Oct. 5, 2016—Owlstone Medical has received CE mark approval for a pediatric 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.
The adult and pediatric versions of the breathalyzer are being used in East Midlands Breathomics Pathology Node, a $2.8 million project dubbed EMBER, which is funded by the U.K.’s Medical Research Council and the Engineering and Physical Sciences Research Council. 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.
Volatile organic compounds 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, known as ReCIVA, along with the Field Asymmetric Ion Mobility Spectrometer sensor platform, to accurately and selectively detect the breath compounds. The pediatric version of ReCIVA is suitable from ages five and up.
In a separate announcement, the Cambridge, England-based diagnostics company said it is expanding its Lung Cancer Indicator Detection clinical trial. The study, originally funded by the Small Business Research Initiative for Healthcare, an NHS England-funded program, aims to save 10,000 lives and save the NHS $274 million by 2020 with a breath test to detect lung cancer. The study will recruit up to 3,000 patients across 21 sites in the U.K. and Europe, making it the world’s largest breath-based study ever undertaken for early cancer detection.