Cepheid (company)

Cepheid sells clinical tests for healthcare-associated infections, infectious diseases, sexual health, oncology and genetics.

[7] The GeneXpert test is basically an automated version of standard real-time PCR (polymerase chain reaction) amplification and detection.

[9][6] In 2003, the company put a temporary hold on some healthcare development to work with defense contractor, Northrop Grumman, on a U.S. federal government contract to install anthrax detection systems at US Post Office sites nationwide.

[11] The first clinical application for the GeneXpert System was introduced in 2006 with the U.S. FDA clearance of XpertGBS, a rapid molecular diagnostic test for Group B Streptococcus in expectant women.

[12] That same year, XpertGBS was categorized by the FDA as "Moderate Complexity"[13] under the Clinical Laboratory Improvement Amendments (CLIA).

[citation needed] In 2012, Cepheid won a contract with the U.S. Department of Veterans Affairs for its MRSA reagent test kits.

[19] The diagnostic is designed to run on any of the (over 23,000) existing Cepheid GeneXpert machines worldwide, with the standard 45 minute detection time.

[citation needed] In August 2012, a public-private partnership including the President's Emergency Plan for AIDS Relief, United States Agency for International Development, Unitaid, and Bill & Melinda Gates Foundation announced a subsidy plan that reduced the cost of GeneXpert MTB/RIF for TB testing from $16.86 to $9.98 in developing countries.

[24][23][26] The Treatment Action Group (TAG) seconded this request, saying that the development of the tests, and their purchase and global deployment, has been done with public funds, while the owners of Cepheid (Danaher Corporation) made profits of $3 billion in 2019.

They requested the same price reduction for all the tests using the same technique, including HIV, tuberculosis, and Hepatitis C, as the costs are similar regardless of the disease (see above).

[29][27] On September 12, 2023, a campaign was launched by author and vlogger John Green to continue the fight to lower the cost of TB cartridges to $5.

[30][31][32] One week later, Cepheid and Danaher announced a 20% price reduction for their Xpert MTB/RIF TB test cartridge, from $9.98 to $7.97 in high TB-burden countries.

[33][34] Cepheid was founded in March 1996 by Thomas Gutshall, Bill McMillan, Dr. Kurt Petersen, Dr. Greg Kovacs, Steven Young and Dr. Allen Northrup.

FISH testing, a standard techniqure for identifying pathogens, is done automatically by Cepheid's GeneXpert test systems
Tabular overview of public contributions to GeneXpert development. [ 1 ]
Public sector investments in GeneXpert development by source and year. Funding from non-NIH US government departments and non-profit/philanthropic organizations have been assumed to be equally distributed over a 5-year period to smooth out year-on-year changes. [ 1 ]
Tree-map of public investments