CONTACT: David Branigan, TB Project Officer, david.branigan@treatmentactiongroup.org

March 17, 2023 — Treatment Action Group (TAG) applauds Molbio’s agreement with the Stop TB Partnership, USAID, and the Global Fund to reduce the price of Truenat diagnostic tests for tuberculosis (TB) from US$9 per test to $7.90 per test and to provide quality service and maintenance of Truenat testing instruments globally. While the lower price does not meet the $5 price target[*] for rapid molecular tests called for by the Time for $5 Coalition, it is the first price reduction of TB rapid molecular tests in over a decade.[†] Most importantly, the lower price will support scale up of rapid molecular TB testing. This is urgently needed to close the TB diagnostic gap—estimated at 40% of the global burden of TB—and to ensure that all people living with TB receive accurate diagnosis and are linked to effective TB treatment.

In 2020, Molbio’s Truenat rapid molecular TB test was recommended by the World Health Organization (WHO) and became the first competitor to Cepheid’s GeneXpert, breaking Cepheid’s decade-long monopoly on rapid molecular TB testing. The Truenat price reduction, announced last week by the Stop TB Partnership, offers the prospect of further competition with GeneXpert TB tests, which are priced higher at $9.98 per test, as well as opportunities for further decentralization of rapid molecular TB testing. The Truenat testing instrument is battery-powered and designed to be implemented in peripheral health centers, where the majority of people with TB present to care. GeneXpert, however, can only be operated in temperature-controlled and dust-free environments so is generally placed in district labs, requiring sample transport that often delays diagnosis and increases the risk that people being tested for TB will be lost to follow-up.

In addition to the price reduction, the negotiated deal with Molbio includes a standardized global level agreement to provide quality service and maintenance. Importantly, from TAG’s perspective, the quality of service and maintenance will be monitored according to key performance indicators, such as providing timely repairs and replacement of faulty parts so that downtime of testing instruments is minimized. This aspect of the agreement on service and maintenance reflects priorities defined in the Principles for Access to Multi-disease Molecular Diagnostics, put forward last year by TAG and Médecins Sans Frontières (MSF) Access Campaign. The Access Principles were developed through discussions between country program representatives, donors, members of civil society, and global health actors at the Roundtable on Access to Multi-disease Molecular Diagnostics in June 2022.

The Molbio agreement meets some, but not all, of the priorities defined in the Access Principles. Specifically, the agreement does not offer the option of all-inclusive pricing that covers the cost of instrument placement and service and maintenance within the price of the test; rather, Truenat tests, instruments, and service and maintenance warranties can only be purchased separately. Additionally, the Access Principles call for pricing based on full transparency and verifiable evidence of the cost of manufacturing; to TAG’s knowledge, Molbio has not yet shared this information publicly.

Molbio’s Truenat tests covered by the agreement include tests for TB and resistance to the first-line TB drug rifampicin, which are provided together as a bundle for the same $7.90 price. All public sector buyers can purchase these tests along with Truenat instruments and service and maintenance warranties from the Stop TB Partnership Global Drug Facility. Notably, Molbio has committed to offering private sector buyers similar prices—a welcome move that is aligned with the Access Principles.

Molbio is currently developing TB tests optimized for tongue swab samples, rather than sputum, as well as tests for resistance to isoniazid and fluoroquinolones, which are critical for rapidly detecting resistance to these core TB drugs to ensure that people diagnosed with TB are immediately linked to the most effective treatment regimens. It is unclear how Molbio will price these new tests in development, but TAG urges Molbio to align future pricing with the Access Principles. One challenge with Truenat TB tests is the limited data on the accuracy of these tests using non-sputum samples, such as stool, nasopharyngeal aspirate, and gastric aspirate, which are essential for diagnosing pediatric TB, so more research is needed.

The significant gap in access to rapid molecular testing for TB and drug resistance stands as one of the largest shortfalls in the global TB response today. WHO estimated that in 2021 4.2 million people with TB (40%) were missed by the health system, and of the estimated 450,000 people who developed drug-resistant TB (DR-TB), just one in three received follow-on drug susceptibility testing and were linked to DR-TB treatment. WHO recommended rapid molecular tests as the initial TB test for all in 2013, yet in 2023 many high-TB-burden countries continue to rely on smear microscopy as the initial TB test, an outdated technology that is only about 50% sensitive for detecting TB. Closing the TB diagnostic gap by scaling up access to rapid, accurate TB testing is a prerequisite for expanding access to TB treatment.

Decades of scientific research have resulted in shorter, safer WHO-recommended regimens for TB prevention and treatment, but very few people around the world have access to them. In 2022, TAG and partners launched the 1/4/6×24 Campaign demanding that country governments and other duty bearers scale up access to one-month or once-weekly regimens for TB prevention, four-month regimens for drug-sensitive TB (DS-TB), and six-month regimens for DR-TB, by the end of 2024. All people living with TB or at risk of TB have a right to benefit from scientific progress and to have access to rapid, accurate diagnosis and the shortest and best available TB treatment regimens. By putting in place what the late Dr. Paul Farmer called the “five S’s”—the staff, stuff, space, systems, and support—needed to facilitate access to the latest WHO-recommended technologies, yes, we can end TB.

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[*] The $5 price target is based on a Médecins Sans Frontières analysis of the cost-of-goods-sold (COGS) of Cepheid’s GeneXpert tests: https://msfaccess.org/time-for-5

[†] In 2012, the World Health Organization, Unitaid, USAID, PEPFAR, and the Bill & Melinda Gates Foundation entered into a buy-down agreement to pay Cepheid $11.1 million to reduce the price of GeneXpert tests for TB and resistance to rifampicin from $16.86 to $9.98 for a period of ten years for 145 low- and middle-income countries: https://www.treatmentactiongroup.org/publication/advancing-access-through-market-interventions-lessons-learned-from-the-genexpert-tuberculosis-test-buy-down/