Owlstone Medical introduces breath biopsy panel for respiratory diseases

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 different types of chronic inflammatory airway diseases 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 the 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 the 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 the 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 subtypes.

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.”

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