A new revolution to control TB through a DNA test, health officials say

By KUNA,

Geneva : A senior World Health Organization (WHO) official Dr. Mario Raviglione said Monday that a revolution is accomplished by allowing people in low-resource countries who are ill with multidrug-resistant TB (MDR-TB) to get a faster diagnosis — in two days, not the standard two to three months.


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In developing countries most TB patients are tested for MDR-TB only after they fail to respond to a standard treatments. Even then, it takes two months or more to confirm the diagnosis. Patients have to wait for the test results before they can receive life-saving second-line drugs. During this period, they can spread the multidrug-resistant disease to others. Often the patients die before results are known, especially if they are HIV-infected in addition to having MDR-TB. The initiative comes just one week after WHO recommended “line probe assays” for rapid MDR-TB diagnosis worldwide. This policy change was driven by data from recent studies, including a large field trial-conducted by Stop TB Partnership, UNITAID and the Foundation (FIND) together with South Africa’s Medical Research Council and National Health Laboratory Services–which produced evidence for the reliability and feasibility of using line probe assays under routine conditions. The new revolution is a result of two new initiatives unveiled today by the World Health Organization (WHO), the Stop TB Partnership, UNITAID and the Foundation for Innovative New Diagnostics (FIND).

UNITAID is an international drug purchase facility, established to provide long-term, sustainable and predictable funding to increase access and reduce prices of quality drugs and diagnostics for the treatment of HIV/AIDS, malaria and tuberculosis in developing countries.

MDR-TB is a form of TB that responds poorly to standard treatment because of resistance to the first-line drugs isoniazid and rifampicin. At present it is estimated that only 2 percent of MDR-TB cases worldwide are being diagnosed and treated appropriately, mainly because of inadequate laboratory services. The initiatives announced today should increase that proportion at least seven-fold over the next four years, to 15 percent or more.

The new initiative consists of two projects. The first, made possible through USD 26.1 million in funding from UNITAID, will introduce a molecular method to diagnose MDR-TB that until now was used exclusively in research settings. These rapid, new molecular tests, known as line probe assays, produce an answer in less than two days. Over the next four years — as lab staff are trained, lab facilities enhanced and new equipment delivered — 16 countries will begin using rapid methods to diagnose MDR-TB, including the molecular tests. The countries will receive the tests through the Stop TB Partnership’s Global Drug Facility, which provides countries with both drugs and diagnostic supplies.

The 16 countries are: Azerbaijan, Bangladesh, Cote d’Ivoire, the Democratic Republic of Congo, Ethiopia, Georgia, Indonesia, Kazakhstan, Kyrgyzstan, Lesotho, Republic of Moldova, Myanmar, Tajikistan, Ukraine, Uzbekistan, Viet Nam As part of the project, WHO’s Global Laboratory Initiative and FIND will help countries prepare for installation and use of the new rapid diagnostic tests, ensuring necessary technical standards for biosafety and the capacity to accurately perform DNA-based tests. One country, Lesotho, is already equipped to start using these tests; Ethiopia is expected to be ready by the end of 2008. The tests will be phased in from 2009-2011 in the remaining 14 countries.

Under a second, complementary agreement with UNITAID for USD 33.7 million, the Global Drug Facility will boost the supply of drugs needed to treat MDR-TB in 54 countries, including those receiving the new diagnostic tests. This project is also expected to achieve price reductions of up to 20 percent for second-line anti-TB drugs by 2010. Chief Executive Officer of the Foundation for Innovative New Diagnostics ()Dr. Giorgio Roscigno, said that the test will cost USD 5, and some USD 50, 000 for a new equipped lab. It is expected that the global efforts will lead to the eradication of TB by 2015 by eliminating the disease in 1.6 million people.

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