The high cost of GeneXpert tests for TB leaves open a critical gap in the diagnosis of TB and fails to consider volume of sales and public investments in the development of GeneXpert.
Hyderabad, India – October 31, 2019 – Activists disrupted a session at the 50th Union World Conference on Lung Health to demand that the diagnostics corporation Cepheid halve the price of its tuberculosis (TB) tests GeneXpert MTB/RIF and MTB/RIF Ultra to US$5.
A lower price of $5 per test, inclusive of service and maintenance costs, will enable countries to afford to scale up GeneXpert MTB/RIF and MTB/RIF Ultra as the initial test for diagnosing TB, as recommended by the World Health Organization (WHO). In the absence of affordable GeneXpert cartridges, many countries continue to rely on the much less accurate but more affordable method of sputum smear microscopy, leaving open a persistent and deadly gap in TB diagnosis. According to the WHO, current volumes of GeneXpert tests have to be expanded 10-fold in order to provide access to all people that need testing for TB in the 30 high burden countries.
The Global Coalition of TB Activists (GCTA), Médecins Sans Frontières (MSF) and Treatment Action Group (TAG) were among the organisations that signed on to an open letter, endorsed by 127 organisations and individuals, demanding that Cepheid lower the price of GeneXpert tests to $5, inclusive of service and maintenance. At the conference, advocates disrupted a session on GeneXpert, delivered an over-sized version of the open letter to Cepheid representatives, and occupied the Cepheid booth.
“Substantial public and philanthropic funding supported the development of GeneXpert TB tests, and now the public is paying twice to access these essential tests at a high price,” said David Branigan, TB Project Officer at Treatment Action Group. “It is time that the public receives a larger return on this investment, and that Cepheid lowers the price of Xpert tests to $5 per cartridge, inclusive of service and maintenance.”
Since 2012, the cost of GeneXpert tests in the public sector have been locked into the price of $9.98 per cartridge, which was the result of a buy-down agreement in which Unitaid, the United States government, and the Bill & Melinda Gates Foundation paid Cepheid $11.1 million to reduce the price of GeneXpert cartridges from $16.86. At current annual volumes of nearly 12 million tests sold in the public sector alone, Cepheid’s manufacturing costs are estimated to be as low as $3 per cartridge, according to MSF. This low manufacturing cost leaves room to include a comprehensive service and maintenance plan as well as a reasonable markup within the $5 cost of each cartridge.
“It is the right of all people at risk of developing TB to be tested with the most effective tests,” said Blessina Kumar, CEO of the Global Coalition of TB Activists. “Cepheid’s TB tests should be made affordable. It is time that Cepheid start prioritising people over profit, and become accountable to communities affected by TB by lowering the price of GeneXpert tests to $5.”
“It is critically important for doctors and nurses in the field to be able to rapidly diagnose people with TB or multidrug-resistant TB in order to treat them quickly and effectively. Access to affordable Xpert cartridges would go a long way in finding the millions of missing TB patients who continue to remain undiagnosed and are unable to access treatment,” said Dr. Vivian Cox, TB Advisor at MSF. “Lowering the price of GeneXpert cartridges to $5 will greatly help in closing the deadly gap in diagnosis of the world’s leading infectious killer.”
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About the Global Coalition of TB Activists (GCTA): GCTA is a global platform for those affected by TB to make their voices heard at every level. GCTA is composed of regional, national, and sub-national coalitions of TB advocates, including Activists Coalition on TB – Asia-Pacific (ACT AP) in the Asia-Pacific region, Activists Coalition on TB in the Africa region, TB People in Europe, and Red de Personas Afectadas por Tuberculosis en Latino América y El Caribe (REDTBLAC) in the Americas. Since its inception in 2013, the GCTA has contributed significantly to the global TB agenda through its network of over 300 members affected by TB.
About Médecins Sans Frontières (MSF): MSF is an emergency medical humanitarian organisation that provides medical assistance to people affected by conflict, epidemics, disasters, or exclusion from healthcare. MSF has been involved in TB care for over 30 years, often working alongside national health authorities to treat patients in a wide variety of settings, including chronic conflict zones, urban slums, prisons, refugee camps and rural areas. MSF has TB treatment projects in 30 countries; it is one of the largest non-governmental providers of treatment for drug-resistant TB.
About Treatment Action Group (TAG): TAG is an independent, activist, and community-based research and policy think tank fighting for better treatment and prevention, a vaccine, and a cure for HIV, TB, and hepatitis C virus (HCV). TAG works to ensure that all people with HIV, TB, and HCV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions.
About GeneXpert and Xpert tests: Xpert MTB/RIF and Xpert MTB/RIF Ultra are rapid molecular nucleic acid amplification tests (NAATs) that are run using the GeneXpert testing platform. Xpert MTB/RIF and Xpert MTB/RIF Ultra are capable of diagnosing TB with a high sensitivity of 85% and 88%, respectively, as compared to the average sensitivity of sputum smear microscopy at just 50%. The WHO recommended Xpert MTB/RIF in 2011 and Xpert MTB/RIF Ultra in 2017 as the initial test for TB diagnosis. Since 2012, the volumes of sales of GeneXpert tests increased dramatically from 1.3 million to nearly 12 million cartridges sold in 2018 to the public sector alone. Cepheid developed the GeneXpert testing platform and Xpert MTB/RIF tests over the past two decades with substantial public and philanthropic funding, which included an estimated $120 million from the US Department of Defense, $45 million from the US National Institutes of Health (NIH), and over $20 million via the Foundation for Innovative New Diagnostics (FIND), with funding largely from the Bill & Melinda Gates Foundation.
- World Health Organization. Policy statement: automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system. Geneva: World Health Organization; 2011. https://apps.who.int/iris/bitstream/handle/10665/44586/9789241501545_eng....
- TB stakeholders. OPEN LETTER: Time to Lower the Price of Xpert Cartridges to US$ 5. 2019 October 21. Available from: http://www.tbonline.info/media/uploads/documents/open_letter_cepheid.pdf.
- Cambridge Consultants. Cost of goods and manufacturing analysis of GeneXpert cartridges. Independent report commissioned by Médecins Sans Frontières; 2019 March.
- Horne DJ, Kohli M, Zifodya JS, et al. Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews [Internet]. 2019 Jun 7 (cited 2019 Oct 27);2019(6):CD009593. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6555588/.
- World Health Organization. Approaches to improve sputum smear microscopy for tuberculosis diagnosis: expert group meeting report. Geneva: World Health Organization; 2009. http://www.stoptb.org/wg/gli/assets/documents/EGM%20Report%20on%20Micros....
- World Health Organization. Next-generation Xpert MTB/RIF Ultra assay recommended by WHO [Internet]. 2017 March 24 (cited 2019 Oct 27). https://www.who.int/tb/features_archive/Xpert-Ultra/en/.
- Médecins Sans Frontières and Stop TB Partnership. Out of Step 2017: TB policies in 29 countries. A survey of prevention, testing and treatment policies and practices. 3rd ed. 2017 Jul 4. MSF Access Campaign. https://msfaccess.org/sites/default/files/MSF_assets/TB/Docs/TB_Report_O....
- Technical Officer (Stop TB Partnership Global Drug Facility, Geneva, Switzerland). Personal communication with: David Branigan (Treatment Action Group, New York, NY). 2019 Oct 8.
Source: Treatment Action Group