Owlstone Medical Launches Breath Testing for Digestive Health in Collaboration with Functional Gut Diagnostics and Functional Gut Clinic

• Testing enables patients to take better control over their digestive health through a simple at-home breath test
• Lab Services Agreement to support efficient scaling of SIBO and Food Intolerance breath testing and further grow volumes with private and NHS patients
• Collaboration Agreement to improve diagnosis of digestive diseases by developing novel breath tests on the Breath Biopsy platform

Cambridge, UK, May 18, 2021: 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.”

Billy Boyle, co-founder and CEO at Owlstone Medical, said: “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.”

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/

Owlstone Medical’s new webpages include more about our work in digestive health, with information for researchers or for clinicians and patients.

1. https://gutscharity.org.uk/advice-and-information/conditions/irritable-bowel-syndrome/
2. https://www.bjmp.org/content/irritable-bowel-syndrome-primary-care-physicians
3. https://pubmed.ncbi.nlm.nih.gov/29761234/
4. https://www.aboutibs.org/facts-about-ibs/statistics.html

ENDS

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About hydrogen/methane breath testing (HMBT):

Hydrogen and methane are well established breath biomarkers that provide insights into the conditions that underlie digestive discomfort. HMBT is a simple, patient-friendly, non-invasive, and cost-effective method to detect SIBO or carbohydrate malabsorption, and so can help clinicians develop a plan to control their patients’ symptoms through medications and dietary and lifestyle change.

HMBT offered by OML and FGD is simple and convenient, with patients able to perform the test in the comfort of their own homes through easy to follow instructions. Upon completion of sampling, test kits are returned to OML in a prepaid envelope for analysis¹ and test reports are provided by FGD with accompanying interpretation from internal clinical experts to better support their effective use as part of a treatment plan. Follow-up consultations are available upon request.

1. Testing is compliant with guidelines including Hydrogen and Methane-based Breath Testing in Gastrointestinal Disorders: The UK Consensus – Association of GI Physiologists and the British Society of Gastroenterology

About Owlstone Medical (owlstonemedical.com):

Owlstone Medical’s mission is to save 100,000 lives by realizing the enormous promise of breath-based diagnostics through the development and application of Breath Biopsy^®. The Breath Biopsy platform includes ReCIVA^® Breath Sampler, a proprietary sample collection device that can take stable breath samples anywhere, the world’s only commercial Breath Biopsy Laboratory located in Cambridge, U.K. with support through our office in Research Triangle Park, NC, USA, and the development of the world’s largest Digital Breath Biobank matched to patient phenotype.

Owlstone Medical is deploying the platform to address some of the key challenges of 21^st century healthcare. The focus is on the development of Tests and Research Use Only Panels for the early detection of disease with an emphasis on cancer, and on precision medicine with an emphasis on liver and respiratory disease. The Breath Biopsy OMNI (Owlstone Medical Novel Insights) Assay is Owlstone Medical’s comprehensive solution for end-to-end breath sample collection and VOC analysis, which is being deployed with large pharma including AstraZeneca, Actelion Pharmaceuticals (a J&J company), and GlaxoSmithKline, and leading academic institutions. Owlstone Medical’s technology is currently in use at over 100 sites worldwide.

About Functional Gut Diagnostics (functionalgutdiagnostics.com):

Functional Gut Diagnostics’ mission is to provide the latest diagnostic technologies, test equipment, analysis, research, and training to enable exceptional patient care in functional gastroenterology and disorders of the gut brain axis. By combining our clinical, scientific, and technical expertise, Functional Gut Diagnostics connects clinicians with precisely the right solution for their patients. Functional Gut Diagnostics is the UK distributor for Diversatek Healthcare/Sandhill gastroenterology products and Commonwealth Diagnostics International’s (“CDI”) portfolio of ISO13485-certified, CE Marked non-invasive hydrogen and methane breath test kits.

Founded on clinical knowledge and laboratory expertise, Functional Gut Diagnostics (FGD) pushes the boundaries of research in the field of functional gut disorders by running and participating in collaborative research and clinical trials.  The outcomes and knowledge gained is disseminated to further advance the understanding and treatment of gastrointestinal problems.

FGD was established by Dr Anthony Hobson in 2014 to complement the clinical activity already underway at The Functional Gut Clinic.  In 2017, FGD entered into a transformational joint venture with Craig Strasnick and the visionary team at Commonwealth Diagnostics International to bring CDI’s industry leading hydrogen and methane breath test kits to the UK. The shared values of FGD and CDI have already seen a hugely successful roll out of its unique hydrogen and methane breath test kits in the UK, a development which was recently acknowledged as ‘outstanding’ by the CQC in terms of improving patient choice and accessibility. FGD is committed to growing and developing its product portfolio to ensure patients have access to the highest quality diagnostic tools to help improve their quality of life.

About Functional Gut Clinic (thefunctionalgutclinic.com):

The Functional Gut Clinic was founded by Dr Anthony Hobson in 2014, in response to a general apathy within healthcare about how people suffering with GI-related conditions were treated. The Functional Gut Clinic’s mission is to bring peace of mind to millions by providing fast, accurate diagnosis and management for GI-related conditions.  By working as a medical resource that complements GPs and consultants, the Functional Gut Clinic delivers unrivalled problem-solving at every stage of the gut and digestive system.

The Functional Gut Clinic is dedicated to providing the very latest diagnostic technology with a team of patient care specialists in our specialist gut clinic to offer a trusted, proven and reliable service that swiftly identifies the problem; then connects patients with precisely the right treatment to alleviate symptoms or address the underlying issue. The Functional Gut Clinic is the only gastrointestinal physiology service in the UK to receive an IQIPS (Improving Quality in Physiological Services) accreditation.  The Functional Gut Clinic is also regularly inspected by the Care Quality Commission, the independent regulator for healthcare businesses. The Functional Gut Clinic now operates three clinics, located in Manchester, London and Cambridge with satellite clinics around the UK.