Owlstone Medical Receives CE Mark Approval for ReCIVA™
News Oct 05, 2016
Owlstone Medical has announced that it has developed and received CE mark approval for a paediatric version of the company’s disease breathalyzer, ReCIVA™. The marking extends the scope of breath testing in early stage diagnostics and therapy response to include children and in particular, the difficult to manage group of child asthma patients. Both the adult and pediatric versions of the breathalyzer are now being used in EMBER (East Midlands Breathomics Pathology Node), a £2.5 million project, funded by the Medical Research Council (MRC) and the Engineering and Physical Sciences Research Council (EPSRC).
The primary aim of EMBER is to develop breath-based systems for molecular pathology of disease and clinically validate breathomics as a new diagnostic modality. Currently one in 11 children in the UK has asthma and it is the most common long-term medical condition. Volatile organic compounds (VOCs) in breath have been shown to correlate to inflammatory subtype in asthma, which helps guide better treatment decisions. Owlstone Medical uses the Respiration Collector for In Vitro Analysis (ReCIVA), in combination with the Field Asymmetric Ion Mobility Spectrometer (FAIMS) sensor platform, to accurately and selectively detect volatile organic compounds (VOCs) in breath.
In February, the company won an NHS contract for STRATA (Stratification of Asthma Treatment by Breath Analysis) to adapt its disease breathalyzer technology for precision medicine and companion diagnostics in asthma. The paediatric version of ReCIVA is suitable from ages 5 and up and has been developed as breath sampling offers a completely non-invasive way to test children. EMBER was established by the MRC and EPSRC as an academia/industry consortium to develop breath-based systems for molecular pathology.
EMBER draws upon expertise in clinical research, analytical chemistry, data management and mathematical modelling of complex data across the East Midlands to develop rapid, near patient non-invasive approaches to diagnosis, phenotyping and stratification. Billy Boyle, co-founder and CEO at Owlstone Medical commented: “Managing the diagnosis and treatment of children presenting with asthma and severe breathing difficulties is often problematic. Breath analysis presents a significant opportunity to better predict how a child will respond to certain treatments, including steroids and expensive biologics.
In developing a paediatric breath sampler we are expanding the scope of projects such as EMBER to include children as an important group in the study of asthma, and more generally extending other biomarker and discovery studies using breath.” Professor Chris Brightling, EMBER and Leicester NIHR Respiratory Biomedical Research Unit Director, Professor in Respiratory Medicine at University of Leicester, Precision Medicine Institute added: “Choosing the right treatment for the right patient is especially challenging in children as obtaining samples such as blood to measure disease activity can be difficult. Breath analysis offers an excellent opportunity to sample the airway by simply breathing into a mask. This presents a new approach to understand disease and make better treatment decisions”.