Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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Wall Street Journal - July 1, 2008
Marilyn Chase, marilyn.chase@wsj.com
The WHO and UNITAID, a multinational funding partnership backing disease response in poor countries, said $26.1 million will be available to roll out the test in 16 developing countries over the next four years, starting with Lesotho and Ethiopia. The South African government is expected to endorse the test Tuesday.
The new diagnostic test -- called a line-probe assay -- is made by Germany's Hain Lifescience GmbH, and uses a technology known as polymerase chain reaction, or PCR, to identify genes linked with resistance to two first-line TB drugs, rifampin and isoniazid.
The information will enable doctors to more quickly start treatment, quelling the bug's spread.
Mario Raviglione, director of the WHO's Stop TB Department, said the agency endorsed the genetic test as equal or superior in accuracy to the century-old culture tests currently used around the world. While it hasn't been approved by U.S. regulators, the test should be considered by all countries, said Richard O'Brien, head of product evaluation for the Foundation for Innovative New Diagnostics, a Geneva-based foundation working with the WHO.
TB is a highly contagious illness that affects the lungs, and is characterized by fever, cough and difficulty breathing. It sickened 9.2 million people and killed 1.7 million world-wide in 2006, according to the WHO, making it the world's second-most-fatal infectious disease after AIDS. TB's mounting drug resistance makes it hard to diagnose and treat, and increases chances of it being transmitted.
WHO officials said several research groups are developing a test to catch more extensively drug-resistant TB.
The WHO estimates only 2% of multidrug-resistant TB cases are being diagnosed and treated appropriately because of inadequate laboratory facilities. Expanding the new test will boost diagnostic capacity to 15%, but Mr. Raviglione said $170 million is needed to build sufficient lab capacity.
A companion agreement with UNITAID will provide $33.7 million for drugs to treat the illness in 54 countries.
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