Cambridge, UK, and Lanham, MD, USA June 05, 2019: Owlstone Medical, a global diagnostics company developing a breathalyzer for applications in early disease detection and precision medicine, announced today the formation of a partnership with the International Association of Heat and Frost Insulators and Allied Workers (IAHFIAW), formerly known as the Asbestos Workers, a building trades union in the United States and Canada, to identify and verify breath-based biomarkers for the early detection of malignant mesothelioma.
The partnership between Owlstone Medical and the Heat and Frost Insulators 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 at Owlstone's 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 to Editors:
- 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
- Ascension Healthcare is the largest Catholic health system in the world and the largest non-profit health system in the United States
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About IAHFIAW (www.insulators.org):
Since 1903, the International Association of Heat and Frost Insulators and Allied Workers has worked to assist its membership in securing employment, to defend their rights and advance their interests as working men and women, and by education and cooperation, raise them to that position in society to which they are justly entitled.
The IAHFIAW is affiliated with the AFL-CIO and the Canadian Labour Congress and represents nearly 30,000 highly skilled and highly trained workers in the construction trades.
Today’s union insulator is skilled in the installation of mechanical insulation, fire stopping, asbestos and lead mitigation or abatement, sound attenuation and specialty fabrications required in custom mechanical insulation installations for commercial, industrial, medical, bio-technical, governmental and educational facilities among other customer types. This work is installed by our professional mechanical insulators that have achieved journeyman status in the union through a multi-year classroom and 1,600 hour per year on-the-job training program.
Each year, members raise and donate over a million dollars to fund research for asbestos-related diseases.
The IAHFIAW understands the dangers of asbestos and continues to fund research to find a cure for the insidious diseases it causes through a number of initiatives, including multiple research and medical partnerships throughout the United States and Canada and the creation of the Insulators’ Tissue Bank Asbestos Research Charitable Trust, which was created through a partnership with Mt. Sinai Medical Center. This repository uses actual tissue samples from people with documented exposure to asbestos in the laboratory to find new ways to diagnose, treat and prevent asbestos-related conditions, including mesothelioma.
The Tissue Bank Asbestos Research Charitable Trust is a recognized 501 (c) (3) – Non-profit entity. Contributions/Donations are tax deductible to the extent permitted by law. Tissue Bank Asbestos Research Fund Tax ID No. 35-2457233
What is Breath Biopsy®?
Breath Biopsy represents an entirely new way to measure the chemical makeup of breath by measuring volatile organic compounds (VOCs), which are gaseous molecules that can be sampled quickly and non-invasively from breath and enabling whole-body sampling. These compounds are produced as the end product of metabolic processes within the body, meaning underlying changes in metabolic activity can produce particular patterns of VOCs characteristic of specific diseases.
VOCs originating from all parts of the body are captured in breath, making Breath Biopsy applicable to a wide range of diseases including cancer, inflammatory disease, infectious disease, metabolic disease, cardiovascular disease and respiratory disease. The nature of Breath Biopsy, and VOC biomarkers, make them perfectly suited to addressing two of the major challenges of healthcare today: early detection and precision medicine.
Breath collection is carried out using Owlstone Medical’s ReCIVA Breath Sampler, which ensures reliable, reproducible collection of VOCs. Subjects breathe a controlled supply of air, and samples of their exhaled breath are captured and stabilized on Breath Biopsy Cartridges, which can then be shipped for analysis with Owlstone Medical’s Breath Biopsy analytical platform, using mass spectrometry or FAIMS to determine their VOC profile. Advanced data analytic techniques can then be applied in order to pinpoint the VOCs of interest.
About Owlstone Medical (www.owlstonemedical.com):
Owlstone Medical’s vision is to save 100,000 lives and $1.5 billion in healthcare costs by realizing the enormous promise of breath-based diagnostics through the development and application of Breath Biopsy®. Breath Biopsy operates by detecting volatile organic compounds (VOCs) produced as the end product of metabolic processes within the body or as a result of chemicals from external sources such as diet or medication, changes in which can be characteristic of specific disease or indicate environmental exposure.
The Breath Biopsy platform includes ReCIVA®, a proprietary sample collection device that can take stable breath samples anywhere, the world’s only commercial Breath Biopsy Laboratory located in Cambridge, UK, and the development of the world’s largest Digital Breath Biobank matched to patient phenotype.
Owlstone Medical is deploying the platform to address some of the key challenges of 21st century healthcare. The focus is on the early detection of disease with an emphasis on cancer, with clinical trials underway to develop breath tests for the early detection of lung and colorectal cancer, and on precision medicine through partnerships with large pharmaceutical companies including AstraZeneca and GlaxoSmithKline to enable therapeutics to be deployed more effectively. Owlstone Medical’s technology is currently in use at over 100 sites worldwide.