Abstract
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. 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. 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. 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.
Highlights
The development of molecular diagnostics in the 1990s represented a significant medical advance
The GeneXpert diagnostic platform is a rapid, automated polymerase chain reaction (PCR) device that does not require a fully equipped modern laboratory. These characteristics are especially valuable in improving access to molecular diagnostics in healthcare settings where well-equipped laboratories are scarce, or where it is important to provide a diagnosis within hours near the point of care, rather than waiting days to weeks using conventional methods
We recently investigated the public sector investments in developing bedaquiline, a key new treatment for drug-resistant tuberculosis, and reported that the public sector has invested $455–747 million in the drug’s development, estimated to be 1.6–5.1 times the investments made by the proprietor pharmaceutical company [13]
Summary
The development of molecular diagnostics in the 1990s represented a significant medical advance. The GeneXpert diagnostic platform is a rapid, automated PCR device that does not require a fully equipped modern laboratory. 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 widely used in low- and middle-income countries for diagnosis of diseases such as TB and HIV. We aimed to quantify public sector investments in the development of the GeneXpert platform and Cepheid’s suite of cartridge-based assays
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