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Working Group on New TB Drugs

Stop TB Partnership

WHO Endorses New Rapid Diagnostic Test for TB

WHO Press Conference

Yesterday, Mario Raviglione , Director of Stop TB, and Giorgio Roscigno, CEO of FIND, held a global press conference announcing the World Health Organization’s endorsement of the new rapid diagnostic test Xpert MTB/RIF.  If implemented to scale in countries where tuberculosis (TB) is endemic, it could revolutionize how TB is diagnosed and treated.  The test could have a significant impact on patients that are smear negative, HIV positive, or infected with drug-resistant TB.   

The implementation of the test into TB care and control is significant for several reasons:

  • Xpert is automated and can be used outside of conventional TB diagnostic infrastructures.  It has a closed system which removes the need for expensive and high tech bio-safety laboratories for TB testing. 
  • The test can be performed by a health worker instead of requiring a trained laboratory technician.
  • Xpert can diagnosis TB and the most difficult forms of TB (smear-negative, HIV+) within one hour and 40 minutes.  With current methods, diagnosis of TB has taken up to 2 months in a high tech lab. 
  • You can use the Xpert machine to detect several other pathogens in other poverty-related diseases.

Roscigno indicated that FIND, a non-profit who has been working on developing this technology for five years with partners, negotiated with the manufacturers for a 75% reduction in the commercial price of approx. $65.  The per unit price may be further reduced from $16.86 to $14 based on demand reaching 1.7 million units and $10 based on demand reaching 3.5 million.  This reduction is on the unit price of each cartridge for the Xpert machine.  This pricing should help in making the test accessible to low- and middle-income countries.  The machine  costs $17,000 not including shipping costs.  To alleviate the cost burden for countries to implement Xpert at scale, Roscigno anticipates funding to governments from PEPFAR, TB REACH (Stop TB), TB Care (USAID), World Bank, and others.   

Countries currently using Xpert in the private sector include South Africa, India, Pakistan.  FIND anticipates the volume estimates will be reached and the test implemented in the public sector of countries as a result of the WHO recommendations and endorsement.  Along with the endorsement, the WHO released a roadmap to guide and support countries in the adoption and implementation of Xpert at scale. 

Raviglione commented “It’s basically a development that the world has been waiting for, for literally decades.  It’s something that has the potential of truly revolutionizing the way we deal with TB today.”

Additional press coverage:

Slideshow of Press Conference

WHO

FIND

Stop TB Partnership

Advocacy to Control TB Internationally (Action)

Science Speaks:  HIV & TB News

Statement from Pepfar, USAID, CDC



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