Owlstone snags CE mark for pediatric diagnostic breathalyzer

ReCIVA breathalyzer--Courtesy of Owlstone Medical

Owlstone Medical earned a CE mark for the pediatric version of its diagnostic breathalyzer, which being developed to noninvasively test for cancer, infectious disease and inflammatory disease as well as to match asthma patients to treatment.

Cambridge, U.K.-based Owlstone Medical spun out of Owlstone Inc. earlier this year to develop its ReCIVA disease breathalyzer based on its Field Asymmetric Ion Mobility Spectrometry (FAIMS) tech. The platform uses high-speed gas phase ion separation to detect disease-specific volatile organic compounds in breath, according to the company. It is especially applicable in asthma as volatile organic compounds have demonstrated a correlation with asthma subtypes, which can help match patients to the right medication.

With the CE mark, the pediatric breathalyzer joins its adult counterpart in the £2.5 million EMBER project (East Midlands Breathomics Pathology Node), Owlstone said in a statement. The project aims to create breath-based systems for molecular pathology and clinically validate breathomics as a new way to go about diagnostics.


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“Breath analysis presents a significant opportunity to better predict how a child will respond to certain treatments, including steroids and expensive biologics,” said Owlstone CEO Billy Boyle, in the statement. “In developing a pediatric 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.”

In February this year, Owlstone secured an NHS contract to adapt its breathalyzer for precision medicine for asthma in a bid to cut down on emergency hospital admissions stemming from asthma patients being prescribed the wrong medication. And in June, the company reeled in $7 million to fund ongoing clinical trials of the device in lung and colon cancers.


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