Owlstone Medical Pediatric Disease Breathalyzer CE Approved

Owlstone Medical announced 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.

Source: Owlstone Medical

Spirometrix receives CE for its POC Breathalyzer

Spirometrix, an emerging technology healthcare company focused on research, development and commercialization of novel breath analysis devices for applications in disease diagnosis and management, announced today that its Fenom PRO™ Point-of-Care Breathalyzer has received CE marking and can now be sold in Europe.

Spirometrix Inc., founded in 2011 by Dr. Solomon Ssenyange and Ryan Leard as a personal mission to aid asthma patients in the management of their ailment, focuses on the development and commercialization of novel breath analysis devices for application in diagnosis and management of asthma. In recent years, non-invasive measurement and monitoring of the fraction of exhaled nitric oxide (FeNO) in exhaled breath has become established as the biomarker of asthma. The sensor based technology was licensed from Professor Prabir Dutta’s innovative laboratories at The Ohio State University as the company was founded.

“FeNO monitoring in the management of asthma patients at the point of care has the potential to optimize asthma therapy, improve compliance of medication use and decrease the need for emergency visits and hospitalization,” added James Wolfe, M.D., Clinical Professor of Medicine at Stanford University and a Scientific Advisor to Spirometrix. “It should be noted that both American Thoracic Society and European Respiratory Society have issued guidelines recommending FeNO testing for the assessment, management, and long-term monitoring of asthma.”

A press release can be found from Spirometrix website.