Breath test for tuberculosis under development at CSU with Gates Foundation funding

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Tuberculosis researchers at Colorado State University have landed a grant from the Bill and Melinda Gates Foundation to develop a diagnostic breath test with potential to revolutionize TB testing and to better control the globally devastating infectious disease.

A breath test represents a critical advancement over existing diagnostics, which are invasive, slow, and sometimes inaccurate in diagnosing TB. The infectious disease causes an estimated 1.5 million deaths worldwide each year, making it one of the world’s leading causes of death.

Of an estimated 9 million people who become sick with TB each year, some 3 million will go undiagnosed – in large part because a simple and affordable test is not available, said Diane Ordway, the CSU researcher leading development of the breath test.

“They die without being treated,” Ordway said, noting that the disease is most severe in parts of Asia and Sub-Saharan Africa. “This is a pathogen of poverty.”

The breath-test project, supported by a $244,000 grant from the Bill and Melinda Gates Foundation’s Global Health Program, also involves Randall Basaraba and Alan Schenkel in CSU’s renowned Mycobacteria Research Laboratories.

During the past six years, the Gates Foundation has provided researchers in the CSU Mycobacteria Research Laboratories with 14 grants totaling nearly $11 million. Like earlier CSU projects with Gates funding, this one aims to save lives by tackling one of the developing world’s most intractable diseases.

“One of the most significant challenges in controlling the spread of TB is early diagnosis,” Ordway said. “Despite decades of effort, no progress has been made in developing validated biomarkers, or measurable indicators, for identifying initial TB infection and the progression of infection to early disease.”

CSU scientists are collaborating with Dr. Michael Phillips and Dr. Peter Kaplan of Menssana Research Inc., a biotechnology company based in Newark, N.J., that develops breath tests to screen for diseases in their earliest and most treatable stages. The team also will work with Dr. Edward Nardell, a Harvard University pulmonologist with expertise in detecting TB infection.

The scientists will work in CSU’s sealed Biosafety Level-3 facilities, where they will identify unique chemical markers to assist in early detection of TB. Their approach could also help differentiate between drug-susceptible, drug-resistant, and multidrug-resistant strains of TB, which are each treated with different combinations of drugs.

“Tuberculosis is a very difficult disease to diagnose, and the diagnostic process has not changed substantially in the last 50 years,” said Phillips, founder and CEO of Menssana Research. “Currently, a chest X-ray or a sputum sample and culture are most commonly used to diagnose TB. At Menssana, we have worked for years on developing technology for a TB breath test, and we’ve seen very good preliminary results. We hope this collaborative project with CSU will lead to the development of a quick, cost-effective breath test that can detect TB in its earliest stages.”

In addition to being expensive, current TB tests, including chest X-rays, sputum samples, blood tests and injections, are often inconclusive when used with patients in the early stages of TB. The researchers’ new approach to diagnostics would be accurate and easy to use in poor countries that lack sophisticated health-care systems.

Their work also could improve TB vaccine screening by providing scientists with new tools that could quickly determine whether a vaccine being tested is working.

Tuberculosis research programs at Colorado State also are supported by the National Institutes of Health, the U.S. Food and Drug Administration, the Global Alliance for TB Drug Development, and numerous private foundations.

Tuberculosis Facts:

• Tuberculosis is an infectious disease caused by the pathogen Mycobacterium tuberculosis. The disease is spread from person to person through the air. It most often attacks the lungs, and can also affect the brain, kidneys, and spine.

• TB is the second-leading cause of death from an infectious disease worldwide, after HIV.

• One-third of the world’s population is infected with Mycobacterium tuberculosis. Some people develop TB soon after infection, while others can harbor a latent infection and later develop TB when their immune systems become weak.

• Multidrug-resistant tuberculosis has made it increasingly difficult to curb TB.

• TB occurs in every part of the world; the most significant hot spots are in Asia and Sub-Saharan Africa.

• In 2012, about 10,000 TB cases were reported in the United States.

Sources: the World Health Organization and U.S. Centers for Disease Control and Prevention