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December 2010

WHO endorses new rapid test for TB and drug resistance

December 8, 2010 -- The World Health Organization (WHO) today announced that it has endorsed a new test for tuberculosis (TB) and rifampicin drug resistance. The new Xpert®MTB/RIF test was co-developed by the Foundation for Innovative New Diagnostics (FIND), which worked in conjunction with the WHO and several other groups, including Cepheid, the University of Medicine and Dentistry of New Jersey, the Bill & Melinda Gates Foundation, and the US National Institutes of Health (NIH). Development of the new diagnostic highlights the crucial role of a range of partners—including the WHO, product development partnerships such as FIND, academia, manufacturers, and the US Government—in spurring global health research.

The test has the potential to revolutionize TB care and control in the countries and populations most affected by the disease. It provides an accurate diagnosis for many patients in about 100 minutes, compared with current tests that can take up to three months to obtain results.

FIND also announced that it has negotiated with the manufacturer, Cepheid, a 75 percent reduction in the price for countries most affected by TB, compared with the current market price. Preferential pricing will be granted to 116 low- and middle-income countries where TB is endemic, with additional reduction in price once there is significant demand. "There has been a strong commitment to remove any obstacles, including financial barriers, that could prevent the successful roll-out of this new technology," said Giorgio Roscigno, FIND's chief executive officer. "For the first time in TB control, we are enabling access to state-of-the-art technology simultaneously in low-, middle-, and high-income countries. The technology also allows testing of other diseases, which should further increase efficiency.”

Following WHO’s endorsement, the organization is calling for the new diagnostic to be rolled out under clearly defined conditions and as part of national plans for TB and multi-drug resistant TB care and control. In addition, WHO is releasing recommendations and guidance for countries to incorporate this test in their health programs. "This new test represents a major milestone for global TB diagnosis and care. It also represents new hope for the millions of people who are at the highest risk of TB and drug-resistant disease,” said Mario Raviglione, director of WHO's Stop TB department. He added, "We have the scientific evidence, we have defined the policy, and now we aim to support implementation for impact in countries.” See the links below for more details.

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