On 6 August 2012 a USAID press release announced that an agreement that reduces the cost of a rapid TB diagnostic test in 145 high-burden and developing countries.
Under the arrangement, organised by PEPFAR, USAID, UNITAID, and the Bill & Melinda Gates Foundation, the price of Xpert MTB/RIF cartridges will be reduced from $16.86 to $9.98 and will not increase before 2022.
To date, the high unit cost of Xpert MTB/RIF cartridges produced by the medical device manufacturer Cepheid has proven a barrier to their introduction and widespread use in low- and middle-income countries. The new agreement will immediately reduce the cost of cartridges used to diagnose TB by more than 40%.
In December 2010, the World Health Organization (WHO) recommended the Cepheid product, known as Xpert MTB/RIF assay, which is run on Cepheid’s GeneXpert platform. Until Cepheid developed the Xpert MTB/RIF assay, the only method used in most laboratories in developing countries was smear microscopy, a technique first developed in the 1880s by the German bacteriologist Robert Koch that requires visual detection of the TB bacterium under a microscope.
Smear microscopy is particularly insensitive for diagnosing TB in patients who are co-infected with HIV. It also does not help clinicians detect the presence of drug-resistant strains of TB. The limitations of traditional smear microscopy, along with the cost and long delays to receive culture results, have limited the ability to diagnose and treat TB and drug-resistant forms of the disease.
Xpert is a molecular diagnostic system that can detect TB disease in patients co-infected with HIV and resistance to the antibiotic rifampicin – a widely accepted indicator of the presence of multi-drug resistant TB – in less than two hours. The system also can be used outside of conventional laboratories because it is self-contained and does not require specialized training.
Because TB is the leading cause of death among people living with HIV in Africa, greater access to the Xpert test offers a significant advance in the capacity of health care workers to diagnose TB quickly and help reduce TB transmission, the development of TB disease, and premature TB deaths.
The capacity of the Xpert MTB/RIF assay to yield a rapid and accurate diagnosis has the potential to improve TB diagnosis and treatment in rural clinical settings. A large percentage of people with TB disease fail to start treatment promptly because of the long wait for results of older conventional tests and the need for them to return to the clinic, which may be far from where they live. Using the Xpert system, clinics in poor and rural settings can deliver rapid diagnosis and immediately start patients on appropriate treatment, including second-line drugs in cases of drug-resistant.
Research suggests that the incremental scale up of Xpert in countries with high TB burdens could allow for the rapid diagnosis of 700,000 cases of TB disease and save health systems in low- and middle-income countries more than U.S. $18 million in direct health costs.
The demands for lower cost access to this test have been widespread since the technology was first developed.
Even though $10 remains a significant cost in many settings, this news was widely welcomed.
Dr Lucica Ditiu, Executive Secretary of the Stop TB Partnership said “This agreement will translate into life-saving TB care for people affected by TB” and Dr Mario Raviglione, Director of the WHO Stop TB Department said “We see innovation happening in real time – scientific evidence rapidly translated into policy, policy quickly adapted into practice, and scale-up significantly accelerated by innovative funding mechanisms effectively addressing cost and affordability.”
The capacity for machines range from 4 to 100 tests and the cost was reduced from $60,000 to $17,000 when in 2007 when the price of cartridges for low and middle-income countries was initially reduced to $17 per test.
USAID press release. Public-private partnership announces immediate 40 percent cost reduction for rapid TB test. (6 August 2012).
Stop TB Partnership. Cost of Xpert cartridges to drop 40 percent. (6 August 2012).
Non-technical review on Gene Xpert