The study will employ patented technology developed by Menssana Research, a leading developer of advanced new breath tests for early detection of a wide variety of illnesses and diseases, and the principal recipient of a $225,000 grant from the NIH.
The study is part of an application process by Menssana to secure approval by the U.S. Food and Drug Administration for this technology and its use in identifying biomarkers for COPD.
Two noted NYU Langone physicians will lead the clinical research: Harvey I. Pass, MD, The Stephen E. Banner Professor of Thoracic Surgery and chief of the Division of Thoracic Surgery, and William N. Rom MD, MPH, The Sol and Judith Bergstein Professor of Medicine and director of the Division of Pulmonary, Critical Care and Sleep Medicine. The NYU Lung Cancer Biomarker Center, directed by Dr. Rom with Dr. Pass as Co-PI, has enrolled more than 1,600 smokers in early lung cancer and COPD detection research.
Under the research protocol, breath samples will be collected from patients with COPD, as well as two comparison groups: one comprising individuals who are healthy, and one comprising patients recently diagnosed with lung cancer. The samples will be analyzed with an advanced technology called two-dimensional gas chromatography with time-of-flight mass spectrometry, which detects around 2,000 different VOCs in breath.
COPD affects an estimated 16 million people in the USA, and it is projected to increase from the sixth to the third most common cause of death worldwide by 2020. According to Dr. Rom, “COPD imposes a serious burden on patients by restricting their everyday activities such as walking up stairs. It also imposes a financial burden on society because of the increased number of hospitalizations that are needed to treat acute episodes of COPD.”
“A breath test might enable earlier diagnosis of COPD,” adds Dr. Pass. “That, in turn, can help us better monitor response to treatment, as well as help focus care better by identifying subtypes of patients who would benefit from tailored treatments.”
Menssana Research has developed breath analysis tools for numerous diseases, including the BreathLink™ system, a point-of-care breath test that identifies patients at high risk of breast cancer and active pulmonary tuberculosis in less than ten minutes. This technology has European Regulatory Approval (CE Mark) for both breast cancer and pulmonary tuberculosis. In addition, the FDA has approved the company’s Heartsbreath™ test for heart transplant rejection with a Humanitarian Device Exemption.
Michael Phillips, MD, founder and CEO of Menssana Research, said: “Breath tests are rapid, accurate, cost-effective and safe. We are delighted to have pulmonary experts from NYU Langone Medical Center working with us on this latest clinical trial that, hopefully, will lead to major advances in detecting and treating COPD.”