The partnership between Owlstone Medical and the International Association of Heat and Frost Insulators and Allied Workers (IAHFIAW), formerly known as the Asbestos Workers, aims to address the need for early detection by using Breath Biopsy® to examine the chemicals found on the breath of individuals with documented historical exposure to asbestos and radiologically and histologically confirmed mesothelioma.
The project will be divided into two phases and is expected to run for three years. It will be financially supported by Heat and Frost Insulators’ Tissue Bank Asbestos Research Charitable Trust nonprofit. The first phase, approved on April 24, will focus on identifying volatile organic compounds (VOCs) found in the breath of individuals diagnosed with malignant mesothelioma.
The second phase will be a blind study to verify the sensitivity, specificity and positive and negative predictive values of selected VOC biomarkers identified in the first phase. Breath samples will be collected using Owlstone Medical’s ReCIVA® Breath Sampler and will be analyzed by their state-of-the-art Breath Biopsy laboratory in Cambridge, UK. The study will be led by Principal Investigator Dr. Michael R. Harbut, and co-Investigator Dr. David Svinarich, Ascension Healthcare's2 Vice President of Research.
Malignant mesothelioma is a rare, aggressive and treatment-resistant disease caused almost exclusively by exposure to asbestos and asbestiform fibers. Early detection of the disease is highly challenging, as a long latency period of 40-50 years between first asbestos exposure and disease onset is typical, and symptoms, when present, may be non-specific. As a result, patient prognosis is poor, with a median survival of nine to 12 months from diagnosis.
Although the disease is not common (3,200 new cases3 per year in the USA), the at-risk population is substantial with more than 100 million people in the U.S. alone having been exposed to asbestos fibers and a further 1.3 million4 American workers in the construction and general industry alone exposed to asbestos on the job each year.
The identification of individuals among this population who are either predisposed to developing malignant mesothelioma, or who already have early disease stage, would likely dramatically improve prognosis by limiting disease progression through earlier therapeutic interventions. Unfortunately, due to the perceived rarity of malignant mesothelioma, little research has been conducted to date on either the early identification or treatment of individuals with disease.
James P. McCourt, General President, IAHFIAW commented: “The population of those who have been exposed to asbestos and are at risk of having existing early-stage disease or developing malignant mesothelioma later in their lives includes a substantial portion of our membership. The long-term health of our members is of primary importance to the IAHFIAW, and we are confident that our partnership with Owlstone Medical will provide significant advances in the early diagnosis of this disease.”
Michael R. Harbut, MD, MPH; Clinical Professor of Internal Medicine at Wayne State University School of Medicine and Michigan State University College of Human Medicine, and medical advisor to the IAHFIAW, said: “The diagnosis of malignant mesothelioma is typically very late in the course of the disease when surgery is not viable owing to its proliferation, and the cancer is less responsive to chemotherapy. To change this, reliable diagnostic tests that enable the earlier detection of malignant mesothelioma in at-risk populations are badly needed.”
Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Malignant mesothelioma is a powerful example of an unaddressed medical need where Breath Biopsy has the potential to make a substantial difference. Through this partnership, we are looking not only to advance the early diagnosis of malignant mesothelioma, but also to demonstrate that breath-based screening has the potential to have a substantial impact on a wide range of environment-driven disease.”
Notes
1. Michael R. Harbut, MD, MPH
Dr. Michael Harbut is an internationally known physician/scientist who is expert in the study, diagnosis, treatment and prevention of diseases of the environment and workplace. Holding Clinical Professorships at the Michigan State University College of Human Medicine and the Wayne State University School of Medicine, Dr. Harbut maintains a clinical practice in the treatment of patients who believe they have been harmed by the environment or workplace.
· Authored a published paper on the cause of intractable pleural pain associated with asbestos-related pleural plaques (International Journal of Occupational and Environmental Health) and co-authored three papers on serum biomarkers of mesothelioma.
· Served as the Medical Coordinator of the American sector of the Kimbumba Rwandese refugee camp in Goma, Zaire during the Rwandan civil war. This sector of the camp had a death rate at 30% of the remainder of the camp.
· Was the Chief Medical Advisor to Poland's Solidarity Union under the U.S. Agency for International Development
2. Ascension Healthcare is the largest Catholic health system in the world and the largest non-profit health system in the United States
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4406225/
4. https://www.atsdr.cdc.gov/csem/csem.asp?csem=29&po=7