Lifesaving Breakthrough in Diagnosing Drug-Resistant TB

Victims of Multi-drug Resistant Tuberculosis (MDR-TB) in developing countries will now be able to get a faster diagnosis that will offer a higher chance of survival and help to protect against the spread of the disease to others who may come in contact with them. Two initiatives made public by the World Health Organization (WHO), Stop TB Partnership, UNITAID, and the Foundation for Innovative New Diagnostics (FIND) will allow for diagnosis of the MDR-TB to be confirmed within two days instead of taking the standard time of two to three months, and will also pave the way for appropriate treatment to be administered more quickly than ever before.

Globally, more than 9 million people contract tuberculosis every year. Of those, almost 500,000 will get MDR-TB, which kills almost 130,000 people annually. This form of TB has little response to standard treatment for the disease due to its resistance to the first-line drugs isoniazid and rifampicin. MDR-TB can develop in the course of the treatment of fully sensitive TB resulting from patients missing doses or failing to complete a course of treatment. MDR-TB has a mortality rate comparable to lung cancer. People who have weakened immune systems because of diseases such as HIV or from the use of drugs are more susceptible to contracting TB.

It is estimated that currently only 2 percent of worldwide MDR-TB cases are getting diagnosed and treated properly, with the main culprit being laboratory services. Currently, TB patients in developing countries are tested for MDR-TB only if they fail to respond to standard treatments. Once tested, it takes two months or longer to confirm the diagnosis, leaving patients to wait to receive lifesaving second-line drugs. While waiting for test results, these patients can spread MDR-TB to others or even die before results are known. Patients who are HIV-infected in addition to having MDR-TB have an especially increased risk of death while awaiting test results.

With the new initiatives, diagnosis and treatment of MDR-TB are expected to increase in proportion to 15 percent or more within four years. The first of two projects proposed includes new molecular and rapid tests to diagnose MDR-TB, known as line-probe assays, which will produce an answer in less than two days. The development of these tests was funded with $26.1 million from UNITAID, 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.

Over the course of the next four years, 16 countries will start using the molecular and rapid tests to diagnose MDR-TB as lab staff gets trained and lab facilities are enhanced with new equipment deliveries. The Stop TB Partnership's Global Drug Facility will provide the tests. The Stop TB Partnership was established in 2000 to realize the goal of eliminating TB as a public health problem and, ultimately, to obtain a world free of TB. It comprises a network of international organizations, countries, donors from the public and private sectors, governmental and nongovernmental organizations and individuals that have expressed an interest in working together to achieve this goal.

WHO's Global Laboratory plan and FIND will assist in the preparations for installation and use of the new rapid diagnostic tests, make sure bio-safety technical standards are followed and ensure capacity for accurately performing DNA-based tests. WHO is the directing and coordinating authority for health within the United Nations system while FIND is dedicated to the development of rapid, accurate and affordable diagnostic tests through public-private partnerships.

The first country to receive the tests, Lesotho, is currently equipped to begin using them and Ethiopia is expected to be ready by the end of this year. The 14 remaining countries will be phased in from 2009-2011.

The second project in the initiatives will also be funded by UNITAID in the amount of $33.7 million. The Global Drug Facility will use the funds to boost the drug supplies needed to treat MDR-TB in a total of 54 countries. In addition, the project is expected to realize price reductions of up to 20 percent for second-line drugs for treatment of TB by the year 2010.

"Through the $60-million support provided by UNITAID, these projects are expected to produce significant results in diagnosing and treating patients as well as reducing drug prices and the costs of diagnosis. These efforts illustrate the way in which innovative financing can be deployed for health and development," said Philippe Douste-Blazy, Chairman of UNITAID's Executive Board.