Owlstone Medical, a diagnostics company developing a breathalyzer for disease,announced it has signed a master service agreement with 4D Pharma plc, a pharmaceutical company focusing on the development of live biotherapeutics. As part of the agreement, 4D Pharma will use Owlstone Medical’s Biomarker Services to discover novel non-invasive biomarkers present in breath that can be applied to the development of effective therapeutics for a wide range of diseases from cancer, to gastrointestinal, autoimmune, and respiratory conditions.

The pattern of Volatile Organic Compounds (VOCs) present in exhaled breath is directly linked to the metabolic processes taking place within the body as well as exogenous sources such as an individual’s microbiome, the many millions of bacteria that colonize the body and play an important role in health and disease.

4D Pharma is developing live biotherapeutics, a revolutionary class of medicines that harness the functionality of the microbiome. The company is using Owlstone Medical’s Biomarker Services to identify novel VOC biomarkers in breath for use in disease diagnosis and stratification to match patients to the most appropriate treatment.

Breath Biopsy samples will be collected from patients at 4D Pharma’s clinical trial site using Owlstone Medical’s ReCIVA Breath Sampler. Breath samples stored in stable sorbent tubes are then transferred to Owlstone Medical’s service laboratory in Cambridge, UK, for VOC analysis using the company’s FAIMS platform to analyze spectral data and develop classification algorithms.

Billy Boyle, co-founder and CEO at Owlstone Medical, said: "Our Biomarker Services draw on the experience we have developed through our pioneering work on Breath Biopsy technology and the large breath biomarker clinical trials we are running as part of our own clinical pipeline. We are excited to enable 4D Pharma to discover VOC biomarkers for patient stratification in their own therapeutic programs."

Paul O’Toole at 4D Pharma Cork Ltd commented: "We are very pleased to initiate this Breath Biomarker Services project with Owlstone Medical. VOCs in breath provide incredibly valuable information about the health of an individual as well as potentially reflecting the metabolism of their microbiome. As such, VOC biomarkers show great potential for patient stratification and could help us to determine which patients would benefit most from our live biotherapeutics."