in contrast to the lack of public sector ability to secure affordable pricing and maintenance agreements.
Competing Interests: DG received a research grant for this analysis from Treatment Action Group as an independent researcher. The funder (Treatment Action Group) provided support in the form of salaries for authors DB, LM, SM, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section. This does not alter our adherence to PLOS ONE policies on sharing data and materials. SD is an employee of Médecins Sans Frontières. Treatment Action Group and Médecins Sans Frontières have long advocated for lowering the price of GeneXpert tests in low- and middle income countries. The authors declare no other competing interests.

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Date Created: 20210831 Date Completed: 20210909 Latest Revision: 20210909

20240105

PMC8407584

10.1371/journal.pone.0256883

34464413