New York, NY, June 26, 2024 — Treatment Action Group (TAG) calls on Danaher to lower the price of GeneXpert tests for tuberculosis (TB) and other diseases to $5 each in accordance with publicly available evidence of the cost of manufacturing and to commit to public transparency of the cost audit of Xpert MTB/RIF Ultra. Affordable diagnostic tests that are transparently priced are urgently needed to diagnose the more than 10 million people worldwide who get sick with TB each year, as well as for HIV, hepatitis, and other deadly diseases.
In September 2023, the investment corporation Danaher lowered the price of Xpert MTB/RIF Ultra—an essential test for diagnosing TB and resistance to rifampicin—to $7.97 per test following unprecedented pressure by the Time for $5 Campaign and TB activists around the world. Danaher, which owns GeneXpert manufacturer Cepheid, pledged to price the test at-cost for low- and middle-income countries and to not make any profit. To ensure this, Danaher committed to annual cost audits and to adjust the price of the test accordingly. But these actions must be fully transparent to satisfy TB civil society and affected communities. “Unless the cost audit methodology, data, and findings are transparent and made publicly available, any claims by Danaher regarding the cost of manufacturing the Xpert MTB/RIF Ultra test will not be credible,” cautions David Branigan, TAG Senior TB Project Officer.
Expanding access to TB diagnosis to find and treat the more than 3 million people around the world who go undiagnosed with TB each year is a longstanding goal of the TB community. In 2019, TAG and Médecins Sans Frontières Access Campaign launched the civil society-led Time for $5 Campaign, which has grown into a global movement calling for price reductions to enable more people with TB and other diseases to access essential GeneXpert tests. Public and philanthropic funders heavily subsidized the development of GeneXpert technology and the public should receive a return on this investment in the form of access to testing. Although Danaher reduced the price of Xpert MTB/RIF Ultra from $9.98 to $7.97 in 2023, the company continues to charge exorbitant prices for other GeneXpert tests: $15 for XDR-TB, HIV, HCV, HPV, and COVID-19 tests; between $16-19 for STI tests; and $20 for Ebola tests. The Time for $5 Campaign calls on Danaher to reduce the price of all GeneXpert tests to $5. Notably, the Xpert MTB/XDR test is currently the only rapid molecular test recommended by the World Health Organization (WHO) that is capable of diagnosing fluoroquinolone and isoniazid resistance in under two hours at decentralized levels of the healthcare system.
Danaher’s persistent monopoly on rapid molecular testing for TB must be addressed to protect TB programs and communities from these types of mercenary pricing schemes in the future. Investing in the development and roll out of additional rapid molecular TB tests is essential to establish a more competitive market to further lower prices and support country TB programs to scale up access to testing. GeneXpert is the most common rapid molecular test for diagnosing TB. However, Molbio’s Truenat, currently priced at $7.90 per test, is also recommended by the WHO. Uptake of Truenat has been slow due to its slightly more complex workflow and the familiarity of country TB programs with GeneXpert after more than ten years of investments in GeneXpert instruments. Truenat can be implemented in peripheral health centers closer to the point of care than GeneXpert, and researchers have shown that this important difference in instrument placement improves the speed of diagnosing TB and initiating treatment. Other rapid molecular TB tests from SD Biosensor and Bioneer that will be in more direct competition with Xpert MTB/RIF Ultra and Xpert MTB/XDR are in late development.
High prices of diagnostic tests limit the ability of country TB programs to deliver on ambitions to scale up access to testing necessary to close the TB diagnostic gap, a prerequisite to ending TB. Diagnostic tests should be priced transparently according to the cost of manufacturing plus a reasonable profit mark-up to achieve lowest sustainable pricing.
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