Owlstone Medical (“OML”), the global leader in Breath Biopsy® for applications in early disease detection and precision medicine, today announced agreements with Functional Gut Clinic (“FGC”) and Functional Gut Diagnostics (“FGD”), leading providers of smart solutions for the diagnosis of gut health problems.

The partnership aims, by combining OML’s expertise in breath-based testing with FGC and FGD’s leadership in digestive health, to strengthen the provision of efficient and high-quality at-home breath testing through a UK Lab Services Agreement and accelerate development of future breath tests in digestive health through a Collaboration Agreement.

Over 1 billion people worldwide1 suffer from digestive health issues including Irritable Bowel Syndrome (IBS), Small Intestine Bacterial Overgrowth (SIBO), food malabsorption, and other causes. In the UK alone almost 9 million adults experience IBS2, and 3.4 million SIBO3. Digestive health is also cited as one of the leading causes of work absenteeism and global direct and indirect costs are estimated at $21 billion annually4. Unfortunately, symptoms overlap considerably and so many suffer for years with these conditions without a clear solution.

Hydrogen and methane are well-established breath-based biomarkers in SIBO and Food Intolerance. This process works similarly to how Owlstone Medical’s EVOC® Probes are being deployed in areas such as liver disease, using an external substrate to induce a clear and biologically relevant measurement on breath.

The Lab Services Agreement between OML and FGD will support FGD’s at-home SIBO and Food Intolerance offering in the U.K., helping to scale operations through the provision of efficient and cost-effective management of laboratory testing and sample kit manufacturing at OML’s U.K. headquarters. OML will also provide commercial support to raise awareness of SIBO and Food Intolerance to drive testing volumes across a broad range of customers.

Furthermore, OML, FGC, and FGD, have entered into a Collaboration Agreement to expand the menu of available breath-based tests in the area. The partnership aims to discover, validate and commercialize novel tests by linking volatile organic compounds (VOCs) detectable in breath samples to digestive health disorders, with a first study initiated on gut dysbiosis.

Under the Agreement, tests developed will be made available to clinical customers in the U.K. through FGD, and Commonwealth Diagnostics International (Salem, MA), one half of the FGD joint venture, is expected to make tests available in the United States.

Anthony Hobson, Director of FGD and FGC, commented: “We know that most currently available diagnostic testing for digestive health isn’t good enough. For too long, patients have been living with unresolved gut health problems and losing control of their lives. This is why we combine the very latest diagnostic technology with a team of dedicated specialists to offer a trusted, proven and reliable service to swiftly identify the problem. Our partnership with OML will enable us to expand on this idea through the efficient scaling of hydrogen/methane breath testing, and by building an exciting new suite of tests to support the millions of patients who suffer and struggle to control their symptoms in a new and highly impactful way.”

At Owlstone Medical, our mission is to have a substantial impact on the lives of patients by deploying breath testing into high need clinical areas. We are therefore interested in adding established biomarkers to our portfolio, and the measurement of hydrogen and methane following ingestion of a substrate, similarly to how our EVOC probes operate, represents a very attractive opportunity to do so.

Further, the deep digestive health experience, access to patients, and specialized clinical support made available through our collaboration with FGC and FGD, alongside our full breath biomarker discovery capability, provides a very real opportunity to develop an exciting pipeline of breath tests to enable patients to take better control over their gut health.”

Billy Boyle, co-founder and CEO at Owlstone Medical

A recording of Owlstone Medical’s recent webinar with Dr. Anthony Hobson April 14th, 2021 – Breath Biopsy® and Digestive Health Testing is available for viewing here: https://www.owlstonemedical.com/download/digestive-health-testing-webinar/