History
The key engineering innovations underlying GeneXpert technologies, as well as early versions of the product and field testing, were done at the Lawrence Livermore National Laboratory at the University of California. It was funded by the microelectromechanical systems (MEMS) program of the DARPA and the U.S. Army, as well as through LLNL's internal budget.[1]
Cepheid was founded in 1995 and mainly funded by the US military until the 2001 anthrax attacks.[1] It had received $15 million in Defense Department research and development money prior to the attacks.[7]
During the 2001 anthrax attacks, U.S. federal agencies contracted with Cepheid to track the anthrax.[8][5] 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.[9]
Cepheid won the 2006 Industrial Design Excellence Awards for its product, Reagent Bead Dispenser.[10]
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.[11] That same year, XpertGBS was categorized by the FDA as "Moderate Complexity"[12] under the Clinical Laboratory Improvement Amendments (CLIA). It was the first amplified molecular diagnostic test using real-time PCR to receive this categorization.[13] This allowed the test to be performed by the over 27,000 institutions registered for CLIA Moderate Complexity in addition to the approximately 7,000 institutions registered for High Complexity tests.
In 2012, Cepheid won a contract with the U.S. Department of Veterans Affairs for its MRSA reagent test kits.[14]
As of March 31, 2014, Cepheid markets 14 U.S. FDA-cleared clinical in vitro diagnostic (IVD) tests in the U.S. and 16 IVD tests internationally and has placed 6,012 GeneXpert systems globally.[15] As of, there are over 23,000 GeneXpert machines globally, 7,000–10,000 of them in Africa, Latin America and South-East Asia, with over a hundred in some African countries, due to long-term investment in tuberculosis-testing infrastructure by The Global Fund, among others.[16]
During the COVID-19 pandemic, Cepheid announced a partnership with Sherlock Biosciences in February 2020 to begin development of a CRISPR-based diagnostic test for the SARS-CoV-2 (then called "2019-nCov") virus,[17] to run on the same machines as Cepheid's 20-year-old GeneXpert tests, as there were machines already installed in hospitals.[5] In March 2020, the company announced a rapid diagnostic test for SARS-CoV-2; the U.S. FDA granted an emergency use authorization for the test.[18] 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.[19]
