There is a world-wide epidemic of pulmonary tuberculosis (TB). Once thought to be a near-conquered disease, pulmonary TB is now killing more people than ever, especially those infected with HIV in developing countries.

Although pulmonary TB can be treated and cured with powerful drugs, many sufferers still go untreated because the disease is difficult to detect.

Detection of pulmonary TB has changed very little in the past thirty years. Usually, high-risk patients in the USA are admitted to a hospital isolation room where sputum samples are collected and studied for the presence of the Mycobacteria that cause the disease. This is expensive and time-consuming, and far beyond the resources of most developing countries.

That is why a rapid, accurate, and cost-effective test for pulmonary TB is urgently needed.

Breath testing could provide such a test. The Mycobacteria that cause pulmonary TB generate a very distinctive pattern of volatile organic compounds (VOCs) when grown in the laboratory. If these VOCs could also be detected in the breath of infected patients, it might provide a new method for detecting active infection with pulmonary TB.

The National Institutes of Health (NIAID) awarded Menssana Research a Phase I SBIR grant to test the feasibility of this idea. We analyzed breath VOCs in hospitalized patients who were being screened for pulmonary TB at New York University Medical Center, New York. We also analyzed the VOCs manufactured by Mycobacteria grown in the laboratory at Saint Vincents Medical Center, New York.

We found that breath biomarkers of oxidative stress clearly distinguished between the "sick" hospitalized patients and normal controls. Also, breath VOCs accurately identified the patients whose sputum samples grew Mycobacteria - the VOC biomarkers in breath and in sputum cultures were very similar (see pdf).

Based on these encouraging findings, NIH/NIAID awarded Menssana Research a Phase II SBIR grant to validate the breath test for pulmonary TB in a larger multicenter international study performed in San Diego, London, and two sites in the Philippines and Mexico. The results, soon to be published in the journal Tuberculosis showed that the breath test identified active pulmonary TB with 85% accuracy.

The US Air Force is currently funding a new study of a point-of-care breath test for active pulmonary TB that delivers results in minutes.