WHO, Stop TB Partnership, UNITAID announce new tuberculosis test that quickly diagnoses MDR-TB

The World Health Organization, Stop TB Partnership, UNITAID and the Foundation for Innovative New Diagnostics on Monday announced a joint project to distribute a new diagnostic test for multi-drug resistant tuberculosis that can produce results in two days instead of the standard two or three months, the New York Times reports. Difficulty in identifying MDR-TB has been a "major obstacle" in controlling TB because many patients die or spread the disease while waiting for test results, the Times reports.

According to the agencies, the test can lead to improved treatment of MDR-TB and prevent further spread of the disease. WHO estimates that 5% of new TB cases annually are MDR-TB (Altman, New York Times, 7/1). However, the new test is unable to diagnose extensively drug-resistant TB, or XDR-TB, and the test cannot be used for patients who cannot cough up sputum or who appear to have no bacteria in their sputum, according to Tido von Schoen-Angerer of Medecins Sans Frontieres. About half of people with HIV/TB coinfection are "sputum negative," meaning that the new test will not work for them, the AP/Miami Herald reports (Jordans, AP/Miami Herald, 6/30).

The $60 million project will take place in two phases over four years (Chase, Wall Street Journal, 7/1). The company also is developing a test to diagnose extensively drug-resistant TB, Reuters reports. XDR-TB is resistant to the two most potent first-line treatments and at least two of the classes of second-line drugs (MacInnis, Reuters, 6/30).

The accuracy of the new test is equal or superior to currently available tests, Mario Raviglione, director of WHO's Stop TB Department, said (Wall Street Journal, 7/1). "The new test is revolutionary" because it "changes completely the way we will be dealing with MDR-TB," Raviglione said. Versions of the test have been licensed in Canada, several European countries and Japan; however, the test has not been approved in the U.S. (New York Times, 7/1).

Project Phases

Under the first part of the project, the Stop TB Partnership will distribute the tests to 16 developing countries, using $26 million in funding from UNITAID. WHO and FIND will assist the countries in implementing the tests (Fagan, Washington Times, 7/1). The tests will cost $20 each, compared with $34 for older tests. The test will first be distributed in Lesotho and then in Cote d'Ivoire, the Democratic Republic of Congo and Ethiopia by the end of 2008, Raviglione said (AP/Miami Herald, 6/30). Twelve other countries -- Azerbaijan, Bangladesh, Georgia, Indonesia, Kazakhstan, Kyrgyzstan, Moldova, Myanmar, Tajikistan, Ukraine, Uzbekistan and Vietnam -- will receive the test over the next four years (Reuters, 6/30).

Under the second part of the project, the Stop TB Partnership will increase the supply of drugs used to treat drug-resistant TB in 54 countries, including the 16 countries receiving the test (Washington Times, 7/1). According to WHO, the project should increase the percentage of MDR-TB cases that are properly diagnosed and treated from 2% to 15% (Reuters, 6/30).