- Panel supports research to distinguish between types of chronic inflammatory airway disease including Asthma, COPD and IPF
- Enables direct characterization of disease biology by non-invasively sampling the airways
- First commercial launch from pipeline of Breath Biopsy RUO Panel and IVD tests
Cambridge, UK, January 19, 2021: Owlstone Medical, the global leader in Breath Biopsy® for applications in early disease detection and precision medicine, today introduced the Respiratory Diseases Research Use Only (RUO) Panel. The breath biomarker panel, which is now commercially available, is intended to support research to distinguish between types of chronic inflammatory airway disease including Asthma, Chronic Obstructive Pulmonary Disease (COPD), and Idiopathic Pulmonary Fibrosis (IPF), and to facilitate better therapeutic decision making and monitoring.
Owlstone Medical’s Respiratory Diseases RUO Panel consists of a set of biologically relevant Volatile Organic Compounds (VOCs) that have been linked to inflammatory respiratory diseases, and can be easily collected on breath to enable direct characterization of disease biology in the lungs by non-invasively sampling the airways.
Available as an early output from the Company’s test development process and supported by scientific publications and Breath Biopsy client study data, the Panel will initially be offered for Research Use Only as part of an expanded Breath Biopsy Products and Services offering to supplement the Breath Biopsy OMNI Assay. It will be used by pharmaceutical and academic/clinical research clients to support therapeutic development through characterization of disease endotypes and monitoring response to therapy, and to better understand the onset, development and exacerbation of disease. Building from this Panel, an in vitro diagnostic (IVD) is intended to be developed to support treatment decision making through patient stratification and monitoring of therapeutic response.
Chronic inflammatory airway diseases are caused by a wide range of biological processes that result in significant loss of pulmonary function and quality of life. The impact is enormous with an estimated 339 million people worldwide suffering from asthma and a further 328 million from COPD, which is the third highest cause of death today and has been projected to become number one within 15 years.
Despite having substantial differences in underlying causes, these diseases are similar in clinical presentation, making them difficult to diagnose and deliver effective treatments. Unfortunately, there are currently no cost-effective and patient-friendly ways to characterize airway inflammation. This problem is underscored by an increasing number of drugs being developed that target specific molecular mechanisms, and so are effective for a subset of patients but have limited or no impact for others.
Key to development of the Respiratory Diseases RUO Panel were client studies performed utilizing the Company’s Breath Biopsy Products and Services. Through 17 separate studies, almost 4,000 breath samples were analyzed from which the core VOCs in the Panel were detected. In line with the Company’s approach of selecting the most specific and relevant biomarkers for any application, these were augmented through the exclusive in-licensing of a further set of biomarkers from the University of Liege that linked specific VOCs with inflammatory subtypes1.
Billy Boyle, co-founder and CEO at Owlstone Medical, said: "The Respiratory Diseases RUO Panel is the first to be commercially launched by Owlstone Medical and opens an important new phase in the application of breath to address areas of high clinical need. Building on our recent announcement on the use of limonene as an EVOC® probe in NASH/NAFLD, this Panel further validates our strategy of identifying promising biomarkers from multiple sources including endogenous discovery, EVOC probes, and in-licensing. We look forward to making further announcements as our robust test pipeline continues to develop."
Join Owlstone Medical’s upcoming webinar January 27, 2021 - Discovery and Clinical Investigation of Non-Invasive Biomarkers using Breath Biopsy.
Notes to Editors:
For more information please contact:
Sarah Jeffery, Zyme Communications
+44 (0) 7771-730919
Frazer Hall, Citigate Dewe Rogerson
+44 (0) 20 7282 2822
About Chronic Inflammatory Airway Diseases:
Chronic inflammatory airway diseases are caused by a wide range of inflammatory pathways that result in significant loss of pulmonary function and quality of life. Asthma, chronic obstructive pulmonary disease (COPD), and idiopathic pulmonary fibrosis (IPF) are the most relevant diseases in this group. These diseases are similar in that they cause shortness of breath through airflow limitation, however they also have important differences based on underlying cause.
Asthma is better described as a syndrome rather than as a disease, with several underlying mechanisms responsible for inflammation. There is now a move towards a precision medicine approach in asthma, with research focusing on the development of targeted biologic drugs that have fewer side effects and greatly enhanced efficacy in their target populations. Asthma affects an estimated 339 million people globally1 and in the United States alone approximately 856,000 patients2 suffer from severe uncontrolled asthma, leading to almost two million emergency room visits3, and an annual economic cost of $81.9B4.
COPD refers to a group of diseases that cause airflow blockage and breathing related problems. COPD is usually progressive, and exacerbations, which are typically related to viral or bacterial infections, are a major cause of lung function decline. An estimated 328 million people have COPD worldwide, and COPD has been projected to become the world’s leading cause of death within 15 years5.
IPF is a form of interstitial lung disease, primarily involving the interstitium (the tissue and space around the air sacs of the lungs) and not directly affecting the airways or blood vessels, that results in scarring of the lungs. Over time, the scarring gets worse and it becomes hard to take in a deep breath and so the lungs cannot take in enough oxygen. The disease affects 3 million people worldwide6.
- Bel, E. H. et al. Diagnosis and definition of severe refractory asthma: an international consensus statement from the Innovative Medicine Initiative (IMI). Thorax 66, 910–917 (2011)
What is Breath Biopsy®?
Breath Biopsy represents an entirely new way to determine the chemical makeup of breath by measuring volatile organic compounds (VOCs), gaseous molecules that can be sampled quickly and non-invasively. VOCs originate from all parts of the body as the end product of metabolic processes, making Breath Biopsy applicable to a wide range of diseases including cancer, liver disease, and respiratory disease. Breath also contains microscopic aerosol particles from the lungs and airways, which can contain a wide range of biomarkers including for infectious disease. The nature of Breath Biopsy therefore makes it perfectly suited to addressing two of the major challenges of healthcare today: early detection of disease and precision medicine.
Breath collection is carried out using Owlstone Medical’s ReCIVA® Breath Sampler, which ensures reliable, reproducible collection of VOCs. Samples of exhaled breath are captured and stabilized on Breath Biopsy Cartridges, which can then be shipped to Owlstone Medical’s Breath Biopsy lab for analysis, using Thermo Fisher Scientific Orbitrap™ 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 by realizing the enormous promise of breath-based diagnostics through the development and application of Breath Biopsy®. 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, U.K. with support through our office in Research Triangle Park, NC, USA, 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 development of Tests and RUO Panels for the early detection of disease with an emphasis on cancer, and on precision medicine with an emphasis on liver and respiratory disease. The Breath Biopsy OMNI (Owlstone Medical Novel Insights) Assay is Owlstone Medical’s comprehensive solution for end-to-end breath sample collection and VOC analysis, which is being deployed with large pharma including AstraZeneca, Actelion Pharmaceuticals (a J&J company), and GlaxoSmithKline, and leading academic institutions. Owlstone Medical’s technology is currently in use at over 100 sites worldwide.