Newswise — New York, NY (August 25, 2014) -- NYU Langone Medical Center will lead a new clinical initiative -- funded by a $225,000 grant from The National Institutes of Health -- to determine a breath test’s effectiveness to identify volatile organic compounds (VOCs) in human breath that are biomarkers of chronic obstructive pulmonary disease (COPD). 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 the NIH grant.
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.”
About NYU Langone Medical Center:NYU Langone Medical Center, a world-class, patient-centered, integrated academic medical center, is one of the nation’s premier centers for excellence in clinical care, biomedical research, and medical education. Located in the heart of Manhattan, NYU Langone is composed of four hospitals — Tisch Hospital, its flagship acute care facility; Rusk Rehabilitation; the Hospital for Joint Diseases, the Medical Center’s dedicated inpatient orthopaedic hospital; and Hassenfeld Children’s Hospital, a comprehensive pediatric hospital supporting a full array of children’s health services across the Medical Center — plus the NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The Medical Center’s tri-fold mission to serve, teach, and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education, and research. For more information, go to www.NYULMC.org, and interact with us on Facebook, Twitter, and YouTube.