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Catalysis Foundation for Health Receives $5 Million Grant For Tuberculosis Diagnostic Biomarker Research

Emeryville, CA-February 10, 2010—The Catalysis Foundation for Health (Catalysis), a 501 (c) (3) non-profit entity dedicated to developing sustainable diagnostics for the developing world, announced today that it has received a $5 million grant from the Bill & Melinda Gates Foundation. The grant money will be used to discover new tuberculosis (TB) biomarkers that can be used to improve diagnostic tests and potentially develop more effective TB treatments.

To date, efforts to develop effective treatments against TB have been hindered by an inability to precisely and rapidly measure the efficacy of TB therapies. Current methods, based on sputum cultures, are difficult to perform and generate imprecise clinical endpoints, contributing to the length and cost of clinical trials.

Catalysis’ biomarker identification initiative is designed to have major global public health applications. Its research efforts will focus on collecting and analyzing a comprehensive set of samples from TB patients in several countries. Scientists will use these samples to identify and apply biomarkers for use in next-generation “bacterial load” diagnostic assays, analogous to HIV viral load assays so effectively used in managing AIDS patients. These “bacterial load” assays, which measure the amount of bacteria in the body, could also lead to a more rapid, precise and efficient approach to developing effective TB drugs by providing a better indication of a patient’s response to treatment.

“The Catalysis Foundation’s initiative is an important opportunity to address a critical need in tuberculosis drug development and disease management by developing quantitative measures of bacterial burden,” said Clifton E. Barry, III, PhD., Chief, Tuberculosis Research Section, National Institute of Allergy and Infectious Diseases, and a Catalysis collaborator on the new study. “Our goal is to provide new diagnostic tools to facilitate disease diagnosis, monitoring and treatment in remote geographic settings to help patients lead healthier lives free of the deadly disease caused by TB infection.”

About the Research Project and the Catalysis Foundation’s Mission

To fulfill its mission of bringing advanced diagnostic products to developing nations, the Catalysis Foundation is building a coalition of experts representing tuberculosis and infectious disease research and development, global public health, government and non-governmental organizations, the pharmaceutical industry and funders to accelerate the transition from discovering TB biomarkers to speeding life-saving therapeutics to patients in need.

Catalysis will collect and analyze thousands of biofluid samples from patient populations in multiple countries to identify nucleic acid and lipid biomarkers that correlate directly with the infected individual’s “bacterial load.” Samples from several different biofluids will be collected and correlated with clinical measurements and patient status. These discoveries will lead to the future development of novel, validated assays to guide more targeted and effective diagnosis, treatment and outcomes.

The results of Catalysis’ biomarker identification initiative will have global public health applications: the enhanced ability to rapidly assess treatment efficacy; improved targeting of therapy; and, potentially, an acceleration of clinical trials for TB drugs and vaccines.

“Catalysis is forging a new model in private/public partnerships to attract the funding and amass the talents and technologies necessary to facilitate the development of life-saving, sustainable diagnostics to address major healthcare challenges,” said David Ho, MD, Chief Executive Officer, Aaron Diamond AIDS Research Center. “ADARC is pleased to have supported the Foundation’s establishment and believes their work in leveraging the tools of science, technology, and commerce to eradicate disease will improve human health in emerging countries.”

“Our Foundation’s mission is to develop innovative diagnostic tools to accelerate the worldwide effort to eliminate deadly infectious diseases such as tuberculosis which are ravaging populations in developing countries,” said Richard Thayer, Chief Executive, Catalysis Foundation for Health. “Along with therapeutics and vaccines, diagnostics make up the critical and often overlooked ’third imperative’ for reducing the burden of disease. By establishing a global coalition of experts with skills in every aspect of diagnostics product development and commercialization, together we can realize our shared goal to create long-term, sustainable solutions for resource-poor settings.”

Tuberculosis: A Global Epidemic

Tuberculosis (TB) is an infectious disease caused by a bacterium called Mycobacterium tuberculosis. The bacterium spreads from person to person through the air. One-third of the world’s population is infected with the TB bacterium, but only 5 to 10 percent of those infected become sick or contagious. Progress is being made, but TB is still one of the leading causes of death from an infectious disease worldwide, and a major killer of people living with HIV/Acquired Immune Deficiency Syndrome (AIDS). About 1.8 million people died from TB in 2007, including 456,000 people living with HIV. Ninety percent of all cases and deaths occur in developing countries. The economic impact of TB for developing countries is also huge. It is estimated that high-burden countries in Asia suffer from productivity loss due to TB of 4 to 7 percent of GDP per year. [Source: The Bill & Melinda Gates Foundation website: http://www.gatesfoundation.org]

About Catalysis Foundation for Health

The Catalysis Foundation for Health, founded in 2007, is committed to alleviating the gaps in healthcare caused by inadequate or unavailable diagnostic technologies in developing countries. Catalysis is applying expertise and best practices from the global diagnostics industry to create long-term, sustainable solutions for resource-poor settings. Through creation and participation in collaborative networks that bring together public, private, industry, and governmental stakeholders, Catalysis is helping to identify and quantify unmet needs, develop enabling technologies and ensure that innovative, well-designed, high-quality and affordable healthcare products are developed and delivered to patients and health practitioners. Through these collaborative efforts, Catalysis is realizing its vision to combat and eliminate major diseases worldwide. For more information, please visit www.catalysisfoundation.org.