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$30 Million Research Effort to Develop New Tests for Deadly Infectious Diseases

Bill & Melinda Gates Foundation

GENEVA -- In response to the critical need for new tools to detect infectious diseases, the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Bill & Melinda Gates Foundation today announced a new initiative focused on developing new diagnostic tests for the world’s most deadly diseases. The Foundation for Innovative New Diagnostics (FIND) will work in collaboration with WHO/TDR, the diagnostics industry and other organizations to apply the latest biotechnology innovations to develop and validate affordable diagnostic tests for diseases of the developing world. The Gates Foundation has committed up to $30 million over the next five years to the initiative.

“The biotechnology advances of the past twenty years provide an opportunity to transform the way that we diagnose and treat disease in the world’s poorest countries,” said Dr Giorgio Roscigno, the new Executive Director of FIND. “We look forward to helping usher in a new generation of diagnostics that will greatly improve the tracking and treatment of deadly infectious diseases.”

There is an urgent need for more accurate and cost-effective diagnostic technologies, particularly for diseases of the developing world. While the biotech revolution has yielded important progress in the diagnosis and treatment of diseases that affect affluent societies, these advances have not been applied to diseases that kill millions each year in developing countries. As a result, many diseases go undetected and untreated in the developing world, accelerating their spread.

“The recent outbreak of SARS illustrates the need for easy-to-use and accurate diagnostics to aid in the control of infectious disease,” said Dr Carlos Morel, TDR director. “Great strides have been made in developing drugs and increasing patient access to good medicines, but diagnosis remains a stumbling block in public health. Public health needs can only be met through partnerships at all levels.”

Building on the accomplishments of TDR’s Tuberculosis Diagnostics Initiative, FIND will focus initially on TB, speeding up the development and evaluation of new tests to detect the disease, including drug resistant forms. TB was chosen as the first target for FIND because of the magnitude of the problem—one-third of the world’s population carries the TB pathogen—and the ability of existing health systems to treat cases once they are detected.

“We are 100 years behind in TB diagnostics. The technology and know-how is there, but it must be applied to the fight against infectious disease. A focused and coordinated effort that puts these technical advances to use for the public good can  ensure the speedy development of high quality and affordable tools.” Said Dr Mark Perkins, appointed as FIND’s Scientific Director. 

Today’s standard TB detection method, examining sputum under a microscope, was developed over a century ago.  It is time-consuming and frequently inaccurate.  While the success of the Global Drug Facility and other treatment programs have improved the access of TB patients to effective therapy, diagnostics are now recognized as a primary stumbling block in TB control and patient care.

Research carried out over the past two years by the TB Diagnostics Initiative in TDR showed that although TB and other diseases of the poor have been largely neglected by the bigger diagnostics companies, there is considerable diagnostic work going on in smaller biotechnology companies and academic research groups.  However, even when diagnostics are developed for infectious diseases, they do not always reach the public sector. FIND will also work with private industry, WHO, and other technical agencies to ensure that the tools in development match public health needs.

“What is missing is a coordinated mechanism to support new innovative efforts and to push these new and existing groups to develop and optimize tests that meet public needs, to evaluate the tests that emerge and to demonstrate their value in disease control,” said Perkins. This is what FIND will do, in close collaboration with WHO/TDR and national TB control programs.

“FIND will foster cooperation between private industry, the international health community, and the governments of affected nations,” said Dr Helene Gayle, former Director of HIV, TB, and Reproductive Health for the Bill & Melinda Gates Foundation. “This kind of public-private partnership is essential to bringing the latest health technologies to bear on the diseases of the developing world.”

TB kills one person every 15 seconds. The case fatality rate of TB is high, in large part because of lack of diagnosis and treatment. More sensitive diagnostics will open the possibility of treating the less contagious cases before they infect others. Faster, simpler diagnostics will make TB control efforts more effective, especially in places where patients have difficulty reaching health care.

TB is responsible for 5% of all deaths worldwide and 9.6% of adult deaths in the 15-59 age group. TB kills more women worldwide than all causes of maternal mortality. The disease is concentrated in low income countries. Some 80% of all TB cases are found in 22 countries, with more than half the cases occurring in five South East Asian countries. Nine out of 10 countries with the highest incidence rates are in Africa, where prevalent HIV infection has fuelled the epidemic and further complicated diagnosis.

FIND is an independent nonprofit foundation based in Geneva. The FIND secretariat will be governed by a board composed of public health experts, business leaders, influential scientists and patient representatives. A scientific advisory committee will provide scientific support to review proposals from both public and private collaborating parties FIND will work in close collaboration with WHO/TDR. Its nonprofit status will also enable FIND to work closely with industry to invest in the most promising diagnostics to meet public health needs.

In addition to developing and evaluating tests, FIND will fund demonstration projects to determine the potential impact of newly developed products and improve their use in developing countries. WHO/TDR will be a key player in the interaction with researchers, in setting up clinical trials and carrying on the implementation research required during the introduction of the new diagnostic tools by the health services of disease-endemic countries. FIND represents an expansion of TDR’s ongoing efforts to discover and develop diagnostics for neglected infectious diseases. In coordination with public health officials, the collaboration between WHO/TDR and FIND will ensure that appropriate technologies reach appropriate settings. FIND findings will provide input to the WHO on standard setting for diagnostics and regulatory harmonization.

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