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GeneXpert Rapid TB Test Price Reduced in Historic Agreement

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tagline Fall 2012

by Coco Jervis

After months of political wrangling, in early July 2012, an agreement to reduce the price of the GeneXpert MTB/RIF rapid test for tuberculosis (TB) was reached between the manufacturer, Cepheid, and pooled purchasers UNITAID, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the United States Agency for International Development (USAID), and the Bill & Melinda Gates Foundation. GeneXpert was codeveloped by Cepheid, the Foundation for Innovative New Diagnostics (FIND), and the University of Medicine and Dentistry of New Jersey (UNMDJ). It accurately diagnoses both TB and some common rifampin drug-resistance mutations within two hours. The Xpertmolecular diagnostic system represents a major advance over microscopy, which has been the primary method of diagnosing TB for the last 125 years. The multi-stakeholder agreement represents the first in what should be a series of steps to accelerate market entry of the Xpert system. But the cost of the machines and cartridges remains high, and the lack of private-sector access greatly limits both the reach and impact of this historic agreement.

The agreement reduced the cost of individual Xpert cartridges by 40%, from US$16.98 to US$9.98 and froze the price from further increases until 2022. However, the price reduction for the cartridges will be applicable only to a set number of preapproved public-sector purchasers in resource-poor countries with high burdens of multidrug-resistant TB (MDR-TB) and TB/HIV coinfection. Middle-income countries in Eastern Europe and Asia with high TB burdens are currently excluded from this agreement. Moreover, the price of the diagnostic system itself is still unacceptably high at US$17,000 per device. Additional costs associated with recalibrating the machine make it unattainable in many TB-affected settings.

Widespread use of the Xpert test, which was endorsed by the World Health Organization in December 2010, could revolutionize the world’s fight against TB, as the test reduces the time to diagnosis for TB or suspected MDR-TB to two hours, from the weeks it takes for the standard TB culture to grow. As Mark Harrington, executive director of Treatment Action Group (TAG) and a longstanding TB activist, has noted, people with TB/HIV and MDR-TB are among those at greatest risk of death from TB. Delayed—or inaccurate-—diagnosis costs millions of dollars in undiagnosed or improperly treated TB, which sickened more than 8 million people and killed almost 1.4 million in 2010.

This collaborative market intervention is laudable, but more still needs to be done to increase access to the GeneXpert system. Further reductions in cartridge prices will be needed to maximize access to the test. TAG and our allies are calling on Cepheid to drastically reduce the price of the system itself to help ensure availability in resource-poor countries that are the hardest hit. Additionally, a tiered pricing system must be brokered that would enable private-sector providers in TB-endemic settings, as well as in middle-income countries, to have access to the system. Finally, a strategy to decentralize access to Xpert with more systemic integration into public health facilities on the ground is desperately needed.Over the past year, TAG has been working diligently with advocates to reduce the price of cartridges and to expand research advocacy and access for a point-of-care, rapid diagnostic for TB aspart of TAG’s new campaign calling for zero TB deaths, zero new TB infections, and zero TB suffering. More information about the declaration and the campaign is available www.treatmentactiongroup.org/tb/advocacy/zero-declaration.