Seeking breath-based biomarkers for mesothelioma

Cambridge, UK, and Lanham, MD—Owlstone Medical 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. The partnership intends to identify and verify breath-based biomarkers for the early detection of malignant mesothelioma.

The partnership between Owlstone Medical and IAHFIAW 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 IAHFIAW’s 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, U.K. The study will be led by principal investigator Dr. Michael R. Harbut, and co-investigator Dr. David Svinarich, Ascension Healthcare’s vice president of Research.

“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,” said Michael R. Harbut, M.D., M.P.H.; 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. “To change this, reliable diagnostic tests that enable the earlier detection of malignant mesothelioma in at-risk populations are badly needed.”

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 cases 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 million American workers in the construction and general industry alone exposed to asbestos on the job each year.

“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,” noted James P. McCourt, general president, IAHFIAW.

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.

Added Billy Boyle, co-founder and CEO at Owlstone Medical, “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.”

In late May, Owlstone also entered into a strategic collaboration with Actelion Pharmaceuticals Ltd to develop a breath-based test to help facilitate the early detection of pulmonary hypertension and its subtypes. The development program will be solely funded by Actelion.

Early diagnosis of pulmonary hypertension (PH) is very difficult and even at an advanced stage presents similarly to other heart and lung conditions, so a delay of years between the onset of symptoms and diagnosis and treatment is common. There is an urgent need for effective tools to facilitate screening and early diagnosis of PH patients.

The collaboration will initially involve collecting breath exhaled VOCs from over 1,000 patients using Owlstone Medical’s ReCIVA from sites in the U.K., U.S. and other countries in the EU. VOCs will be analyzed by Owlstone Medical to identify those associated with PH, in order to develop biomarker signatures for earlier detection of the disease.

“Owlstone Medical was founded with the objective of improving the early diagnosis of disease in order to save lives through the application of Breath Biopsy. This strategic collaboration with Actelion, which is focused on improving the lives of those suffering from PH and PAH, represents a tremendous opportunity to do just that,” Boyle explained in a press release. “We believe Breath Biopsy will deliver a program from discovery through to the launch of a test to the market, and this novel approach will make a real difference for the healthcare of patients suffering from PH.”